Secret FDA Avandia Vote Outrages Senator--Begs Questions on Procedure
October 31, 2007, New York, NY— A high-ranking Republican Senator has learned
that an internal panel of government safety experts recently voted in a private
meeting to keep Type 2 diabetes drug Avandia on the market by a sliver-thin
margin of 8-7. Sen. Charles Grassley of Iowa wants answers to why the Food and
Drug Administration’s Drug Safety Oversight Board (DSOB) did not disclose this
vote to the public, which took place on October 2, 2007, according to
Reuters.
“This is yet another example of how patients are kept in the
dark about how close a pharmaceutical comes to being withdrawn from the market,”
said Arthur Luxenberg, partner of personal injury law firm Weitz &
Luxenberg, P.C. “Both the FDA and GlaxoSmithKline had an obligation to fully
inform the public of Avandia’s heart risks. There are growing questions about
who knew what and when.”
The public at large only learned of Avandia’s
link to a significant increase in the risk of heart attack in June 2007, after
the New England Journal of Medicine published that finding in a combined
analysis of more than 40 studies.
Following that report, the FDA
announced in June that the toughest so-called “black-box warning” label would be
placed on Avandia for its link to heart failure. This move was overshadowed,
however, by the discovery that FDA safety reviewers reportedly recommended
taking that urgent step more than a year earlier. The FDA is currently weighing
whether to add a separate warning label for heart attack, according to the Wall
Street Journal. This label would hobble GlaxoSmithKline’s contention that
Avandia is just as safe as its competitors. Its leading drug rival, Actos, does
not have a warning for heart-attack risk.
If you or a loved one has
suffered cardiac complications after ingesting Avandia, you deserve the guidance
of a knowledgeable drug attorney. Get a free case review by filling out the form
below.
see also:
Senators Testify
Senators Testify in Investigation That FDA Pulled Reviewer off AvandiaAvandia Scientist Says in Investigation that the FDA Removed Him
Updated Study, 7.12.07
Latest News on Avandia: German Study Adds More Reasons to Avoid itLatest Study in the News: Avandia May Worsen Complications of Diabetes
News & Warnings
Avandia Breaking News: Glaxo Warned in 2001 about Misleading MarketingBloomberg News: FDA Warned Glaxo about Avandia Marketing in 2001


