News Archive

Pharmaceutical Liability News

Judge Asks Appeals Court to Uphold Dismissal of Consolidated HRT Cases
A Philadelphia judge has asked the Pennsylvania Superior Court to uphold a series of rulings dismissing the claims of plaintiffs who allege that the manufacturers of their hormone replacement therapy drugs are liable for their breast cancer. Fourteen cases decided by a Philadelphia Common Pleas judge have been consolidated for consideration by a single Superior Court panel. The Common Pleas judge granted defense motions for summary judgment in all of the cases because, he said, there was sufficient public information at the time all of the plaintiffs were diagnosed with breast cancer for the plaintiffs to learn that there was a risk of developing breast cancer from taking HRT drugs. He also noted that product package inserts warned of an increased risk of breast cancer. The pharmaceutical defendants are Wyeth Pharmaceuticals and Pharmacia.  

FDA Reviewing Abuse-Resistant Pain Drug
The Food and Drug Administration is still reviewing King Pharmaceuticals Inc.'s pain drug candidate Embeda. Embeda capsules contain an extended-release dose of morphine and a core of naltrexone, a drug that is used to combat addiction. King said that if the pill is crushed or chewed, rather than swallowed as intended, the naltrexone will be released, canceling out the high of the morphine. Pain pills are often abused by users who grind them up to snort or inject. In November, the FDA said Embeda might help deter abuse, but indicated it was not a major improvement on older drugs. The FDA also said there were potential safety issues with exposing patients to naltrexone.   

Drugmaker Pays $2.6 Million Over Off-Label Marketing
Nebraska's attorney general has announced that drugmaker Cephalon has paid more than $2.6 million to the state to settle allegations of off-label marketing of three pharmaceutical products. The settlement resolves allegations that Cephalon marketed drugs for uses not approved by the Federal Drug Administration. The drugs are Actiq, a highly addictive painkiller; the anti-seizure drug Gabitril; and the sleep-disorder drug Provigil. The money is part of a $425 million national settlement with state Medicaid programs. 

No More Goodies for Doctors from Drug Makers
Starting January 1, the pharmaceutical industry has agreed to a voluntary moratorium on branded goodies, such as Viagra pens, Zoloft soap dispensers and Lipitor mugs, that were meant to foster good will and, some would say, encourage doctors to prescribe more of the drugs. Some skeptics deride the voluntary ban as a superficial measure that does nothing to curb the far larger amounts drug companies spend each year on various other efforts to influence physicians. But proponents welcome it as a step toward ending the barrage of drug brands and logos that surround, and may subliminally influence, doctors and patients.  

Child Psychiatrist to Curtail Industry-Financed Activities
A prominent Harvard child psychiatrist will curtail activities financed by the drug industry while Massachusetts General Hospital investigates his failure for years to disclose the consulting fees he received from drug makers. The psychiatrist, a world-renowned and controversial researcher on childhood mental illness, has agreed to stop participating in speaking engagements and other activities paid for by pharmaceutical companies. A Congressional investigation found that the psychiatrist had been paid at least $1.6 million in consulting fees by drug makers from 2000 to 2007, but had failed to report much of this income to Harvard officials for several years. 

 

Millions of Older Americans Use Risky Drug Combos
At least 2 million older Americans are taking a combination of drugs or supplements that can be a risky mix. Among older men, the numbers are particularly alarming, with one in 10 taking potentially harmful combinations. The results aren't always disastrous, but older people are more vulnerable to side effects and drug-to-drug interactions. And patients need to know that just because lots of medicines and supplements don't require prescriptions doesn't mean they're harmless. Nor are some of these safe to take when you're prescribed other medications. 

FDA Warns of 28 Diet Pills Sold Online
The Food and Drug Administration is warning consumers not to buy 30 weight-loss products that contain unlisted and possibly dangerous ingredients. The pills are advertised as "natural" fat busters and have names like Imelda Perfect Slim and Zhen de Shou. Some suggest they are innovative "herbal" remedies from Asia. However, the FDA said the concoctions contain unlisted ingredients, including powerful appetite-suppressing drugs and a suspected carcinogen. The FDA warned that "these tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and in some cases prescription drugs in amounts that greatly exceed their maximum recommended dosages. After preliminary investigations, the FDA has identified 28 dietary supplements that could land unsuspecting users in the emergency room. 

Medical Publisher to Review Claims About Article's Writer
Elsevier, a medical publisher, will investigate a senator's recent allegation that one of its journals published an article on hormone replacement therapy that was improperly ghostwritten by a drug company promoting the product. The Republican senator of Iowa raised questions about the May 2003 "Editors' Choice" article in Elsevier's American Journal of Obstetrics and Gynecology. The article, signed by Dr. John Eden, an Australian academic, was among articles the senator has cited that were favorable to drugs made by the pharmaceutical company Wyeth. The senator, who is investigating drug company influences on doctors, contends that Wyeth commissioned the articles and had them ghostwritten by a medical writing firm. Only after the articles were conceived and under way did the firm line up doctors to put their names on them. 

FDA Approves More Drugs, But Still Misses Deadlines
The number of new drugs approved by the Food and Drug Administration has ticked upward in 2008, even as regulators failed to meet review deadlines on more than a dozen drugs. The FDA will approve at least 21 first-of-a-kind drugs this year, up from 18 in 2007. At the same time, analysts say, the agency missed its target review dates for at least 15 drugs. In recent years the drug industry has criticized the FDA for approving fewer new drugs. Many critics suggest the agency has become too cautious in response to deadly side effects of drugs such as Vioxx. 

One Disease, Two Legal Positions in Experimental Drug Case
A 17-year-old boy and a 13-year-old boy, both of whom have the terminal genetic disease Duchenne muscular dystrophy, are on different sides of a landmark case in the 3rd Circuit Court of Appeals that helps set the standard that families should not be able to use litigation to force drug companies into providing experimental drugs before trials prove their safety. A federal district court sided with the family of the 17-year-old boy, ruling that the drug company and the FDA should give the boy the experimental drugs. However, the company appealed to the 3rd Circuit, arguing that courts should not be able to force a company to provide drugs to patients before they are sure about their safety. The family of the 13-year-old boy testified on behalf of the company, arguing that if a court is permitted to force a company to administer experimental drugs, patients may sue to get access to the drugs rather than enter a drug trial to avoid getting a placebo.   

FDA Adds Suicide Warning to Epilepsy Drugs
Federal health regulators are ordering companies that make epilepsy drugs to add warnings about increased risks of suicide to their products. The new warnings apply to blockbuster drugs used by millions of patients to control seizures. The drugs include Lamictal, Topamax and Lyrica. The FDA stopped short of adding its sternest warning to the medications, as it had proposed doing earlier in the year. 

