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FDA panel split on Avandia decision (20 to 12 to keep on market)

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Robbien Donating Member (1000+ posts) Send PM | Profile | Ignore Wed Jul-14-10 04:14 PM
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FDA panel split on Avandia decision (20 to 12 to keep on market)
Source: CNN

WASHINGTON (CNN) -- A Food and Drug Administration committee delivered a split verdict on the diabetes drug Avandia on Wednesday, with 12 of the 33 members voting to pull it from the market but smaller blocs voting to leave it available with beefed-up warnings.

The vote came on the second day of hearings into the safety of the drug, which studies since 2007 have linked to an increased risk of heart failure. Only three members of the committee voted to leave the drug on the market with its current labeling, while seven wanted to add stiffer language to the label and 10 wanted both stiffer language and additional restrictions on its use.

Read more: http://money.cnn.com/2010/07/14/news/companies/FDA_avandia.cnnw/index.htm?section=money_topstories&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+rss%2Fmoney_topstories+%28Top+Stories%29




FDA research shows high heart health risk. GlaxoSmithKline's study shows high heart health risk.

But three members said leave drug on market anyway. Seventeen said put skull and cross bones on label but otherwise leave it on market. Twelve said toss that stuff in the garbage.

Would a responsible company still sell the stuff?
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