Critic Says Avandia Should Be Banned

Toronto, ON, CanadaA doctor who was critical of the use of the drug Avandia is criticizing Health Canada for allowing the diabetes drug to stay on the market despite Avandia side effects. Much like the US Food and Drug Administration (FDA) response to Avandia risks, Health Canada has advised serious restrictions about whom could be prescribed the medication, but did not pull it from the market entirely.

According to the journal CMAJ (the Canadian Medical Association Journal; 12/15/10), Dr. David Juurlink says that Health Canada's decision makes doctors responsible for the safe use of Avandia and complicates both doctor's and patient's lives.

On November 19, 2010, a "Dear Doctor" letter from GlaxoSmithKline Inc., advised physicians in Canada that Avandia should only be used on patients who did not respond to any other diabetes medication. Furthermore, doctors are now required to have patients sign a consent form, indicating they are aware of the serious risks associated with Avandia use. Those serious side effects include an increased risk of heart attack and stroke.

Earlier this year, the FDA voted to severely restrict use of Avandia, but did not pull the drug from the market entirely. The FDA also stopped a clinical trial, the Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE), which involved some patients taking Avandia to compare its safety with that of rival drug, Actos. The move was made after a panel of health experts voted that Avandia increases the risk of heart attack when compared with other drugs.

The FDA said it allowed Avandia to remain on the market because data about the risk of cardiovascular side effects was conflicting. The agency also noted that there are individuals who could still benefit from Avandia use.

Despite the FDA's move, the European Medicine Agency withdrew Avandia from the market entirely.

Juurlink called Health Canada's decision a "weak-kneed response," and noted that many physicians are unaware of Health Canada's recommendations about Avandia.

GlaxoSmithKline faces lawsuits in both Canada and the US regarding Avandia. According to the CMAJ report, the drug maker has settled some lawsuits in the US but has not done so in Canada. In July, GlaxoSmithKline reportedly settled approximately 10,000 lawsuits for around $460 million, leaving approximately 3,000 lawsuits pending.