Regulators Allege Illegal Monopoly for Baby Meds
Federal regulators alleged that an Illinois-based company bought the only two medicines approved to treat premature babies born with a potentially life-threatening congenital health defect, and then increased prices nearly 1,300 percent. The Federal Trade Commission said in a civil lawsuit that Ovation Pharmaceuticals Inc. illegally maintained a monopoly in drug treatments for the heart defect. The commission seeks to prevent Ovation from maintaining simultaneous interest in the two drugs. An estimated 30,000 babies are treated with the drugs each year. 

New Study Firmly Ties Hormone Use to Breast Cancer
Taking menopause hormones for five years doubles the risk of breast cancer, according to a new analysis of a big federal study that reveals the most dramatic evidence yet of the dangers of these still-popular pills. Even women who took estrogen and progestin pills for as little as a couple of years had a greater chance of getting cancer. And when they stopped taking them, their odds quickly improved, returning to a normal risk level roughly two years after quitting. Collectively, these new findings are likely to end any doubt that the risks outweigh the benefits for most women.  

Study of Tumor Recurrence May Change Drug Guidelines
A particularly fast-growing form of breast cancer should be treated aggressively after surgery even when tumors are very small, according to new research that could alter treatment for one in five women diagnosed with breast cancer. The research focuses on the 15 to 20 percent of women with breast cancer who test positive for an amplification of the HER2 gene, which is typically among the most aggressive forms of the disease. Currently, a targeted therapy called Herceptin has greatly improved the odds for women with HER2-positive cancer. However, current treatment guidelines do not recommend that the drug be given to women with HER2-positive tumors less than one-half centimeter in size. The guidelines also suggest only that doctors discuss Herceptin treatment with women who have tumors between one-half and one centimeter in size.  

Wyeth's Use of Medical Ghostwriters Questioned
Wyeth, the pharmaceutical company, paid ghostwriters to produce medical journal articles favorable to its hormone replacement therapy Prempro, according to Congressional letters seeking more information about the company's involvement in medical ghostwriting. At least one article was published even after a federal study found the drug raised the risk of breast cancer. The letters ask Wyeth and DesignWrite, a medical writing company, to disclose payments related to the preparation of journal articles and the activities of doctors who were recruited to put their names on them for publication. The letters are part of a continuing investigation by the Senate Finance Committee into drug industry influences on doctors. 

FDA Panel Rules to Keep Advair on the Market
A committee of experts unanimously said Advair was safe enough to remain on the market to treat asthma, but declared two other drugs too risky. The panel convened by the Food and Drug Administration also urged the agency and drug companies to study more carefully whether certain asthma drugs were safe to use in children. The panel of outside experts had been examining the safety of four asthma drugs. Some data have suggested that these drugs increased the risk of hospitalization and death in asthma patients. The panel said that Advair's and Symbicort's benefits outweighed their risks, but found Serevent and Foradil too risky. 

Texas Appeals Court Does About-Face in Vioxx Case
The 4th Court of Appeals in Texas has vacated its decision that tossed out a $7.75 million judgment in a case in which a woman alleged that taking the prescription drug Vioxx caused her 71-year-old husband to suffer a heart attack in 2001. Acting on the plaintiffs' motion for rehearing, the three-justice panel issued a new opinion that reverses the 229th District Court's judgment and remands the case for a new trial because of "juror misconduct." According to the opinion, one juror received interest-free loans totaling $12,700 from the plaintiff over a six-year period beginning in 2000 but failed to disclose that personal financial relationship during voir dire.  

FDA Puts Black Box Warning on Bowel-Clearing Drugs
Federal health officials will add the sternest safety warnings available to prescription drugs used to cleanse the bowel before colonoscopies. The FDA said it has received more than 20 reports of a rare but serious form of kidney failure among patients taking the drugs, known as oral phosphate products. The new boxed warning label will apply to Visicol and OsmoPrep, both prescription tablets made by Salix Pharmaceuticals. The label warns that the drugs should be used with caution in older patients, those that suffer from dehydration and kidney diseases or those that take medications that affect the kidneys. 

FDA Deadlocked on Asthma Drug Risks
Deadlocked over the risks of long-acting asthma drugs, government officials asked outside advisers if four medications used by millions of patients should remain on the market. An unusually large panel of some 30 medical and scientific advisers will vote on whether the risks of the drugs Advair, Foradil, Serevent and Symbicort outweigh the benefits. Doctors who treat adults and children with asthma strongly urged the FDA not to ban the drugs, claiming it would only trigger a dangerous surge in cases of uncontrolled asthma. Other advisers expressed frustration over a lack of fresh clinical data on medications in use for a decade or longer.  

FDA Cites Safety Concerns with Acusphere Drug
Shares of Acusphere plummeted after federal regulators raised serious safety concerns about an imaging drug the company has touted as a potential blockbuster product. Acusphere had asked the FDA to approve its AI-700 formula as an injectable drug to improve the clarity of echocardiograms; however, the FDA said that animal studies of the chemical showed evidence of hypertension, decreased blood pressure and abnormal behavior. The agency is "concerned that the safety risks associated with the product are inappropriate for the product's proposed clinical use." Reviewers also said that the company's two studies do not give a clear picture of the product's effectiveness.  

Asthma Drugs Pose Increased Risks
The Food and Drug Administration has found that three popular asthma medicines may increase risks of hospitalization and death in some asthma patients. The safety of the drugs, which include Serevent, Symbicort and Foradil, will be reviewed by outside medical advisers to the FDA at a two-day hearing. While three of the medications, known as long-acting beta agonists, or LABAs, had a "positive risk difference" in clinical studies, it was only "statistically significant" for Serevent. A fourth drug, Advair, had no increased risk of respiratory complications. Medical experts at the hearing will consider the potential risks of all LABAs, including Advair. The drugs already carry strong warnings, but the findings next week could lead to more specific instructions for patients. 

Penn Medicine to Disclose Doctors' Drug Ties
Patients at the University of Pennsylvania School of Medicine may soon be able to learn whether their doctors are paid on the side by pharmaceutical firms or medical-implant makers. Next year, the hospital will launch a web site that will contain searchable information on all outside activities of its doctors and scientists. Public disclosure of the times between its medical staff and industry would put Penn at the forefront of an emerging trend in response to growing concerns about medical conflicts of interest. 

Risks of New Asthma Drugs Vary
The Food and Drug Administration says Advair, a widely used asthma drug, does not appear to have an increased risk of serious complications seen with some newer medicines. The agency analyzed reams of clinical data on four drugs, including Advair, Foradil, Serevent and Symbicort. All carry strong warnings already, but the findings could lead to more specific instructions for patients. The FDA is concerned about asthma drugs known as LABAs, long-acting medications that relax tight muscles around stressed airways. LABAs can also increase risks of death and complications in some patients.  

