Avandia Canada: Reports of Heart Attacks

A new study from the New England Journal of Medicine published May 21, 2007 links the widely prescribed diabetes drug Avandia to an alleged increased risk of heart attack and even death. The Journal reported that dozens of studies together resulted in alleged evidence of a 43 percent higher risk of heart attack.

Since Avandia was approved by the FDA in 1999, more than six million people worldwide, including many patients in Canada, have taken the drug sold by London-based GlaxoSmithKline PLC.

The drug is used to treat Type 2 diabetes, the most common form of diabetes, which is linked to obesity. This disease results when the body does not make enough insulin or cannot properly use what it manages to produce -- Avandia helps sensitize the body to insulin.

Avandia Facts

• More than one million prescriptions for Avandia were filled in Canada in 2006;



• According to IMS Health Canada, Avandia ranked third in the oral diabetes class of drugs;



• The retail value of the prescriptions was $156 million in 2006;



• In 2005, 7.7 per cent of the population in Colchester, East Hants and Cumberland counties reported a diagnosis of diabetes, according to the CEHHA.



• That compares to a 6.6 per cent rate across Nova Scotia and a 4.9 per cent rate in Canada.



• For local seniors the diabetes rate was 20.9% in 2005.

The adverse drug reaction database has received approximately 28 Canadian reports of heart attacks in patients using Avandia since 2000, although Health Canada said "the causal nature of the association of these adverse events with Avandia has not been determined."

On May 27, 2007 the American Diabetes Association and two influential heart groups jointly released a statement advising diabetics to talk to their doctors before stopping any medication. The U.S. Food and Drug Administration has not yet asked for a recall (pending ongoing studies) but it has issued a safety alert about the potential risks.

This isn't the first time Avandia has been associated with adverse effects. On December 20, 2005 Health Canada reported an association between Avandia and Avandamet and vision problems in diabetics. GlaxoSmithKline, the maker of both drugs, sent a letter to Canadian health-care professionals informing them of this "new safety information" and advised patients not to discontinue Avandia without consulting a doctor.

Currently, Health Canada spokesperson Jirna Vlk says the department is aware of the New England Journal of Medicine study on Avandia and is doing its own analysis of the findings. Health Canada adds that there are no immediate plans to change the labeling for the medication.

Meanwhile, two-thirds of diabetics already die from heart attacksâ€"will Avandia increase the odds?

Avandia was approved by the FDA eight years ago because it led to short-term improvements in certain blood-sugar measurements. But some experts now question the value of this sign of diabetes control. At the time of Avandia's approval, the FDA did not require evidence of clinical benefit such as fewer blood-sugar crises, hospitalizations, etc.

"Had practicing physicians required this higher standard, they would have been at a loss" to find it based on the studies that led to approval, wrote Drs. Bruce Psaty of the University of Washington and Curt Furberg of Wake Forest University in the New England Journal of Medicine's editorial.

Next up for Avandia
U.S. Congressional Representative Henry Waxman, chairman of the House Committee on Oversight and Government Reform, announced a hearing for June 6, 2007 and has asked the FDA commissioner, Glaxo representatives and Nissen to attend. Other panels also are holding hearings.

What You Can Do
Experts advise patients not to stop taking the drug on their own but to discuss with their doctors all their risk factors for heart attacks, including the increased risks associated with diabetes. Keep a journal and ask your doctor a lot of questions; make sure you get enough exercise and eat a healthy diet. If you think you or a loved one has suffered any adverse side affects from taking Avandia, you may also want to contact an attorney.

Avandia Canada Articles

Warning to Avandia Patients in Canada
Avandia Canada patients have been warned to speak with their doctors after a study published in the New England Journal of Medicine allegedly found a link between the risk of heart-related problems and Avandia.

Link Between Avandia and Canadian Deaths Explored
Health Canada has confirmed that 19 people have died from heart related problems while they were taking Avandia.

Avandia in Canadian News

JUN-05-06: IMS Health Canada says that over one million prescriptions for Avandia were filled in Canada last year. The drug was ranked third in the oral diabetes drug class. [CBC: AVANDIA CANADA]

MAY-31-07: Health Canada says it has found a possible link between Avandia and death in six cases. There is still not enough information to determine whether the drug played a role in 12 other deaths. [TIMES: AVANDIA CANADA]

MAY-22-07: Canadians who take Avandia are being told to consult their doctors to discuss whether or not to continue with the medication following reports that the drug has been linked to an alleged increased risk of heart attacks. [CTV: AVANDIA CANADA]

MAY-21-05: Health Canada has said it is analyzing results of a recent study that alleged an increased risk of heart attacks in patients taking Avandia. [CBC: AVANDIA CANADA]

Avandia Canada Legal Help

If you or a loved one live in Canada and have suffered a heart attack or liver damage after taking Avandia, please click the link below to send your complaint to a lawyer to evaluate your claim at no cost or obligation.
Last updated on Jun-21-07