FDA Advisors OK Disputed Pain Relievers
WASHINGTON — A Food and Drug Administration advisory panel voted Friday to let doctors prescribe Cox-2 painkillers, including Celebrex and Vioxx, but recommended stronger warnings about the risk of heart attacks and strokes.
Doctors, scientists and other experts on the 32-member panel overwhelmingly agreed that Cox-2 inhibitors -- hailed as a breakthrough in treating severe arthritis pain when they first won FDA approval -- all significantly increased the risk of cardiovascular problems in patients.
The panel proposed that Celebrex, Vioxx and Bextra, the third Cox-2 drug cleared by the FDA, carry "black box" warnings -- the strongest admonishment the FDA can give to doctors. Such warnings are likely to discourage use of the drugs.
The panel's decisions, made during three days of hearings and deliberations, sought to balance the health risks against the benefits the drugs provide to tens of millions who take them. In what amounted to a series of split verdicts, panel members divided over the risks posed by individual drugs in the Cox-2 inhibitor group.
In the case of Vioxx -- which was taken off the market voluntarily last fall by its maker, Merck, after a company-sponsored study confirmed the dangers -- panel members voted to approve its use by a margin of two votes.
The FDA, which has pledged prompt regulatory action on the panel recommendations, likely will have to tailor different responses to each of the three drugs. The agency typically follows its panels' recommendations.
Beyond the effect of its decisions on patients and on billions of dollars in revenues for drug makers, the blue-ribbon panel was widely seen as a test of the FDA's readiness to deal with problems that had embroiled the agency in controversy for more than a year.
Comprised of two FDA advisory committees, the panel was convened in response to evidence of weaknesses in the FDA's system for monitoring the safety of drugs after it had approved them for market.
In particular, critics had charged, the FDA was too slow and too dependent on self-reporting by manufacturers when it came to problems that emerged once huge numbers of people began using the drugs.
A leading FDA congressional critic, Sen. Charles E. Grassley (R-Iowa) said Friday: "The joint advisory committee meetings this week were valuable for their transparency and respect for the scientific process."
