New Zealand drug regulators have decided to withdraw Avandia from their market due to the risk of heart problems, joining a growing list of countries that have gone one step farther than the United States, which decided last year to allow the controversial diabetes drug to remain on the market with severe restrictions on use.
Medsafe, New Zealand’s medication regulatory agency, announced that an Avandia recall has been scheduled for April 29. It has been determined that the risk of Avandia side effects outweigh the potential benefits provided in treating diabetes.
Doctors in New Zealand have been asked not to start new prescriptions for Avandia and patients taking the drug across the island nation have been urged to see their health care professional about alternatives as soon as possible. However, the agency warns that patients should not stop taking the drug until they have spoken with their doctor. Medsafe officials estimate that Avandia is currently used by less than 100 patients in New Zealand.
In the United States, Avandia (rosiglitazone) was first approved in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics in the U.S., but sales began to plummet in mid-2007, following the concerns about potential Avandia heart risks.
A “black box” warning was added to Avandia in the United States in November 2007, but many critics have called for an Avandia recall to be issued in the United States.
In September 2010, the FDA decided not to recall Avandia, allowing the medication to remain on the market with even stronger warnings and 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 continues to face thousands of Avandia lawsuits in the United States filed by people who allege that the drug maker has placed their desire for profits before patient safety by failing 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.