January 17, 2004
The Food and Drug Administration has taken the first step towards determining whether COX-2 inhibitors, like Vioxx, Celebrex and Bextra, are cleared of suspected health risks or banned from the marketplace.
The agency has announced a joint public meeting of the agency's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to be held February 16, 17 and 18, 2005.
The committees will discuss the overall benefit-to-risk considerations, including cardiovascular and gastrointestinal concerns, for COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) and related medicines. The main health issue, however, is whether taking COX2 drugs has side effects so serious they outweigh the drugs' benefit in most patients.
The issue first arose in last September, when Merck voluntarily withdrew its arthritis pain-reliever Vioxx from the market. Merck said studies suggested prolonged use of the COX-2 drug made patients more vulnerable to death by heart attack or stroke. Pfizer has since been named in numerous lawsuits by former Vioxx users.
In December, Pfizer, the maker of Celebrex, another COX-2 drug, announced that clinical trials using Celebrex had been suspended because of similar concerns. Though it suspended advertising for Celebrex, Pfizer said it had no plans to withdraw it from the market.
The FDA said members of the public are encouraged to participate in next month's session. It said interested persons may present data, information or views, orally or in writing, on issues pending before the committees.
Oral presentations from the public will be scheduled between 1:00 p.m. and 3:00 p.m. on February 17. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should register to speak at the meeting before February 4, 2005. No registration is required for those only planning on attending the meeting.
The three-day meeting will be held at the Hilton Washington DC North, 620 Perry Parkway, Gaithersburg, Md. The proceedings will start at 8:00 a.m. each day. Agendas and other background materials will be posted online no later than one business day before the meeting.
