RESTRICT the Avandia Use

[FDA MedWatch] Elevated Risk of Heart Attack and Stroke

(편집자 주 - 미국FDA는 심장질환과 뇌졸중 부작용 우려가 제기된 영국 제약기업 글락소스미스클라인의 당뇨병 치료제 '아반디아 -  Avandia'의 사용을 규제하는 조치를 발표한 내용입니다.). 

AUDIENCE: Endocrinology, Cardiology

ISSUE: FDA notified healthcare professionals and patients that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications.

These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

BACKGROUND: Avandia is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus.

Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

RECOMMENDATION: FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS.

Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.

Doctors will have to attest to and document their patients' eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks.

The agency anticipates that the REMS will limit use of Avandia significantly.