Breast Cancer Drug May Cause Tumors to Spread
The most commonly used breast cancer drug may cause tumors to spread in a small number of women with low levels of protein which makes cells stick together, British researchers have found. The findings could lead to new tests to determine which women are not likely to benefit from tamoxifen and who should be given other drugs. Tamoxifen is given to most women for five years after they are diagnosed with breast cancer to prevent the disease from returning, but some develop resistance, which means their tumor is more likely to recur. 

Rite Aid Settles with New York Over Expired Products
New York officials have reached a $1 million agreement with Rite Aid, a national pharmacy chain, to stop sales of expired products, including food, medicine and baby formula. New York's attorney general sued Rite Aid after investigators bought expired goods in 22 percent of Rite Aid stores statewide. The company will pay a penalty of $1 million and up to $300,000 more if it fails to comply with the agreement in the next three years. CVS is also being sued by New York following an investigation that revealed 39 percent of its stores were selling expired items.

Extended Drug Therapy for Hepatitis Challenged
Patients who do not initially respond to standard drug therapy for treatment of hepatitis C are unlikely to respond to long-term maintenance therapy as well, according to a new study. Yet many patients who do not at first respond to drugs are placed on maintenance therapy, which is expensive and can be both physically and psychologically grueling, in hopes that long-term treatment will keep the disease in check. The practice is ineffective and possibly harmful, the study claims.

Cleveland Clinic Discloses Doctors' Ties to Drug Industry
The Cleveland Clinic plans to begin publicly reporting the business relationships that any of its 1,800 staff doctors and scientists have with drug and device makers. The clinic, one of the nation's most prominent medical research centers, is making a complete disclosure of doctors' and researchers' financial ties available on its Web site. It appears to be the first such step by a major medical center to disclose the industry relationships of individual doctors. And it comes as the nation's doctors and hospital are under mounting pressure to address potential financial conflicts of interest that can occur when they work closely with companies to develop and research new drugs and devices.  

Brand-Name Drugs No Better Than Generics
There is no evidence that brand-name drugs given to treat heart and other cardiovascular conditions work any better than their cheaper generic counterparts. Researchers' finding run counter to the perception by some doctors and patients that pricier brand-name drugs are clinically superior. Pharmaceutical companies retain exclusive rights to drugs they develop for a certain number of years, after which others can sell generic versions that are chemically equivalent. The active ingredient is the same, but the color and shape may differ and they may have different inert binders and fillers. 

European Union Accuses Drug Maker of Padding Health Care Costs
The European Union accused drug companies of adding billions of dollars to health care costs by delaying or blocking the sale of less expensive generic medicines. One common tactic was for drug companies to amass patents to protect active ingredients in the medicines, in one case, 1,300 patents for a single drug. Another tactic was for pharmaceutical companies to sue the makers of generic drugs for ostensible patent violations, which tended to delay the availability of the lower-cost products for years. These instances were found during the course of a broad investigation into accusations of anticompetitive practices in the drug sector. The investigation also looked at the complicity of generic drug companies, which had received $200 million from pharmaceutical companies over seven years in exchange for holding their products off the market.  

Nigeria Bans Teething Drug After 25 Children Die
Regulators shut a Nigerian pharmaceutical company and ordered its teething formula pulled from shelves after 25 children who took it died. Nigeria's food and drug administration said that 11 other children were being treated in three states after being given "My Pikin Baby Teething Mixture," which listed paracetemol, or acetaminophen, and an antihistamine agent as ingredients. The afflicted children were stricken with fever, convulsions, diarrhea, vomiting and were unable to urinate. Nigeria has been plagued by tainted, fake or untested drugs since it gained independence from Britain in 1960. 

Johnson & Johnson Gave Money in Return for Positive Drug Studies
Johnson & Johnson gave hundreds of thousands of dollars to a research center run by an influential child psychiatrist explicitly to generate data to help expand sales of the company's antipsychotic drug Risperdal in children. The documents shed a new light on Johnson & Johnson's close relationship with Joseph Biederman, a Harvard University psychiatrist at the center of a controversy involving the dramatic increase in antipsychotic drugs, including Risperdal, prescribed for children, often for unapproved uses. Johnson & Johnson spent at least $700,000 to fund the Johnson & Johnson Center for Pediatric Psychopathology. The purpose of the center as to "generate and disseminate data supporting the use" of Risperdal in children and adolescents.  

Avandia Riskier than Actos for Older Diabetics
Older patients taking GlaxoSmithKline's diabetes drug Avandia had an increased risk of death and heart failure compared with similar patients taking Actos, a competing diabetes drug. The study of about 28,000 patients, all of them older than 65, also concluded that neither drug should be considered very safe. Those who took Avandia had a 15 percent higher rate of death and a 13 percent greater risk of heart failure compared with those taking Actos. 

FDA to Study Phone Number to Report Side Effects
The Food and Drug Administration plans to interview more than 1,500 consumers to decide whether television drug advertisements should urge patients to report side effects. The regulatory agency is considering requiring TV promotions to carry a toll-free number where patients can report serious problems with their medication. However, some critics argue the toll-free number could distract viewers from other important safety information about the drugs. Print advertisements already include contact information for the FDA, but the agency requested more time to complete its work and is expected to soon begin a formal study of the question well over a year after the drug safety legislation was signed into law. 

Millions Unknowingly Taking Unapproved Meds
The government is paying millions for risky medications that have never been reviewed for safety and effectiveness but are still covered under Medicaid. Taxpayers have shelled out at least $200 million since 2004 for such drugs. Yet the Food and Drug Administration says unapproved prescription drugs are a public health problem, and some unapproved medications have been linked to dozens of deaths. Millions of private patients are taking them as well, and their availability may create a false sense of security. Medicaid paid nearly $198 million from 2004 to 2007 for more than 100 unapproved drugs, mostly for common conditions like colds and pain. Medicaid claims that the problem is that the FDA has yet to compile a comprehensive list of unapproved drugs, which allows Medicaid to continue to purchase potentially dangerous medications. 

Radio Host's Drug Company Ties Revealed
An influential psychiatrist who was the host of the popular public radio program "The Infinite Mind" earned at least $1.3 million from 2000 to 2007 giving marketing lectures for drugmakers, income not mentioned on the program. The psychiatrist and radio host is the latest in a series of doctors and researchers whose ties to drugmakers have been uncovered by a senator. The radio host's weekly radio programs often touched on subjects important to the commercial interests of the companies for which he consults. In a program broadcast in 2005, he warned that children with bipolar disorder who were left untreated could suffer brain damage, a controversial view. That same day, the host advocated on behalf of mood stabilizers and was paid $2,500 by GlaxoSmithKline to give a promotional lecture for its mood stabilizer drug, Lamictal. All in all, GlaxoSmithKline paid him more than $329,000 that year for promoting Lamictal. 

