Avandia: GlaxoSmithKline agrees to settle before FDA vote
Posted by: Stephen Leshner
July 14, 2010
Topic: PRODUCT LIABILITY
The move comes as the Food and Drug Administration votes today whether or not to withdraw Avandia from the market over its heart attack risks.
GlaxoSmithKline will settle about ten-thousand lawsuits for an average payout of $46,000 apiece.
Avandia's U.S. sales comprised only a tiny one-and-a-half percent of the British drugmaker's 2009 sales.
Its withdrawal from the market could spur more lawsuits, however.
The FDA could choose to keep Avandia on the market but beef up its black-box warning about the risk of heart attacks.
The other option would be to further restrict Avandia's use.
Glaxo moved quickly after two U.S. Senators ratcheted up the pressure yesterday by releasing documents underscoring safety concerns with the drugs.
The documents showed Glaxo had tried to brush off scientific concerns about the increased risk of heart attack in users.
The FDA is also under pressure of its own, coming from consumer groups eager to test the Obama administration's promises of a more activist watchdog role for the agency.
If you or someone close to you has been injured as a result of taking Avandia, please call Steve Leshner.
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