Biotech Values

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Avandia restricted by FDA

The Food and Drug Administration announced Thursday that the diabetes drug Avandia will be restricted to patients with Type 2 diabetes whose condition cannot be controlled with other medications.

Also Thursday, the European Medicines Agency recommended that Avandia be taken off the market. The EMA is Europe’s counterpart to the U.S. Food and Drug Administration (FDA), and is responsible for the approval of all drugs and medical devices sold in Europe. To go into effect, the decision must be ratified by the European Commission.

The drug has been linked to raised risks of cardiovascular events, such as heart attack and stroke, in patients treated with it.

A recent article in the British Medical Journal argued the drug never should have reached the market in the United Kingdom, reports CNNMoney.

In July, an FDA panel gave a split decision on Avandia - most members agreed to leave it on the market, but recommended changes in prescribing it.

http://pagingdrgupta.blogs.cnn.com/2010/09/23/avandia-access-restricted-by-fda/?hpt=T1&iref=BN1