GlaxoSmithKline Inc., the manufacturer of a drug for treating Type 2 diabetes has placed new restrictions on use of the medication based on a Health Canada review of clinical data pointing to an increased risk of heart-related problems in some patients.
In consultation with Health Canada, Glaxo is updating prescribing information on products made from or containing the drug rosiglitazone: Avandia, Avandamet and AvandarylTM.
Once touted as the gold standard for preventing Type 2 diabetes in high-risk patients, rosiglitazone lost its glitter after a study published in the New England Journal of Medicine in May showed Avandia significantly raised the risk of heart attack and possible death.
The NEJM analysis of 42 studies revealed a 43 percent higher risk of heart attack for those taking rosiglitazone compared to people taking other diabetes drugs or no diabetes medication at all.
Glaxo said patients taking rosiglitazone and especially those with underlying heart disease or with a high risk of heart attack or heart failure should talk to their doctor about the benefits and risks of continuing the drug.Important restrictions for patients are:
- Rosiglitazone should not be used in patients with any stage of heart failure
- Rosiglitazone should not be taken if insulin is also being used.
- Rosiglitazone should not be used as part of a "triple therapy" in combination with metformin and a sulfonylurea drug.
Rosiglitazone can cause the body to retain fluid, which can worsen some heart problems and lead to heart failure, swelling and weight gain.
Several lawsuits have been launched in Canada and the United States over the medication's adverse effects, and drug safety regulators in both countries have been investigating its safety.CBC
No comments:
Post a Comment