Major US consumer group asks FDA to ban drug for diabetes

doi:10.1136/bmj.a2401

Published 5 November 2008, doi:10.1136/bmj.a2401
Cite this as: BMJ 2008;337:a2401

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Major US consumer group asks FDA to ban drug for diabetes

Janice Hopkins Tanne

¹ New York

The first 150 words of the full text of this article appear below.

Public Citizen, a US national consumer advocacy group, has petitionedthe US Food and Drug Administration to ban the drug rosiglitazone(sold as Avandia), which is prescribed for type 2 diabetes.

The group said that liver failure, often fatal, was a newlydocumented risk with the drug, which is made by GlaxoSmithKline.Previously the drug had been linked to an increased risk ofheart attacks, heart failure, bone fractures, and eye problems,Public Citizen said.

The drug now carries a "black box" warning from the FDA, sayingthat it may cause heart attacks and congestive heart failure(BMJ 2007;334:1237, doi:10.1136/bmj.39244.394456.DB).

GlaxoSmithKline issued a statement saying it believed thereto be no issue of liver safety with rosiglitazone. The companysaid that an external safety board reviewed liver problems thatmight be related to rosiglitazone. "As recently as July 2008,"the statement said, "this panel of experts continued . . . [Full text of this article]

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