Abbott Laboratories agreed to pull its 13-year-old diet pill Meridia off the U.S. market because of heart attack and stroke risks.

The company announced the removal Friday at the request of the Food and Drug Administration after Meridia was tied to 16 percent more major cardiovascular side effects in a study of 10,000 high-risk patients who were followed for as long as six years. An estimated 100,000 Americans now take Meridia, and Abbott no longer promotes the drug in the United States.

The FDA’s action comes nine months after Meridia was forced off the market in Europe because of safety concerns. Coupled with the agency’s clash with European regulators in deciding against a recall of GlaxoSmithKline Plc’s diabetes pill Avandia in September, critics say the FDA is increasingly negligent in its public-health mission.

“The FDA’s decision to ask Abbott to withdraw the drug is commendable, but dangerously too late for all of the victims of its unacceptable risks,” said Sidney Wolfe, head of health research at the consumer group Public Citizen, in an e-mailed statement Friday.

Abbott said it would also halt sales of Meridia in Canada and in Australia. Global sales of the drug in the first nine months of this year were $80 million, including $20 million in the United States. Abbott said it will report an expense tied to the withdrawals in the third quarter that won’t alter its quarterly or full-year forecasts.

Meridia was approved in the United States in 1997 even as evidence showed it can raise blood pressure and heart rates. The FDA said Friday that those risks were thought to be acceptable because they could be easily monitored and because weight loss seen in studies of the drug was expected to be good for the heart.

The long-term safety study found the drug led to “only modest weight loss” of about 2.5 percent more than a placebo, said John Jenkins, director of the FDA’s Office of New Drugs, in a conference call with reporters Friday.

The agency is reviewing whether longer studies of cardiovascular risks are needed before approving drugs intended for chronic use, particularly when patients may already be at increased risk for heart complications, Jenkins said.

Safety concerns have prompted 22 drugs to be withdrawn from the market in the past 15 years, half because of heart risks, according to FDA data obtained by Bloomberg News.

By Catherine Larkin, Bloomberg News