U.S. government health regulators will allow GlaxoSmithKline to continue selling a controversial diabetes pill but will restrict access to the once-blockbuster drug because of heart attack risks.
The Food and Drug Administration says new patients will get a prescription for Avandia only if they cannot control their diabetes with other medications.
The FDA's decision marks the second time in three years that the agency has decided to leave Avandia on the market, despite mounting pressure to recall the drug from outside medical experts, politicians and some of its own scientists. In July, a panel of FDA advisers voted to keep the pill available for diabetics. While the agency isn't required to follow the panel's advice, it usually does.
The FDA first approved the drug in 1999 and it became the top-selling diabetes pill in the world. But use has plummeted since a 2007 analysis linked the drug to heart attack risks.
Also Thursday, the European Medicines Agency says diabetes drug Avandia should be pulled from market. The agency is responsible for scientifically evaluating medicines that will be used in Europe.
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