Avandia Heart Risks News

Glaxo’s Avandia to Be Pulled in EU, Restricted in U.S.

- Bloomberg

09/23/2010 - GlaxoSmithKline Plc’s Avandia, once the world’s best-selling diabetes drug, will be withdrawn from the market in Europe and sales will be limited in the U.S. because of an increased risk of heart attacks, regulators said in decisions announced almost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.

Glaxo will stop promoting the drug in all countries in which it operates, the company said in an e-mailed statement today. Doctors should stop prescribing the treatment, the European Medicines Agency said in a statement. The London-based regulator said it found no measures that could be taken to reduce the risk.

In the U.S., the drug will carry new warnings 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. The decision to allow continued sales of the drug follows the recommendations of an FDA advisory panel in July.
“We struggled with it, and colleagues in other jurisdictions struggled as well,” Hans-Georg Eichler, the EMA’s senior medical officer, said on a conference call with reporters. “There’s no single perfect tool to study this risk.”

Heart Attack Risk
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 FDA in July called for stronger warnings on the label after re- examining a 2007 decision to keep the medicine on the market. Glaxo has said “extensive clinical data” have shown the drug to be safe.

Glaxo’s American depositary receipts fell 36 cents, or 0.9 percent, to $39.79 at 12:16 p.m. in New York Stock Exchange composite trading. “The company continues to believe that Avandia is an important treatment for patients with Type 2 diabetes and is now working with the FDA and EMA to implement the required actions,” according to Glaxo’s statement.

“Our primary concern continues to be patients with Type 2 diabetes and we are making every effort to ensure that physicians in Europe and the U.S. have all the information they need to help them understand how these regulatory decisions affect them and their patients,” Ellen Strahlman, Glaxo’s chief medical officer, said in an e-mailed statement.

Falling Sales
Avandia and Avandamet, which both contain the active ingredient rosiglitazone, last year garnered revenue of 771 million pounds ($1.2 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 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.

Increased Danger
“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 EMA said today.

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.”

“We are not withdrawing the drug at this time because there is considerable uncertainty about this signal and whether it is valid,” said Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research, on a conference call today with reporters. The next step is for independent doctors to review Glaxo’s Record study.

The new risk-management program will take “several months” to implement, the FDA said. Doctors will have to enroll patients and document their need for the medicine. New patients must show that they aren’t able to take Actos.

European regulators may reconsider their decision if new data emerges on Avandia, said FDA Commissioner Margaret Hamburg. The agencies came to different conclusions on how best to protect patients because the U.S. is comfortable relying on restricted access programs to manage risks, Hamburg said.

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