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FDA Panel Opens Door For Return Of Vioxx

Many Advisers Urge New Restrictions on Painkillers

By Marc Kaufman
Washington Post Staff Writer
Saturday, February 19, 2005; Page A01

A Food and Drug Administration expert advisory panel narrowly voted yesterday in favor of allowing the arthritis painkiller Vioxx back on the market under strict conditions. The committee also voted in favor of allowing Celebrex and other drugs in the COX-2 class to remain available.

But a substantial majority of the 32-member panel recommended steps to significantly restrict their use and called for extensive new testing of similar arthritis drugs on, or coming to, the market.

Chairman Alastair J.J. Wood, right, and other members of the advisory committee listen to testimony. Wood said issues surrounding the drugs are "extremely complex." (Mark Wilson -- Getty Images)

_____From the Post_____
Vioxx Alternative Potentially as Risky, Official Says (The Washington Post, Feb 18, 2005)
FDA Panel Mulls Whether All COX-2 Drugs Have Same Risk (The Washington Post, Feb 17, 2005)
FDA Plans New Board To Monitor Drug Safety (The Washington Post, Feb 16, 2005)

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The proposed restrictions include a ban on direct-to-consumer advertising, the inclusion of a strong warning in a highlighted black box on the bottle label or box, and a requirement that patients be given a written warning that the drugs increase the risk of heart attacks and strokes. Some members also said the drugs should be used only when other medications have failed.

The panel's message, Chairman Alastair J.J. Wood said, is that issues raised by the COX-2 drugs are "extremely complex" and that "there are no black-and-white answers." But he said that although the group clearly believes drugs used to treat chronic pain are valuable, the drugs need substantially more testing and should not be aggressively advertised, as they had been until last fall.

Although the votes supported controlled marketing of the drugs, the sometimes sharply divided panel hardly gave them a vote of confidence. The votes came only after the advisory group agreed unanimously that COX-2 inhibitor drugs "significantly increase" the risk of heart attacks and strokes.

The FDA usually follows advisory panels' recommendations but is not bound by them. The agency is expected to make its decisions within weeks.

Celebrex and Vioxx were approved in the late 1990s and were aggressively advertised as breakthrough treatments for arthritis. Millions of patients began taking them, although studies have shown that many were not at risk for the gastrointestinal problems sometimes caused by older painkillers, which the newer drugs were designed to avoid.

In addition to voting on whether the COX-2 drugs should remain available to U.S. consumers, the panel was asked to assess the safety of nonsteroidal anti-inflammatory drugs such as Mobic and ibuprofen. The group overwhelmingly recommended that they, too, carry new warnings, although there was a consensus that some of them -- naproxen in particular -- are much safer than others. (Ibuprofen is sold as a generic drug and by the brand names Advil and Motrin; naproxen is sold under brand names including Aleve and Naprosyn.)

Just before the voting began, Wood told the group that it was struggling with the biggest and most complicated drug safety issue to come before the FDA. He said that of the 16 drugs the FDA has taken off the market, none had affected nearly as many people because they involved relatively rare side effects and not a general cardiovascular threat.

The vote to allow Merck & Co.'s Vioxx back on the market was 17 to 15. Vioxx was withdrawn in September, and significant obstacles remain to any return to pharmacy shelves.

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