FDA Panel: Vioxx Should Be Available Despite Risks
Advisers Say Benefits Of Arthritis Drugs Outweigh Risks
POSTED: 9:46 am EST February 18,
2005
UPDATED: 6:50 pm EST February 18,
2005
WASHINGTON -- Food and Drug Administration advisers have concluded that Vioxx poses heart risks, but that it should be allowed to be sold. The decision came Friday after similar findings on two other drugs, Bextra and Celebrex. The advisers recommended that the painkillers remain on the market, despite higher risks of heart problems from using them. They said the benefits outweigh the risks.
The FDA is not required to follow the advisory committees' recommendations, but it usually does.The drugs are known as Cox-2 inhibitors. Merck & Co. pulled Vioxx from the market in September because of reported heart problems and strokes in users. Celebrex and Bextra, both made by Pfizer, remain on the market.The FDA's arthritis and drug safety advisory committees are concluding three days of meetings to assess risks of the three popular painkillers.The advisory panels were the most divided over Vioxx, voting 17-16 in favor of making it available. On Bextra, the vote was 17-13, with two abstaining. The vote for Celebrex was nearly unanimous.The panelists suggested restrictions on the drugs such as placing a severe warning on them, including more patient information with the drugs, restricting which patients get the drugs and possibly banning direct-to-consumer advertising for the products.In the case of Celebrex, the panel was told that no cardiovascular problems were seen at the normal prescription dose of 200 milligrams. Heart trouble began to appear in study patients who took 400 milligrams. The excess risk from Celebrex varied in different studies and the panel didn't seek to determine just how much more hazard a user faces than someone on another drug.Earlier, an FDA official said a large new study on Vioxx and other painkillers may be necessary.Dr. Robert Temple told the committees Friday that "the idea of doing a large new study has weight." And he raised the possibility that such a study would go beyond the Cox-2 drugs to include such widely used painkillers as ibuprofen, naproxen and diclofenac.
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Video: The FDA is not required to follow the advisory committees' recommendations, but it usually does.The drugs are known as Cox-2 inhibitors. Merck & Co. pulled Vioxx from the market in September because of reported heart problems and strokes in users. Celebrex and Bextra, both made by Pfizer, remain on the market.The FDA's arthritis and drug safety advisory committees are concluding three days of meetings to assess risks of the three popular painkillers.The advisory panels were the most divided over Vioxx, voting 17-16 in favor of making it available. On Bextra, the vote was 17-13, with two abstaining. The vote for Celebrex was nearly unanimous.The panelists suggested restrictions on the drugs such as placing a severe warning on them, including more patient information with the drugs, restricting which patients get the drugs and possibly banning direct-to-consumer advertising for the products.In the case of Celebrex, the panel was told that no cardiovascular problems were seen at the normal prescription dose of 200 milligrams. Heart trouble began to appear in study patients who took 400 milligrams. The excess risk from Celebrex varied in different studies and the panel didn't seek to determine just how much more hazard a user faces than someone on another drug.Earlier, an FDA official said a large new study on Vioxx and other painkillers may be necessary.Dr. Robert Temple told the committees Friday that "the idea of doing a large new study has weight." And he raised the possibility that such a study would go beyond the Cox-2 drugs to include such widely used painkillers as ibuprofen, naproxen and diclofenac.
More Information: FDA Meeting On Arthritis Drug Safety Previous Stories:
- February 17, 2005: Army Doctor: Soldiers Need Vioxx, Similar Drugs
- February 16, 2005: Official: Vioxx Regulators Were Not 'Asleep At The Wheel'
- February 14, 2005: Vioxx, Celebrex, Bextra Linked To Cardiovascular Risks
- February 7, 2005: Report: Merck Panel Saw Early Problems With Vioxx
- February 1, 2005: New Data Prompts Renewed Call For Celebrex Ban
- January 31, 2005: Kaiser To Stop Dispensing Painkiller Bextra
- January 24, 2005: Researchers: Merck Discredited Initial Vioxx Findings
- December 23, 2004: FDA Launches Review Of Celebrex, Similar Drugs
- December 10, 2004: FDA Strengthens Warnings About Bextra
- October 7, 2004: Vioxx May Not Be Only Drug With Heart Risk
- September 30, 2004: Arthritis Patients Scramble For Alternatives Amid Vioxx Recall
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