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Published on 15 July 2010

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Avandia approved with restrictions

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US advisers have recommended a controversial diabetes treatment should be allowed to remain on sale.

However the Food and Drug Administration panel said Avandia, which had been one of GlaxoSmithKline’s best-selling medicines, will be subject to tough new restrictions after it was linked to an elevated risk of heart attacks.

In a majority decision, the panel earlier ruled Avandia is more likely to cause heart attacks than its closest competitor Actos however, the risk was not judged to be sufficiently severe to justify withdrawing the treatment from market.

The Food and Drug Administration is not obliged to follow the panel’s recommendations, although the regulator rarely goes against advice it has received. FDA officials said they would review the recommendations and make a decision as soon as possible.

Sales of the drug, which have been in steep decline since studies first linked it to heart attacks, are likely to fall further.

However the ruling could still prove significant for Glaxo, which is facing thousands of lawsuits from US patients who claim Avandia was responsible for their heart attacks or strokes.

Copyright Press Association 2010

Food and Drug Administration



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