Vioxx

Merck has agreed to pay more than $650 million to settle two whistleblower suits, the U.S. Justice Department has announced. One of the suits claimed that the pharma paid providers to use its... Read more...

For every regulatory action, it seems that there must be a backlash. This time, it's a move by consumers to bring back the controversial drug, Vioxx. Patients who once depended on the drug for... Read more...

With dangers from antidepressant use in children, Read more...

On the one hand, everyone would like to see potentially beneficial drugs approved as soon as possible. On the other, no one wants to see the FDA speed heedlessly through the approval process either. As scandals blow up on Capitol Hill over Avandia and other drugs, critics are beginning to question whether the FDA is striking the right balance between speed and safety. Evidence increasingly suggests that the FDA has a habit of silencing internal and external critics--and that safety may be …

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A new bill being considered by Congress would ban pharmaceutical companies from advertising new drugs for two years after they hit the market. Legislators have said they want to make sure drugs are safe before the pharmas begin aggressive marketing. Senators Ted Kennedy (D-MA) and Michael Enzi (R-WY) began working on the measure in 2004 after the Vioxx debacle. The new bill would expand the FDA's powers over drug launches, including a provision allowing it to impose the new ban. Pharmas …

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Some say that if outside researchers had access to drug safety data, disasters like the Vioxx scandal might have been avoided. At present, however, the FDA doesn't let outsiders see clinical trial data unless forced to do so. This secrecy can only do harm, suggests a new commentary in Health Affairs. Report

Still stinging from its troubles with Vioxx and approved antidepressants that raise suicidal thinking in some teens, the FDA is ready to pay more attention to post-approval drugs. The agency has decided to institute a pilot program under which it will track the way drugs work after they've been on the market for about 18 months. However, it will probably take a year before the program actually kicks off, according to Dr. Steven Galson, director of the agency's drug center. As part of the …

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A California court declared a mistrial in two Vioxx liability lawsuits against drugmaker Merck after the jury deadlocked on whether the plaintiffs' physicians would have recognized the potential risks or side-effects of taking the painkiller. Attorneys for both plaintiffs, Lawrence Appell, of Scottsdale, AZ and Rudolph Arrigale, of Westminster, CA said they would seek a new trial. Report

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In a vote that expressed strong disagreement over the long-term consequences, an FDA panel has recommended that Pfizer be allowed to market painkiller Celebrex for treatment of children two and older with juvenile rheumatoid arthritis. The fifteen-member advisory board ruled that for short-term use, the benefits of the drug outweighed its risks, despite concerns over past cardiovascular problems caused by sister drugs like Vioxx. However, in a separate 8-7 decision, it found that Pfizer …

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Drugmaker Pfizer is seeking permission to sell painkiller Celebrex to children as young as two years old with arthritis. According to the FDA, about 1 in 1,000 children have juvenile rheumatoid arthritis. Some physicians already prescribe Celebrex, given that other drugs make them sick to their stomach. Still, Pfizer's move is controversial, particularly given that critics are already calling for the drug's removal from the market. Celebrex is the last cox-2 inhibitor to remain on the …

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