US regulators relax restrictions on rosiglitazone

28-11-2013 BMJ NewsComments (0)


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.

However, another …

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