Avandia Recalled in South Africa Over Heart Risks

South Africa has joined the growing list of countries who have recalled the diabetes drug Avandia due to the risk of heart problems and death, although the medication remains available in the United States with severe restrictions on who can receive the drug. 

Earlier this month South Africa’s Medicines Control Council (MCC) withdrew permission for GlaxoSmithKline to market Avandia in that country. Glaxo officials said they have been notified of the decision and decided not to appeal it.

The MCC is not allowed to discuss its decision until it receives official recognition of notification from the manufacturer, officials have said. However, Avandia was recalled in South Africa after similar decisions were reached in other countries due to concerns about an increased risk of heart attacks and congestive heart failure from Avandia side effects.

Avandia (rosiglitazone) was first introduced in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics throughout the world, but sales began to plummet in mid-2007, after potential Avandia heart risks were highlighted in a study published by the New England Journal of Medicine.

A “black box” warning was added to Avandia in the United States in November 2007, but many critics continued to argue that the warning was not strong enough and called for an Avandia recall to be issued in the United States.

Despite heated internal debate, the FDA decided in September 2010 not to recall Avandia in the United States, allowing the medication to remain on the market with severe restrictions on who can use the product. The agency determined that only patients who have failed to control their diabetes through every other available medication should be given access to the medication, and ordered the drug’s maker, GlaxoSmithKline, to develop a risk evaluation and mitigation strategy (REMS) to make sure the drug is adequately restricted.

GlaxoSmithKline has faced thousands of Avandia lawsuits in the U.S. filed by people who allege that the drug maker failed to adequately warn about the risk of heart problems from Avandia. A number of Avandia settlements have reportedly been reached by GlaxoSmithKline in an effort to resolve the litigation, but thousands of cases are still pending in courts throughout the country.