New Avandia restrictions announced in Canada and a decision is expected from the FDA soon
The makers of Avandia, GlaxoSmithKline, PLC, have placed new restrictions in Canada on the use of their popular type II diabetes drug. The new labeling comes after a Health Canada review of clinical data found an increased risk of heart related problems. Earlier this year, a report published in the New England Journal of Medicine suggested that users of the drug could face a 43% increased risk for heart attacks and many have questioned whether the drug should be removed from the market.
>>INFORMATION: Avandia Heart Problems
Avandia is the brand name for the generic drug rosiglitazone. It is also included in Avandamet and Avandaryl. According to the Canadian Press, the new prescribing information indicates:
- Avandia should only be taken alone or with a sulfonylurea drug, such as glyburide, if metformin is contraindicated or can not be tolerated.
- Avandia should only be used in combination with metformin when metofrmin alone does not provide good blood-surgar control.
- Avandia should not be used in patients with any stage of heart failure
- Avandia should not be taken if insulin is also being used
- Avandia should not be taken in combination with metoformin and a sulfonylurea drug, as a “triple therapy”
Avandia is a popular drug which generated $3.3 billion in sales worldwide last year. However, the medication can worsen some heart problems and lead to heart failure, swelling and weight gain as a result of side effects which can cause the body to retain fluid.
The FDA is continuing to review the safety of Avandia in the United States and they are expected to announce their final decision within the next few days. There has been a lot of internal debate within the agency about whether an Avandia recall is necessary to protect consumers. However, recent reports have indicated that an internal FDA panel voted narrowly last month to add an Avandia black box warning about the risk of heart attacks instead of removing the drug from the market.
AVANDIA LAWYERS
Thousands of users of the diabetes drug have suffered heart attacks or heart related death which could have been prevented if GlaxoSmithKline, PLC had acted responsibly and provided proper warnings about the risks associated with their medication. Researchers have estimated that one additional person out of every 30 individuals taking Avandia will suffer heart failure and one out of every 220 will suffer a heart attack.
>>INFORMATION: Avandia Lawsuits
The Avandia lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for individuals who have suffered a heart attack, stroke, heart failure or death after taking the medication. If you, a friend or family member believe an injury may have been caused by Avandia, request a free claim evaluation.
