FDA is replacing prescribing and distribution restrictions for rosiglitazone-containing medicines, including GlaxoSmithKline PLC’s Avandia and generics, with a requirement for prescriber training on the current state of knowledge about the diabetes drug’s cardiovascular risks.
The agency’s action amounts to a significant easing of the current REMS restrictions on the thiazolidinedione but not a complete elimination of the program’s elements to assure safe use (ETASU)
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