Vioxx Woes Raise New Questions About Approval ProcessOct 3, 2004 | AP
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Americans should feel reasonably safe taking government- approved prescription drugs with a few caveats even after a popular arthritis medication was pulled from the market, medical experts say.
Vioxx was the first prescription drug since 2001 to be taken off the market for safety reasons. Its maker, Merck & Co., cited an increased risk of heart attack and stroke.
The withdrawal Thursday came just weeks after the company defended the safety of the drug, which accounted for $2.5 billion in worldwide sales in 2003, and the Food and Drug Administration approved the use of Vioxx in children as young as 2.
The problems with Vioxx raise questions about the agency's safety review process and the length of time it took Merck to pull the drug, observers say.
''No drug is fully safe,'' Crystal Rice, an FDA spokeswoman, said in an e-mail. ''Our job is to appropriately balance our decisions, based on the risk-benefit profile for a drug and the societal need and desire for new drugs. We believe that our actions regarding Vioxx were appropriate and consistent with our public health mission.''
The FDA is under intense pressure from the industry and elsewhere to approve drugs more quickly, despite clinical trials that some say enroll too few patients and for too short a time for worrisome side effects to surface.
An agency spokeswoman, Kathleen Quinn, said the FDA gets ''pressure from all sides allegations that we're too fast, too slow. We make decisions on the basis of the science. We weigh the benefits against the risks and we make the tough calls.''