Conflicts of Interest May Ensnare Journalists, Too
Health reporters may become entangled in the same kinds of ethical conflicts they often expose when accepting industry-sponsored awards and relying on corporate public relations offices, three researchers warn. Journalism awards consisting of cash prizes and all-expense paid trips given out by drug companies are among the more "astonishing" financial ties between journalists and drug companies. Among the prizes cited are the Embrace Award for reporting on urinary incontinence, consisting of trips to Washington, D.C. and Paris, offered by pharmaceutical firms Eli Lilly and Boehringer Ingelheim, as well as another Eli Lilly award for cancer treatment stories that includes a weeklong international trip for two. The researchers also point a finger at journalism training and education programs sponsored by the health care industry and to professorships funded by drug company grants. The researchers go on to criticize reporters' reliance on drug company press officers for referrals to experts or to patients, whose views may have been carefully screened.  

Roche Ordered to Pay $13 Million to Users of Acne Drug

A jury has ordered drugmaker Roche to pay nearly $13 million to three patients who claim they developed a chronic bowel disorder because of the company's acne drug Accutane. The money will be split among the three Florida residents who filed the lawsuit. Each of the plaintiffs began using Accutane a decade ago to treat teenage acne. One of the plaintiffs is expected to have his colon surgically removed while the others will require long-term drug therapy. The award is the latest stemming from a wave of lawsuits that accuse Roche of downplaying a link between Accutane and inflammatory bowel disease. 

Glaxo Again Accused of Intimidation on Avandia
A Maryland doctor said she felt "threatened and disappointed" after GlaxoSmithKline urged her to stop discussing her concerns that the company's diabetes drug, Avandia, caused heart problems. Her assertion marks the second time that GlaxoSmithKline has been accused of trying to intimidate a researcher who pointed out problems with Avandia, which before its side effects became well-known was the top-selling diabetes drug. Another researcher testified before Congress that GlaxoSmithKline called him a liar and suggested it might sue him if his comments about Avandia's potential safety problems caused the company's stock to drop.  

FDA Panel Splits on Pair of Antibiotics
Federal health advisers backed the benefits of an experimental antibiotic but rebuffed another, questioning whether it would be able to fight dangerous staph infections that are becoming increasingly common. A panel of infection experts assembled by the FDA voted 21 to 5 in favor of the safety and effectiveness of an injectable drug from Theravance, despite concerns it could cause birth defects. Panelists narrowly sided against a similar product from rival Targanta Therapeutics, saying the company's studies were too small and too old to show the drug's effectiveness against some recent bacterial strains. The FDA is reviewing both treatments for patients with hard-to-treat skin infections caused by drug-resistant bacteria. 

Use of Antipsychotics in Children Criticized
Powerful antipsychotic medicines are being used far too cavalierly in children, and federal drug regulators must do more to warn doctors of their substantial risks, a panel of federal drug experts. More than 389,000 children and teenagers were treated last year with Risperdal, one of five popular medicines known as atypical antipsychotics. Of those patients, 240,000 were 12 or younger. In many cases, the drug was prescribed to treat attention deficit disorders. But Risperdal is not approved for attention deficit problems, and its risks, which include substantial weigh gain, metabolic disorders and muscular tics that can be permanent, are too profound to justify its use in treating such disorders.  

FDA Notes Pregnancy Risks with Theravance Drug
Shares of drugmaker Theravance surged after the release of a federal review of the company's experimental antibiotic, despite concerns about the product's risk to pregnant women. Theravance has asked the FDA to approve telavancin for hard-to-treat skin infections caused by gram-positive bacteria, including staph infections. Gram-positives bacteria are highly resistance to many antibiotics now on the market. The FDA delayed a decision on the injectable product last October, asking Theravance to work on manufacturing issues and submit new clinical data. Regulators will be asked about the drug's risks to pregnant women. Early stage studies of the antibiotic linked it to deformations in the offspring of pregnant rabbits, rats and other lab animals.  

A Call for Caution in the Rush to Statins
Judging by recent headlines, you might think it's time to put cholesterol-lowering statin drugs in every medicine cabinet. Heart researchers recently reported that millions of healthy people could benefit from taking statins even if they don't have high cholesterol. Although many doctors hailed the study as a major breakthrough, a closer look at the research suggests that statins are far from magic pills. While they clearly save lives in people with a previous heart attack or other serious heart problems, for an otherwise healthy person the potential benefits remain small.  

Judge Throws Out Paxil Test Case
One of Philadelphia's bellwether cases in litigation over whether the maker of the drug Paxil failed to warn about an increased risk of suicide from its drug has been dismissed following a Common Please Court judge's decision to grant summary judgment on statute of limitations grounds. GlaxoSmithKline has argued that the case could not move forward because of the doctrine of federal pre-emption; however, the judge did agree that the case could not go forward due to the statute of limitations. The suit was filed by the wife and children of a man who had Paxil prescribed to him for stress-related depression. However, the family argued that he was never adequately warned about the risk for suicide from taking the drug. The man later committed suicide.  

FDA Receives 930 Reports of Wrinkle Filler Issues
U.S. regulators have received reports of serious and unexpected problems in people treated with wrinkle-fighting injections known as dermal fillers. The problems included facial palsy, disfigurement and "rare but life-threatening events such as severe allergic reactions and anaphylactic shock." The FDA said it received a total of 930 reports of health problems over the past six months. Many included known complications such as minor swelling. The FDA would not identify which products had reports of more serious problems.  

Unions Accuse CVS Caremark of Pushing Merck Drug
A coalition of labor unions that has been a thorn in the side of CVS Caremark Corp. is accusing the drugstore chain's pharmacy benefits unit of violating the privacy of plan members and trying to get doctors to switch patients to an expensive diabetes drug. At issue is a mailing sent by Caremark and paid for by drugmaker Merck and Co. to doctors who treat Caremark patients with type 2 diabetes. The letter touts Januvia's potential benefits in improving blood sugar control, and suggests doctors may want to consider talking to their patients about using Merck's drug Januvia in addition to their current treatment. The coalition claims the mailings are intrusive and an improper use of CVS Caremark's relationship with its patients.

Painkiller Risk Found for Heart Patients
Heart attack and heart failure patients have a higher risk of a second heart attack or death if they take painkillers, including the generic drug ibuprofen and Celebrex, made by Pfizer, a Danish study has found. Patients who had suffered a heart attack and were taking Vioxx, a painkiller that has been withdrawn from the market, had 2.7 times the risk of having another heart attack or dying compared with patients not taking painkillers. Patients taking Celebrex had double the risk; patients taking the generic diclofenac had 1.9 times the risk, and those taking ibuprofen had 1.3 times the risk, the study found.  

