Monday, September 27, 2010

Canada weighs tighter rules on Avandia diabetes drug

From the Globe and Mail:
Popular diabetes drug Avandia is being pulled off the market in Europe and will face tighter restrictions in the U.S. because of fears patients who take it face an increased risk of heart attacks, stroke and other cardiovascular problems.

The decision is a blow to GlaxoSmithKline Inc., the company that sells Avandia, the brand name of the diabetes drug rosiglitazone.

It also raises questions about further regulatory restrictions in Canada. Health Canada said in 2007 that, because of the potential for cardiovascular problems, Avandia shouldn’t be taken on its own unless patients can’t tolerate other diabetes drugs. Similar restrictions were announced Thursday by the U.S. Food and Drug Administration.

But the European Medicines Agency, which evaluates drugs in the European Union, recommended suspending Avandia’s market authorizations and said it would no longer be available there in the next few months.

In July, Health Canada said it was continuing to review the safety of Avandia and that it was closely monitoring developments in the U.S. The department issued a public advisory in July saying it would take “the appropriate regulatory action necessary” pending the outcome of safety investigations in other countries. ...more

No comments: