Avandia is being pulled from the market in yet another country, this time in New Zealand. Sales of the controversial diabetes drug, which has been linked to side effects such as heart attacks and strokes, has been severely restricted in the U.S., but it remains on the market here.
The New Zealand Ministry of Health is withdrawing the diabetes drug Rosiglitazone from the New Zealand market as of April 29. The only medicine containing Rosiglitazone is currently marketed in New Zealand — Avandia. The decision for the Avandia recall was made after the ministry determined that the risk of Avandia side effects outweigh the potential benefits provided in treating diabetes.
“Patients who are taking Avandia are advised to make an appointment to see their doctor to discuss alternative treatments as soon as possible. Do not stop taking this medicine unless you have been advised by your doctor,â€ a health ministry statement said.
Avandia is not publicly funded in New Zealand and it is estimated less than a hundred patients are taking it.
Since November 2007, Avandiaâ€™s U.S. label has included a black box warning â€“ the U.S. Food & Drug Administration’s (FDA) strongest safety alert â€“ detailing its association with myocardial ischemia. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack. Since the addition of the black box, evidence linking Avandia to an increased risk of heart attacks has continued to accumulate.
Last year, the FDA restricted sales of Avandia, as well as two related drugs called Avandamet and Avandaryl, after concluding their association with an increased risk of heart attacks and strokes outweighed the drugsâ€™ benefits for most patients. At the same time, regulators in Europe announced that sales of Avandia and related drugs would be suspended.
Recently, drug maker GlaxoSmithKline announced it had reached an agreement to settle 5,000 U.S. Avandia lawsuits totaling $250 million, which averages out to about $46,000 each to each plaintiff. Glaxo previously settled around 10,000 Avandia heart attack and stroke claims, and it is estimated that it could face as many as 50,000 more claims.
Last month, Glaxo announced that it expects to record a legal charge for the fourth quarter of 2010 ($3.4 billion). According to a press release from the company, the charge primarily relates to additional provisioning in respect of the investigation by the U.S. Attorneyâ€™s Office for the District of Colorado into sales and promotional practices and for product liability lawsuits regarding Avandia. That was in addition to a $2.36 billion charge the company took last year elated to Avandia and Paxil litigation.