The European Medicines Agency says GlaxoSmithKline's Type 2 diabetes drug Avandia, which has been linked to heart attacks, will be taken off the market in Europe.
In a news briefing Thursday, the agency said it will suspend its marketing authorizations for the drug, also called rosiglitazone.
It said the drug will be removed from the market within a 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regulator said an independent panel of experts concluded Avandia raised the risk of heart attacks and recommended it be withdrawn from sale.
Avandia was approved by the European Medicines Agency in 2000 to help lower blood-sugar levels in diabetes patients, but its use was restricted to certain patients.
In the U.S., regulators will allow GSK to continue to sell the pill but will restrict access to the once-blockbuster drug because of heart attack risks.
The U.S. Food and Drug Administration said Thursday new patients will get a prescription for Avandia only if they can't control their diabetes with other medications.
In 2007, Health Canada issued usage restrictions on Avandia due to cardiovascular risks. At that time, the health agency said Avandia was no longer approved for use alone to treat Type 2 diabetes, nor approved for use with a sulfonylurea drug except when the drug metformin is "contra-indicated," or not tolerated.
In July, Health Canada said it was continuing to review new scientific evidence from FDA proceedings but had no new recommendations on the drug's use.
Health Canada's recommendations on using the drug alone and in combination with other diabetes drugs are more restrictive than in the U.S., the Canadian regulator said.
There was no immediate word Thursday from Health Canada on whether it planned any further restrictions on Avandia.
Avandia is used to treat Type 2 diabetes, the most common form of the disease, which is linked to obesity and afflicts 200 million people worldwide. This form of diabetes occurs when the body does not make enough insulin or cannot effectively use what it manages to produce.
Avandia helps sensitize the body to insulin.