Popular Gas Relief Drops for Infants Recalled
About 12,000 units of Mylicon drops to relieve gas for infants were recalled because some bottles could include pieces of metal. Johnson & Johnson recalled certain bottles of nonstaining Mylicon gas relief dye-free drops. The recalled drops were sold in 1-ounce plastic bottles that were distributed to stores on or around October 5.  

Name-Brand Drug Makers Ruled Liable for Injuries
Drug manufacturers have long had to provide safety warnings for their products. Now they might have to do the same for companies piggybacking on their success. A San Francisco court has ruled that drugmakers can be held liable not only for any harm caused by their own name-brand products, but also for injuries caused by competing companies' generic versions. The judges ruled that "as the foreseeable risk of physical harm runs to users of both name-brand and generic drugs, so too runs the duty of care."

Medical Advances to Alter the FDA
Revolutionary medical advances will force dramatic changes in the ways that drugs are tested and approved and will require pharmaceutical companies to overhaul their businesses, the outgoing head of the Food and Drug Administration has said. Because scientists continue to better understand how someone with a specific genetic makeup will respond to a particular treatment, medicine will soon be able to manage diseases such as cancer so that people live longer, and in some cases, prevent them. The rapid changes in medicine will require the FDA to change its methods. One method that needs to change is the testing of current drug trials. Drug testing will have to focus more on how drugs work in the body and how they interact with people with specific genetic makeups.

China Closes Herbal Drug Firm Linked to Deaths
China, battling to restore trust in its products amid a tainted milk scandal, has closed a local pharmaceutical company whose herbal injections have been linked to the deaths of three people. China last month expanded a product recall for a pharmaceutical company after injections of its products caused adverse reactions in six people, three of whom died. The problem drugs were found to be contaminated with bacteria after being soaked with rain at one of the company's storage areas. Rather than dispose of them, employees repackaged them for sale.  

Officials Seize More Contaminated Heparin
Federal agents seized quantities of a contaminated blood thinner made in China from a small manufacturer in Cincinnati. The blood thinner heparin, given to patients undergoing heart surgery and kidney dialysis, was the focus of a major recall earlier this year after crude drug materials from China were found to be contaminated. Hundreds of frail patients suffered severe allergic reactions and the government received reports of nearly 250 deaths.  

Court Hears Amputee's Case on Limits of Drug Suits
The Bush administration and a drug maker urged the Supreme Court to throw out a multimillion dollar verdict to a Vermont musician who lost her arm because of a botched injection to relieve nausea. A Vermont jury awarded the woman $6.7 million after the improper injection, which led to gangrene and the amputation of her right arm. The jury agreed that Wyeth, the maker of the drug, should have included a stronger warning about the risks of a method of intravenous injection known as IV push. But lawyers for Wyeth and the government said the woman's case should have been thrown out of court because the drug was approved by the FDA and its label adequately warned about its risks. FDA approval serves as a shield against liability lawsuits under state law in such cases.

FDA Warns Bayer on Marketing of Two Aspirins
Aspirin medicines from Bayer intended to promote health hearts and stronger bones are being illegally marketed with unproven health claims, federal regulators said. The Food and Drug Administration scolded the company in two warning letters for never submitting proof that its pills are effective in battling heart disease and osteoporosis. Treatments for those diseases must be reviewed by government scientists and cannot be sold over the counter, the food and drug agency said. Doctors recommend aspirin to treat aches and pains and as a blood thinner for patients with heart disease.

Study: Supplements Useless for Prostate Cancer
The government is stopping part of a major study of whether vitamin E and selenium prevent prostate cancer because the supplements aren't working and there's a hint of risk. More than 35,000 men age 50 and older have been taking one or both supplements or dummy pills as part of a study. But the National Cancer Institute announced that they will be getting letters in the next few days telling them to quit the pills. An early review of the data shows neither supplement, taken alone or together, is preventing prostate cancer. 

Off-Label Meds, Not Placebos, Should be the Real Worry
A newly released study showed that half of all American doctors who responded to a nationwide survey say they regularly prescribe placebos to patients. However, a study in 2001 found that American physicians wrote 150 million prescriptions off-label to treat conditions for reasons other than the ones for which the drugs were approved. That represents 21 percent of all prescriptions written for 160 of the most common medications used in the U.S. About three-quarters of all off-label prescriptions were written for conditions for which there was little or no scientific support to show that they worked. 

Quickly Vetted, Treatment is Offered to Patients
Each year, the FDA permits thousands of medical devices to be sold on the market after only cursory review and with no clear evidence that they help patients. Doctors are free to use those products as they see fit, without telling patients that the devices are not proved. Because the doctors are frequently paid more by Medicare as a way to compensate them for the extra time and expense of adopting new procedures, these unproven products can become widely adopted. FDA officials defend the quick review of medical products as a way to promote innovation and that lengthy study of such devices would be inappropriate and a waste of resources.

Sales of Test for Ovarian Cancer Halted
One of the nation's largest clinical laboratory companies has halted sales of a controversial blood test aimed at early detection of ovarian cancer after receiving a warning from the FDA. The case has raised questions about the degree to which the FDA can or should regulate diagnostic tests. Doctors have long sought a test that could detect ovarian cancer early, when the condition would be more treatable; however, many experts agreed that the current test had never been proven to work. 

Jury Renders Defense Verdict in Diet Drug Case
A Philadelphia jury rendered a defense verdict in one of the last diet drug mass tort cases pending in the Court of Common Please. The plaintiff alleged that his wife's ingestion of diet drug Pondimin, which contained fen-phen, led to her death from primary pulmonary hypertension. Most diet drug cases were disposed of following a global settlement, however 56 cases are still pending, with plaintiffs claiming that diet drugs caused them to develop primary pulmonary hypertension. Many diet drug plaintiffs have been unable to prove they have the condition or that there wasn't an alternative cause to their health problems. 

Half of Doctors Routinely Prescribe Placebos
Half of all American doctors responding to a nationwide survey say they regularly prescribe placebos to patients. The results trouble medical ethicists, who say more research is needed to determine whether doctors must deceive patients in order for placebos to work. The most common placebos the American doctors prescribed were headache pills and vitamins, but a significant number also reported prescribing antibiotics and sedatives. The American Medical Association discourages the use of placebos by doctors when represented as helpful. 

Reports of Serious Drug Reactions Set a Record
The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a new record. The FDA received nearly 21,000 reports of serious drug reactions, including more than 4,800 deaths. Two drugs accounted for a large share of the latest reports. One was heparin, the tainted blood thinner from China that caused an international safety scandal. The other was Chantix, a new kind of anti-smoking drug from Pfizer. Earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams.

$894 Million Deal Ends Pain of Pfizer's Lawsuits
Drug giant Pfizer Inc. has reached an $894 million deal to settle the bulk of the lawsuits over its withdrawn pain reliever Bextra, following the lead of rival Merck & Co., which is spending five times as much to settle Vioxx suits. The Pfizer agreement also would end lawsuits over its popular Celebrex, the only one of the three still on the market. The world's biggest drugmaker said it has agreements in principle to end up to 92 percent of personal injury lawsuits brought by people claiming Bextra and Celebrex caused heart attacks, strokes or other harm.  

