FDA PANEL OPENS DOOR FOR RETURN OF VIOXX

A Food and Drug Administration expert advisory panel
narrowly voted 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. 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." 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.
http://www.washingtonpost.com/wp-dyn/articles/A34803-2005Feb18.html