Use of diabetes drug Avandia is restricted by FDA

The (Raleigh) News & ObserverSeptember 24, 2010 

European medical authorities have suspended Glaxo SmithKline's onetime blockbuster diabetes drug Avandia, while U.S. regulators said they will require stricter safety warnings for the controversial medicine.

The parallel rulings Thursday mark the latest chapter in the decline of what was the world's best-selling diabetes medication after the drug was dogged by health concerns.

In this country, some patients will have to stop taking Avandia. The Food and Drug Administration is ordering restrictions on Avandia's availability to new patients, a move that's expected to reduce Avandia prescriptions significantly.

The FDA adopted the July recommendation of a federal advisory panel, whose 33members were deeply divided about the drug's safety, but voted that it should remain on the market.

The European Medicines Agency said Avandia will be phased out in Europe over the next several months and patients will need to find alternative treatments.

Health authorities inEurope and the United States cited concerns about the increased risk of heart attack and stroke from using Avandia.

The European and American regulatory organizations exchanged data and shared their conclusions with each other before making them public. The rulings were released almost simultaneously.

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