FDA begins hearing on COX-2 drugs
The FDA kicked off the first of three days of advisory committee hearings today probing the safety of COX-2 drugs.
Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, promised prompt action, saying the agency will make a decision in the next few weeks based on the committees' recommendations. The FDA is not required to accept such recommendations, but generally does.
Galson also reminded the group that COX-2s are important painkillers used widely by people in chronic pain and that it is important to balance the drugs' risks with their benefits.
The committees will hear from government officials, physicians, researchers and the public before voting on recommendations for COX-2s.
The FDA has been criticized for being slow to recognize problems with COX-2s after clinical studies showed an increased risk of heart attack and stroke in users of Merck's Vioxx and Pfizer's Celebrex and Bextra.
Merck voluntarily withdrew Vioxx in September. Celebrex and Bextra remain on the market.