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Published on 19 April 2010

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FDA may drop GSK drug safety study

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The FDA may stop a safety study on GlaxoSmithKline’s diabetes drugAvandia – which has been linked to an increased risk of heart attacks -the Wall Street Journal (WSJ) reports.

Any such move could seriously dent the company’s reputation and risk the drug’s presence in the US market.

The diabetes treatment has been in the spotlight since 2008 when is it was linked to heart problems.

It was also the subject of a report by two senators, Max Baucus and Charles Grassley, in February.

The WSJ suggested the US regulator was now in favour of pulling thedrug, as revealed by memos included in the aforementioned study.

Avandia was suspended for six months by Saudi Arabia’s Food and DrugAuthority in March, with the body arguing the potential risksoutweighed the benefits.

Glaxo said the scientific evidence for the assertion was far fromdefinitive, adding it has always been open in providing informationabout the drug.

Copyright Press Association 2010
GlaxoSmithKline



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