Federal 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 can’t 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.
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.
European Medicines Agency says diabetes drug Avandia should be pulled from market.
In a news briefing on Thursday, the agency said it would suspend its marketing authorizations for the controversial drug which is linked to heart attacks.
It said the drug would be removed from the market within the next few months.
Earlier this month, Britain’s drug regulator said an independent panel of experts concluded Avandia raised the risk of heart attacks and recommended it be pulled from the market.
Avandia was approved by the European Medicines Agency in 2000 to help lower blood sugar levels in diabetes patients, but its use was restricted only to certain patients.