Prescription Opiates and Kids: One Pill Can Kill
A recently released report from the nation's poison control centers shows a rising tide of prescription drug use that is threatening unintended users: young children who accidentally ingest the powerful painkillers. Some 9,179 toddlers and kids under age 6 were exposed to widely prescribed drugs such as hydrocodone, oxycodone and methadone between January 2003 and June 2006. Exposures ranged from a pill snatched quickly from a kid's mouth to actual ingestion. Eight children died, 43 suffered life-threatening injuries or serious disabilities and 214 required prolonged medical treatment, all because they mistakenly took strong medications belonging to their parents, grandparents and other adults. 

Access to Experimental Cancer Drug Granted
A critically-ill attorney from Dallas has been granted an experimental cancer-fighting drug, Tysabri. Boston-based Biogen Idec refused the attorney access to the drug, but the Mayo Clinic, working with the Food and Drug Administration, found a legal basis for using Tysabri for the man's treatment. 

Vioxx Risk Lingers At Least One Year After Using Drug
A doubled risk of heart attack, stroke and death persisted at least a year after people stopped taking withdrawn painkiller Vioxx, according to an analysis of long-term data from the study that led drugmaker Merck & Co. to stop selling the drug. The analysis also appears to show the higher risk started soon after patients began taking Vioxx. Doctors critical of Merck and its reporting of Vioxx studies have long argued increased cardiovascular risks from the former blockbuster arthritis drug started after just a few months' use and persisted use ended. Merck continues to insist cardiac risks didn't increase until people took Vioxx for about 18 months, which is its strategy to fight tens of thousands of lawsuits by people claiming harm from Vioxx.

Children Taking Antipsychotics At Risk for Health Problems
The use of powerful antipsychotic medications to treat children and adolescents for mental disorders can lead to dangerous side effects. Researchers compared 4,140 young people treated with antipsychotics to 4,500 children not treated with antipsychotropic drugs. Those taking the drugs were at higher risk of obesity, diabetes, cardiovascular problems, and dizzy spells, a form of hypertension characterized by sudden drops in blood pressure. Most troubling, use of such medications to treat young people has increased substantially over the last decade.

Experts Conclude Pfizer Manipulated Studies
The drugmaker Pfizer earlier this decade manipulated the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses, according to experts who reviewed thousands of company documents for plaintiffs in a lawsuit against the company. Pfizer's tactics included delaying the publication of studies that had found no evidence the drug worked for some other disorders, "spinning" negative data to place it in a more positive light, and bundling negative findings with positive studies to neutralize the results.

Georgia Supreme Court Backs Vaccine Suit in Autism Case
The Supreme Court of Georgia upheld a state appeals court ruling that could open the door to product liability claims against vaccine manufacturers by the parents of autistic children. The Supreme Court found that a suit against manufacturers filed by the parents of an autistic child may go to trial. The ruling conflicts with two federal district courts and state courts in New York and Pennsylvania, which have considered similar suits. Those rulings have held that the federal National Childhood Vaccine Injury Compensation Act of 1986 pre-empts liability claims against companies which product vaccines approved by the FDA if an injury or death resulting from a vaccine's side effects are considered "unavoidable." 

Acetaminophen in Babies May Raise Risks
The use of acetaminophen in the first year of life is associated with an increased risk for asthma, eczema and allergic runny nose later in childhood, a new study reports. Acetaminophen is sold in the United States under the brand name Tylenol and as an ingredient in many other pain relievers. The study found that children given acetaminophen before age 1 had an almost 50 percent increased risk for asthma, eczema and allergy compared with those given none. 

Study Says Drug Samples May Endanger Children
A new study suggests that free drug samples, an effective marketing tool for the drug industry, do little to help the poor and may put children's health at risk. The study asked people how they got health care and if they received free drug samples. It was found that children in the lowest income group were no more likely to receive free samples than were those in the highest income group, in part because the poor are less likely to see doctors. But of greater concern, more than 500,000 children received samples of four medications that were later the subject of serious safety warnings required by the Food and Drug Administration. 

Top Psychiatrist Didn't Report Drug Makers' Pay
One of the nation's most influential psychiatrists earned more than $2.8 million in consulting arrangements with drug makers from 2000 to 2007, failed to report at least $1.2 million of that income to his university and violated federal research rules. The psychiatrist is the most prominent figure to date in a series of disclosures that is shaking the world of academic medicine and seems likely to force broad changes in the relationships between doctors and drug makers.

Cephalon to Pay $431 Million to Settle Whistleblower Suits
To resolve a spate of whistleblower lawsuits, drug manufacturer Cephalon has agreed to pay $431 million in civil and criminal fines for illegally promoting "off-label" uses for three of its drugs. The whistleblower suits accused Cephalon of promoting three of its drugs for uses other than what the Food & Drug Administration had approved. One of the drugs, a powerful pain killer containing fentanyl and only approved for cancer patients, was promoted for the treatment of migraines and general injuries.  

Judge Rejects Commercial Free Speech Defense in 'Off Label' Drug Promotion
A pharmaceutical company sales representative accused of promoting a "powerful sleep-inducing depressant" for "off-label" uses is not entitled to dismissal of the case on free-speech grounds, a judge ruled. Even though such speech is not "inherently" misleading, the judge held that the representative's prosecution for violating the Food, Drug and Cosmetic Act did not amount to an unconstitutional restriction on commercial speech.  

FDA Reviewing Deaths in Anemia Drug Study
Federal health officials are reviewing a higher rate of deaths among patients treated with a Johnson & Johnson anemia drug in a German study of stroke patients. Sixteen percent of patients who were treated with the drug, Eprex, had died three months after the study began, compared with 9 percent who were given a placebo. The study was testing whether Eprex could improve brain function in stroke patients, an unapproved use of the drug.

How to Avoid Drug Errors at Home
Modern medications are a boon to many patients, but sometimes complications of life-saving and life-improving drugs can land people in the hospital. Researchers recently found that of 13,000 patients studied, nearly half of the 714 medication-related cases were judged to be avoidable. Most likely to fall into that category were patients who had impaired cognition, were on multiple medications, and had four or more simultaneous health problems. 

Some See Harm in Hallucinogenic Herb
Salvia divinorum, an ages-old herb once used by Mazatec Indians in Mexico to treat diarrhea and headaches, has recently made a comeback among teens and young adults who smoke the minty plant's dried-up leaves to get a high reportedly similar to LSD. Some are now seeking to ban its use, claiming the herb is dangerous and puts people in an inebriated state where they can't make safe decisions.  

