Rosiglitazone, an oral drug that reduces the amount of sugar (glucose) in the blood and is used for treating patients with type 2 diabetes is being recalled by the Government Analyst/Food and Drug Department of the Ministry of Health.
The department in a press release yesterday stated that it is recalling rosiglitazone, marketed as Avandia (Rosiglitazone), Avandamet (Rosiglitazone, Metformin), and Avandaryl (Rosiglitazone, Glimepiride) which is manufactured by GlaxoSmithKline.
Rosiglitazone is used as a mono or combination therapy.
And the marketing authorization issued by the European Medicines Agency (EMA) has been suspended and all products will be withdrawn from the market, since the heart attack risks associated with the former blockbuster drug are too great a safety concern to continue its use, the release said.
In addition the Food & Drug Administration (FDA) in the US has restricted the use of rosiglitazone because of suspected elevated risk of cardiovascular events such as heart attack and stroke.
The FDA is currently conducting a Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) study designed to evaluate the cardiovascular safety.
In the meantime, labeling revisions are currently under review by Health Canada to add serious warnings and a precaution box to the product monograph of medicines containing rosiglitazone.
Patients who were prescribed rosiglitazone are advised to consult with their health care provider concerning the risks of this medication, the release advised.
The department can be contacted at the Institute of Applied Science and Technology (IAST) Building, University of Guyana, Turkeyen Campus, or via telephone 592-222-8857 to 8861.
