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Controversial diabetes drug to stay on US market

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US health officials have voted to keep the diabetes pill Avandia on the market despite its controversial side effects.

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The vote on GlaxoSmithKline’s drug followed an earlier ruling by the same panel that Avandia appears to increase the risk of heart attack.

Special restrictions on sales will be brought in though, at the request of 10 of the Food and Drug Administration panelists following the 20-12 vote to keep the pill on the market.

The vote marks a tough win for British drug maker Glaxo, which is facing thousands of lawsuits from patients who say Avandia caused their heart attacks or strokes. While the company may fare better in court due to the panel ruling, sales of Avandia are likely to shrink to minuscule levels.

The FDA is not required to follow the advice of its panelists, though it usually does. FDA officials said they would review the recommendations and make a decision on Avandia as soon as possible.

Panelists voted 21-4 that Avandia is more likely to cause heart attack than its closest competitor Actos. Eight panelists said there was not enough information to make a decision.

Ultimately though, panelists said the risks were not severe enough to justify removing a drug used by hundreds of thousands of patients.


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