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Avandia safety concerns hit GSK shares

Published on 31/05/07 at 11:07am

Shares in GSK have taken another hit after news that US prescribers have turned away from diabetes drug Avandia in response to safety fears.

A study suggesting the drug significantly raised the risk of a heart attack was published in the New England Journal of Medicine on 21 May, causing considerable concern for patients and regulators around the world.

The FDA and EMEA have both concluded that a withdrawal, or any other immediate action, is not required. But in the long-term, Avandia may have to carry a new 'black box' safety warning.

Now, sales data from the first few days after the safety warning show that US prescribers are steering clear of the drug.

A report by ImpactRx shows Avandia's share of new prescriptions fell from 10% to almost zero in the immediate aftermath of the news - a trend that would be disastrous for GSK if it were to continue.

GSK has said fears about the drug's safety have been exaggerated, but it has been unable to calm the market, which has seen GSK's share price drop several times.

Analysts Deutsche Bank commented: "While two days of prescription data cannot be regarded as a rigorous test of clinician sentiment to the NEJM article, this reaction is far worse than we anticipated, and suggests that there could be as much as 22% downside risk to GSKs near-term earnings."

The analysis of data retrieved from 42 clinical studies showed a small increased risk of heart attack and cardiovascular death in around 15,500 patients treated with Avandia (rosiglitazone)

But deaths from all causes were not significantly increased, and contradictory clinical trial data exists which suggests the drug actually helps cardiovascular health in diabetes patients.

Patients already taking Avandia currently seem unlikely to be switched away from the drug, but the FDA says patients can consult with their doctors and make a decision based on their individual circumstances.

The ImpactRx data also showed that Takeda's rival glitazone treatment, Actos, had benefited from Avandia's setback, although there is no evidence to suggest the drugs significantly differ in their cardiovascular profile.


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