Editor note: On April 7, 2005, following scrutiny of the class of arthritis drugs known as NSAIDs and COX-2 inhibitors, the FDA announced planned regulatory actions. Pfizer was asked to withdraw Bextra from the market by the FDA. See: FDA Announces Changes For All NSAIDs; Bextra Withdrawn From Market
Dateline: February 18, 2005
Panel Says COX-2 Drugs Should Stay On Market
U.S. FDA panelists voted to allow sales of Vioxx (rofecoxib), Celebrex (celecoxib), and Bextra (valdecoxib) while at the same time acknowledging the COX-2 drugs pose risks for heart problems. After weighing the issue of benefits versus risks, the panel concluded that the benefits outweigh possible risks to consumers and the COX-2 drugs should remain available to people who need them.
The Vote
Panelists voted overwhelmingly to keep Celebrex on the market, but the vote was closer for Vioxx and Bextra. The vote to keep the drugs on the market was:
Panelists unanimously agreed COX-2 drugs, also known as COX-2 selective inhibitors, pose a risk of heart trouble but voted to keep them on the market to ensure the drugs are available for people who really need them. For other people, COX-2 drugs may be inappropriate and there may be better choices.
The risk from Celebrex varied in different studies. The panel was informed that no cardiovascular problems were seen at the normal dose of 200 mgs. Heart problems appear in a colon polyp study by patients who were taking 400 mg. Celebrex.
The side effects in question including heart attacks, stroke, and irregular heartbeat, are not rare and therefore are hard to definitively attribute to COX-2 drugs. There is data which is not available which would be useful, such as the effect on blood pressure.
Panel Recommendations
New and larger studies may be indicated. Other suggestions from the panel included:
- Possible restrictions on the drugs such as a black box warning
- More patient information with the drugs
- Possible restrictions for who could get the drugs
- Possible ban on direct-to-consumer advertising
Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, has reportedly previously stated, that the agency will act rapidly in the next several weeks on the committee's recommendations. The FDA, though not required to, usually follows recommendations from the advisory panel.
Related Resources
Sources: Associated Press, ABCNEWS.com, MSNBC, CNN
First published: February 18, 2005
