The Rosiglitazone Story — Lessons from an FDA Advisory Committee Meeting

  • Rosen C
  • 57

    Readers

    Mendeley users who have this article in their library.
  • 0

    Citations

    Citations of this article.

Abstract

On July 30, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the FDA concluded that the use of rosiglitazone for the treatment of type 2 diabetes was associated with an increased risk of myocardial ischemic events. Dr. Clifford Rosen reports. On July 30, 2007, the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration (FDA) convened to discuss the myocardial ischemic risk associated with rosiglitazone treatment in patients with type 2 diabetes mellitus. The joint committee, which I chaired, consisted of 24 experts in cardiovascular disease, epidemiology, biostatistics, and endocrinology. After lengthy discussions, we concluded that the use of rosiglitazone for the treatment of type 2 diabetes was associated with a greater risk of myocardial ischemic events than placebo, metformin, or sulfonylureas. That conclusion was based primarily on . . .

Get free article suggestions today

Mendeley saves you time finding and organizing research

Sign up here
Already have an account ?Sign in

Find this document

Authors

  • Clifford J. Rosen

Cite this document

Choose a citation style from the tabs below

Save time finding and organizing research with Mendeley

Sign up for free