Some Antidepressants May Damage Sperm
Common antidepressant drugs may reduce some men's fetility by damaging the DNA in their sperm, according to scientists. A study of 35 healthy men given paroxetine, sold as Paxil or Seroxat by GlaxoSmithKline, found that on average, the proportion of sperm cells with fragmented DNA rose from 13.8 percent before treatment to 30.3 percent after just four weeks. 

Tylenol May Raise Asthma Risk in Kids
Infants who have been given the common pain reliever paracetamol, also known as acetaminophen, may have a higher risk of developing asthma and eczema by the time they are 6 or 7, a large study covering children in 31 countries has found. The study found that medium use of acetaminophen, widely sold under the brand Tylenol, in the past 12 months increased asthma risk by 61 percent, while high dosages of once a month or more in the past year raised the risk by over three times.  

Drug Label, Maimed Patient and Crucial Test for Justices
In November, the Supreme Court will hear arguments about whether a woman may keep more than $6 million that a Vermont jury ordered Wyeth, a pharmaceutical company, to pay her for failing to warn her adequately about the risks of one of its drugs. The case concerns "pre-emption." a doctrine that can bar injured consumers from suing in state court when the products that hurt them had met federal standards. 

Ancient, But How Safe?
A recent report found that nearly 21 percent of 193 ayurvedic herbal supplements bought online, produced in both India and the United States, contained lead, mercury or arsenic. No one knows the exact numbers of arsenic, mercury or lead poisoning illnesses in the United States related to ayurvedic medicine, but the Centers for Disease Control and Prevention reported a total of 12 cases of lead poisoning associated with ayurvedic products in 2005.

Experts See No Link Between Vaccines and Autism
A doctor at Children's Hospital of Philadelphia has been defending the safety of vaccines for children for years in response to beliefs that they are tied to autism-related disorders. He continues in the same vein with his new book, which is already generating heat, Autism's False Prophets: Bad Science, Risky Medicine and the Search for a Cure.

Imports from Indian Drug Maker Halted
The government blocked the importation of more than 30 generic drugs, including popular antibiotics and cholesterol medicines, made by India's biggest pharmaceutical company, citing poor quality in two of its factories. Inspections by the Food and Drug Administration earlier this year found violations that could lead to contamination, allergic reactions and other problems, and the company has failed to take proper steps to correct them.

Old Meds? Many Get Conflicting Disposal Advice
American consumers know not to toss old car batteries in the trash or pour motor oil down the drain, but those who want to get rid of unused drugs face a barrage of conflicting guidance: flush, don't flush, toss in trash, don't toss in trash. Often, there's no information at all. The most likely source of guidance should be the instructions packaged with prescription drugs, or advice dispensed by a pharmacist or doctor. But hundreds of instructions provided with prescription medications found that Americans are almost never told how to safely dispose of unwanted drugs, despite mounting evidence that medications flushed down the toilet damage the environment and eventually reach drinking water supplies.  

Risks Found for Youths in New Antipsychotics
A new government study has found that the medicines most often prescribed for schizophrenia in children and adolescents are no more effective than older, less expensive drugs and are more likely to cause some harmful side effects. The standards for treating the disorder should be changed to include some older medications that have fallen out of use. The results are likely to alter treatment for an estimated one million children and teenagers with schizophrenia and to intensify a broader controversy in child psychiatry over the newer medications.

46 Million in U.S. Have Drugs in Drinking Water
Testing of America's drinking water supplies have shown that more American's are affected by trace pharmaceuticals in the water than previously thought. At least 46 million Americans are exposed to drug-contaminated drinking water supplies. Among the drugs found in drinking water were cholesterol medication, nicotine derivatives, anti-convulsant carbamezepine, tranquilizers and hormones.

Judge Rules Product Liability Suit Pre-empted by Federal Vaccine Act
A Philadelphia judge ruled that a federal law governing the liability of pharmaceutical companies for drug vaccines pre-empts state tort claims of design defect and failure to warn in the products liability case of an 11-year-old boy who has autism. The judge ruled that both the plaintiffs' design defect and failure to warn claims were expressly pre-empted by the federal National Childhood Vaccine Injury Act. The plaintiffs had argued that the defendants were negligent because the public and the medical profession were not warned about the alleged hazards of mercury in the vaccines.  

Ibuprofen May Complicate Prostate Screening
Taking a popular class of pain relievers that includes aspirin and ibuprofen lowers the levels of a protein in a man's blood that doctors use to screen for prostate cancer. The researchers said it is unclear whether this means these men have a lower risk for developing prostate cancer or these medications may make it harder to detect prostate tumors with a common screening test. The study found that those who took nonsteroidal anti-inflammatory drugs nearly every day had prostate specific antigen, or PSA, levels about 10 percent lower than men who did not take them. PSA is a protein produced by cells in the prostate gland, and elevated levels in the bloodstream may indicate the presence of prostate cancer or other prostate conditions.

Judge to Unseal Documents on Eli Lilly Drug Zyprexa
A federal judge decided to unseal confidential materials about Eli Lilly's top-selling antipsychotic drug Zyprexa, citing "the health of hundreds of thousands of people" and "fundamental questions" about the way drugs are approved for use. The decision came as part of a ruling that gave class-action status to a case brought by insurance companies, pension funds and unions that want Lilly to repay them billions of dollars they spent on the drug. They contend that Lilly hid the side effects of the drug and marketed it for unapproved uses. 

Autism and Measles Vaccine Link Further Debunked
New research further debunks any link between measles vaccines and autism, work that comes as the nation is experiencing a surge in measles cases fueled by children left unvaccinated. Years of research with the measles, mumps and rubella vaccine, better known as MMR, have concluded that it doesn't cause autism. Still, some parents' fears persist, in part because of one 1998 study that linked the vaccine with a subgroup of autistic children who also have serious gastrointestinal problems. That study reported that measles virus was lingering in the children's bowels. 

Federal Judge Green-Lights Paxil Suit Over Teen's Suicide
The family of a teenager who committed suicide in 2002 after taking the antidepressant drug Paxil is not barred from suing the manufacturer, because the Food and Drug Administration had not yet taken any position on whether there was a link between the use of such drugs by pediatric patients and an increased risk of suicidality, a federal judge has ruled. The judge concluded that a jury must decide whether the drug manufacturer "indeed possessed information, not available to the FDA, upon which it could have unilaterally added a warning to its labeling."

For Widely Used Drug, Question of Usefulness Still Lingers
When the Food and Drug Administration approved a new type of cholesterol-lowering medicine in 2002, it did so on the basis of a handful of clinical trials covering a total of 3,900 patients. None of the patients took the medicine for more than 12 weeks, and the trials offered no evidence that it had reduced heart attacks or cardiovascular disease, the goal of any cholesterol drug. The lack of evidence has not stopped doctors from heavily prescribing that drug, whether in a stand-alone form sold as Zetia or as a combination medicine called Vytorin. Currently, more than 3 million people worldwide take either drug every day.  

