US FDA Panel: Avandia Should Stay, But With Warning
The US Food and Drug Administration yesterday assembled a panel of independent experts in order to discuss the future of GlaxoSmithKline's much-maligned diabetes treatment Avandia. The initial verdict reached was that it should remain on the US market, even though previously published data suggested use of Avandia could cause the onset of cardiovascular problems. The majority of the panel did suggest, however, that explicit warnings are used in connection with the drug's sale - these displayed on its packaging.
The panel assembled was provided with various reports concerning Avandia in order to establish a consensus. The final vote in respect of whether Avandia could trigger heart complications was an overwhelming 20-3. Regarding whether it should, however, be withdrawn from the US market, only one voter supported the removal. Subsequently, shares in GlaxoSmithKline reversed their recent trend to gain 5.2 per cent.
Chris Viehbacher, the President of US Pharmaceutical at GlaxoSmithKline, confirmed that the drug giant's opinion remained that "no difference" in increasing exposure to cardiovascular risk was apparent when Avandia was place alongside alternative diabetes treatments.
Industry analysts have highlighted how, although the decision is the lesser of two evils for the pharmaceutical leviathan, it still represents a significant downturn in fortune. The recent connection made between Avandia and its heart attack risk generated a wave of bad press for GSK, but also, the US FDA itself came under fire in respect of it not market-monitoring the diabetes treatment. Subsequently, critics are urging for the regulator's finances to be increased at governmental level, in order for it to better track the progress of drugs once they are past the approval stage.
Diabetes is a condition affecting approximately 170 million people on a global basis. The majority of these have Type 2, where either insufficient levels of insulin are produced, or when what there is fails to be used properly.
The committee chair at the US FDA's meeting yesterday was Clifford Rosen. Summing up the ultimate opinion now offered on Avandia, he said: "The committee felt strongly that there was an increased risk", adding, "People are going to have to think twice before prescribing this medicine." Mr Rosen works at the Maine Center for Osteoporosis Research and Education.
As previously reported in Pharmaceutical International, the opinion provided by the expert collective at yesterday's meeting does not constitute an official verdict, as the US FDA itself will now consider the situation.
Source - Pharmaceutical International's External Contributor
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