GSK scales back US health warnings for Avandia

pharmafile | November 15, 2007 | News story | Sales and Marketing |   

GlaxoSmithKline will update US labelling for its diabetes treatment Avandia to state there is no conclusive evidence linking it to serious cardiovascular side effects.

The company's move was prompted by new FDA findings, which cannot confirm nor rule out that Avandia increases the risk of heart attack or stroke.

The new data is good news for GSK, which has seen sales of Avandia plummet after safety concerns over the potential side effect were raised in May this year.

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The drug was the most widely prescribed oral-diabetic medicine, but US sales in the third quarter this year were down 48% compared to the same time in 2006.

Dr Ronald Krall, GSK's chief medical officer said: "Avandia remains a safe and effective medicine for most patients with type 2 diabetes when used appropriately.

"Given the severity of this disease and the importance of Avandia in helping patients manage their diabetes, we will continue to work with the FDA to conduct more studies about the safety and benefits of our medicine." 

GSK again highlighted that diabetes sufferers with existing heart problems or poor blood flow should avoid the drug altogether and said it would add a new warning that Avandia is not recommended – but not banned  for patients taking insulin or nitrates.

The labelling for the other products in GSK's Avandia franchise, including Avandamet and Avandaryl, will also be updated in the future.

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