Doubts Grow Over Flu Vaccine in Elderly
The influenza vaccine, which has been strongly recommended for people over 65 for more than four decades, is losing its reputation as an effective way to ward off the virus in the elderly. A growing number of immunologists and epidemiologists say the vaccine probably does not work very well for people over 70, the group that accounts for three-fourths of all flu deaths. A recent study has reignited the longstanding debate over claims that the vaccine prevents thousands of hospitalizations and deaths in older people.

Amgen Alters Anemia Drug Discounts
Amgen is halting some pricing practices that critics say were contributing to overuse of its flagship anemia drug Aranesp at a time of mounting concerns about the product's safety. Amgen confirmed that it would no longer offer rebates to oncology clinics for their use of Aranesp, although it said it would offer larger discounts at the time of purchase. Critics have said that by providing hundreds of millions of dollars in discounts and rebates each year to cancer clinics, Amgen provided an incentive for doctors to use more of the drug. 

Stanford to Limit Drug Maker Financing
Stanford University, concerned about the influence drug companies may have on medical education, is expected to announce that it will severely restrict industry financing of doctors' continuing education at its medical school. Standford plans to no longer let drug and device companies specify which courses they wish to finance. Instead, companies will be asked to contribute only to a schoolwide pool of money that can be used for any class, even ones that never mention a company's products. 

U.S. Probes Possible Vytorin Link to Cancer
U.S government drug safety regulators are investigating whether the cholesterol-lowering drug Vytorin can increase patients' risk of developing cancer. However, the Food and Drug Administration said patients should not stop taking Vytorin because the evidence of a cancer link is unclear. While one recent clinical trial indicated higher rates of cancer for patients taking the medication, two studies currently under way have shown no increased risk. 

PharmaCare Charged with Dealing in Stolen Property
Federal prosecutors charge that PharmaCare Health Services bought and sold approximately $7.9 million of stolen over-the-counter medications and health and beauty aids, which had not been legitimately obtained. The IRS and other agencies busted a shoplifting ring that was allegedly run by two brothers who marketed the stolen medications and other drugstore products. 

Researchers Question Wide Use of HPV Vaccines
Two vaccines against cervical cancer are being widely used without sufficient evidence about whether they are worth their high cost or even whether they will effectively stop women from getting the disease. Both vaccines target the human papillomavirus, a common sexually transmitted virus that usually causes no symptoms and is cleared by the immune system, but which can in very rare cases become chronic and cause cervical cancer. 

Clinical Trial Touches Off Drug Access Fight
Lawyers for a Minnesota family suing to gain access to an experimental muscular dystrophy drug for their 16-year-old son argued that a drug company led them to believe he could participate in a clinical trial but then went back on its word. The dispute centers around a clinical trial that the drugmakers promised the boy would not have to be involved in to receive the drug. However, now the drugmaker is refusing to give the boy the medication. 

Three Executives Plead Guilty to Selling Prescription Drugs Online
A Georgia company that manufactures herbal nutritional supplements and three of its executives have pleaded guilty to conspiracy and fraud charges for illegally selling generic prescription drugs over the Internet. The company and its executives were accused of conspiring to import and distribute adulterated, mislabeled and unapproved new drugs and of committing mail and wire fraud. 

Stronger Label Sought for Diabetes Drug Byetta
Federal regulators are working on a stronger label for a widely used diabetes drug after deaths continue to be reported despite earlier government warnings. The FDA said it received six new reports of patients developing a dangerous form of pancreatitis while taking the drug Byetta. Two of those patients died and four are still recovering. The recent FDA report updates an earlier report of 30 Byetta patients who developed the ailment.

Methadone Rises as a Painkiller with Big Risks
Methadone, once used mainly in addiction treatment centers to replace heroin, is today being given out by family doctors, osteopaths and nurse practitioners for throbbing backs, joint injuries and a host of other severe pains. A synthetic form of opium, it is cheap and long lasting, a powerful pain reliever that has helped million. But because it is also abused by thrill seekers and badly prescribed by doctors unfamiliar with its risks, methadone is now the fastest growing cause of narcotic deaths. It is implicated in more than twice as many deaths as heroin, and is rivaling or surpassing the tolls of painkillers like OxyContin and Vicodin. 

Popping Antibiotics Send Thousands to ER
Bad reactions to antibiotics, mostly allergic ones, send people to U.S. emergency rooms more than 140,000 times each year. The findings offer another reason for doctors to limit their use of the drugs, which are overused in the United States, claim the Centers for Disease Control and Prevention.  

FDA Warns of Reactions to Anti-Alcohol Drug
Nearly 200 patients given the drug Vivitrol for alcohol dependence reported complications from the injection, including abscesses requiring surgical drainage. The FDA received 196 reports of patients who were given Vivitrol and developed swelling, pain, bleeding and other complications, sixteen of whom required surgery. 

Heart Drug Combo May Harm Muscles
U.S. health officials warned the public about the risk of a rare type of muscle injury seen when the cholesterol drug simvastatin is combined with the anti-arrhythmia medicine amiodarone. The FDA said it continued to receive reports of rhabdomyolysis, a type of muscle injury that can lead to kidney failure or death, despite a 2002 warning about the drugs.  

Drug Price Hikes Draw Scrutiny from Lawmakers
Pharmaceutical companies are increasingly hiking the prices of specialty medications by 100 percent or more, attracting scrutiny from lawmakers who have pledged to lower health care costs. Drug prices have historically outpaced those of other consumer goods, with the average price of medicines most-often prescribed to seniors rising 7.4 percent last year.

10 Infant Deaths in Arizona Tied to Cold Meds
At least 10 infant deaths in Arizona in 2006 were linked to over-the-counter cough and cold remedies, underscoring the danger of giving the medications to children younger than 2. Investigators found that of 21 infants who died unexpectedly and had autopsy data available, 10 had evidence that they had been given cough or cold medication shortly before they died.

Abbott Faces More Litigation Over AIDS Drug
When Abbott Laboratories increased the price of its popular AIDS drug by 400 percent in 2003, it initiated several antitrust lawsuits. The lawsuits accuse Abbott of raising the price of the HIV-fighting Norvir to illegally stifle competition and boost sales of its own alternative, Kaletra. Embarrassing internal communications between executives plotting how to thwart their rivals in the lucrative HIV drug cocktail market have been made public in the process. One case has been settled when Abbott agreed to pay between $10 million and $275 million to charities.  

Setback for Anesthesia Drug
The Schering-Plough Corporation said that regulators had rejected its drug that reverses the effects of anesthesia. The Food and Drug Administration issued a "not approachable" letter for the medicine, citing concerns related to hypersensitivity and allergic reactions to the product.

 

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