Avandia to be pulled from European market, restricted in U.S.

GlaxoSmithKline Plc's Avandia, once the world's best-selling diabetes drug, will be withdrawn from the market in Europe and sales will be limited in the U.S. because of an increased risk of heart attacks, regulators said in decisions announced almost simultaneously.

"Data from clinical trials, observational studies and meta-analyses of existing studies that have become available over the last three years have suggested a possibly increased risk of ischaemic heart disease associated with the use of rosiglitazone," the European Medicines Agency said in an e- mailed statement today.

In the U.S., the drug will carry new warnings about heart risks after a three-year battle that divided staff at the Food and Drug Administration. London-based Glaxo must add new cautions to Avandia's prescribing information, the agency said today. While the decision to allow continued sales of the drug follows the recommendations of an FDA advisory panel in July, analysts say it is likely to spark increased criticism from doctors, lawmakers and consumer groups.

Avandia's sales have fallen since a study published in the New England Journal of Medicine in 2007 showed a 43 percent increased risk of heart attacks from the drug. Advisers to the U.S. Food and Drug Administration in July called for stronger warnings on the label after re-examining a 2007 decision to keep the drug on the market. Glaxo has said "extensive clinical data" have shown Avandia to be safe.

Glaxo's American depositary receipts fell 32 cents, or 0.8 percent, to $39.83 at 11:40 a.m. in New York Stock Exchange composite trading.

Avandia and Avandamet, which both contain the active ingredient rosiglitazone, last year garnered revenue of 771 million pounds ($1 billion), down from 1.6 billion pounds in 2006. Actos, from Takeda Pharmaceutical Co., is the world's best-selling diabetes medicine, generating 387 billion yen ($4.6 billion) in the year ended March 31, according to the Osaka, Japan-based company's annual report.

Glaxo conducted a study of Avandia, dubbed Record, at the request of European regulators. The 4,447-person, five-year trial study found that Avandia more than doubled the risk of heart failure without increasing the rate of hospitalization or death from cardiovascular causes, compared with older diabetes medicines. The data, presented in June 2009, are limited because more people in the group receiving Avandia were taking cholesterol medications and patients and doctors knew which diabetes drug was prescribed.

A study published last month found that Actos, which is the same type of treatment as Avandia, causes as many heart problems as the Glaxo medicine. Takeda says the drug is safe.

FDA reviewers were divided about the Record study, according to documents released on July 9. Thomas A. Marciniak, a medical team leader at the agency, said Record "was inadequately designed and conducted," while Ellis Unger, deputy director of the FDA's Office of Drug Evaluation, called the results of the study "reassuring."