Use of Rosiglitazone an anti diabetic drug, inspite of its sustained glycemic control has been restricted by the FDA due to increased cardiovascular incidents reported. Read on to know more.

Team@CMHF

Rosiglitazone (Avandia) will no longer be available in retail pharmacies after Nov. 18, according to a new risk evaluation and mitigation strategy (REMS) document released Wednesday by the FDA.
Instead, physicians wishing to prescribe the type 2 diabetes drug will have to enroll their patients in a special registry; the drug will be dispensed through mail order to patients on the registry from specially certified pharmacies, according to the agency.

The FDA noted that it was making the change “based on data that suggested an elevated risk of heart attacks in patients treated with rosiglitazone.” The decision to restrict access to the drug was made in September 2010, but FDA has been working with GlaxoSmithKline, which manufactures rosiglitazone, to finalize new labeling for the drug and roll out the REMS.

The REMS limits the use of rosiglitazone — also marketed as a combination drug containing other anti-diabetic medications under the names Avandamet and Avandaryl — to patients who are already being successfully treated with it, as well as “patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare provider, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).”

Healthcare providers who want to prescribe rosiglitazone to their outpatients, or patients in long-term care facilities, will be required to review the prescriber overview and full prescribing information for the drug, including a medication guide, as well as sign an enrollment form. If a patient who has been taking a rosiglitazone medicine is hospitalized, the patient must be enrolled in the registry — known as Avandia-Rosiglitazone Medicines Access Program — to continue receiving the medicine.

Ref: http://www.medpagetoday.com/PrimaryCare/Diabetes/26566?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&userid=333280