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 See: FDA Announces Changes For All NSAIDs; Bextra Withdrawn From Market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 17, 2005
Meeting Underway
The joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, being held by the U.S. Food an Drug Administration, is underway (February 16-18, 2005). The testimony of drugmakers and medical experts at these hearings is of particular interest to patients who have been taking any of the medications in the class of arthritis drugs known as COX-2 selective inhibitors. Vioxx (rofecoxib) was voluntarily withdrawn from the market by its maufacturer Merck on September 30, 2004 after studies showed a higher risk of cardiovascular problems.
Since then, Celebrex (celecoxib) and Bextra (valdecoxib) have also been under scrutiny, as well as two other COX-2 selective inhibitors still seeking FDA approval, Prexige (lumiracoxib) and Arcoxia (etoricoxib).
The NSAID (non-steroidal anti-inflammatory drug) Mobic (meloxicam) which until now seems to have skirted much of the controversy, has also demonstrated a higher heart risk in one study. The information about Mobic, just revealed by a veteran U.S. FDA scientist at the meeting, is from a new, yet-to-be published study.
The risk versus benefit of the COX-2 selective inhibitors is the focus of the 3-day meeting. Will it be determined that risk outweighs benefit and will the entire class of COX-2 selective inhibitors be pulled from the market? Will they find that the benefit outweighs risk for the majority of arthritis patients and keep one or more COX-2 selective inhibitors on the market? Will additional warning labels be the recommendation deemed sufficient? Should the risk versus benefit issue stay between an individual patient and his/her doctor?
What Were The Final Recommendations Of The Panel?
Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, reportedly 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: Merck May Consider Selling Vioxx Again, ABCNEWS.com, 2/17/05; Pain Drug Mobic Shows Increased Risk - FDA Scientist, Reuters UK, 2/17/05; Medical Panel Poses Pointed Questions to Drug Makers Over Risks of Painkillers, by Gardiner Harris, New York Times, 2/17/05; Cox-2 Drugs Take Center Stage at Government Hearings, MedicineNet, 2/16/05
First published: 2/17/2005
