After multiple studies showed that the diabetes drug, Avandia, was causing higher than normal rates of heart events, attacks and failure, the FDA ordered the drug's maker, GlaxoSmithKline, to make major changes to the labeling of the drug.
The new label will state that Avandia (rosiglitazone) may only be started in patients who "are unable to achieve adequate glycemic control on other diabetes medications, and, in consultation with their healthcare provider, have decided not to take pioglitazone (Actos) for medical reasons."
In addition, the FDA has asked that the drug giant provide a statement, to be signed by patients, that ensures that they have reviewed the cardiovascular safety concerns about Avandia.
All of these steps were required by the FDA last September, when an advisory committee voted to keep the drug on the market but severely limit its use to only lower risk patients.
GlaxoSmithKline has stated that it is working to comply with all of the FDA's mandates. This includes reanalyzing data from a study that both the FDA and outside experts criticized for its questionable methods and outcomes.