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Avandia trial "risky", group claims

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PharmacyEurope

May 17, 2010

An ongoing trial of GlaxoSmithKline's Avandia puts patients' lives at risk and should be stopped immediately, a US pressure group has claimed.

Public Citizen said the diabetes drug, which has been investigated by the Food and Drug Administration (FDA) in the past over allegations it increased the risk of heart attack and chest pain, had an "unfavourable" risk profile and it urged the regulator to bring an end to the test.

Major concerns about Avandia were first raised in 2007. An FDA investigation of the treatment at the time noted its safety risks but decided to keep in on the market.

A later probe into the drug called for a "black box" warning on the product's packaging after a review of 42 studies linked it to an increased likelihood of heart problems.

FDA officials are believed to be taking a closer look at Avandia ahead of their scheduled summer meeting.

A spokesman for Glaxo said the company stood by the treatment.



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