US regulators relax restrictions on rosiglitazone

BMJ 2013; 347 doi: (Published 28 November 2013) Cite this as: BMJ 2013;347:f7144
  1. Michael McCarthy
  1. 1Seattle

The US Food and Drug Administration announced on 25 November that it is to lift most of its restrictions on GlaxoSmithKline’s antidiabetes drug rosiglitazone and would no longer limit its use to patients whose diabetes could not be controlled by other drugs.

Rosiglitazone (marketed as Avandia) was approved in the United States in 1999, but its safety came into question after a meta-analysis published in 2007 by the New England Journal of Medicine found a 43% increase in the incidence of myocardial infarction and a 64% increase in death from cardiovascular causes.1

However, another …

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