Summary

Original source:
http://seattlepi.nwsource.com/national/apscience_story.asp?category=1500&slug=FDA%20Drug%20Safety

Details

• On Thursday, Merck announced it was withdrawing its drug, Vioxx, because of health concerns.
• 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.
• But the problems with Vioxx raise questions about the Food and Drug Administration's safety review process and the length of time it took Merck to pull the drug, observers 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 in people who used the medication.
• The withdrawal on 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 FDA approved the use of Vioxx in children as young as 2 years old.
• The FDA has come 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.
• "I fear that FDA has gotten a little bit too cowed by industry demands to function as a good regulator," said Avorn, an associate professor of medicine at Harvard Medical School who is affiliated with Brigham and Women's Hospital in Boston.
• "The FDA is not going to hold up a medication for a generation to make sure it's safe.
• And similarly, they're not going to require you to study half a million people," Ray said.
• "There is no provision for systematically assessing and reviewing the safety of the many, many medications that are out there," Ray said.

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