Pharma giant GlaxoSmithKline (GSK) has confirmed the updated warning label and medication guide for the diabetes drug Avandia (rosiglitazone) in the US. The company have stated that all the new labelling includes details on new required restrictions on Avandia use and worries regarding potential heart problems issued by the Food and Drug Administration (FDA).
The changes, which will affect all rosiglitazone-based drugs, such as Avandia, Avandaryl and Avandamet, and will point out that Avandia is only available to those people that are already taking the drug or who have not been able to control their diabetes with other medications.
GSK have also provided an updated black box warning that details those clinical trials that showed a statistically significant heightened risk of myocardial infarction and says that trials have indicated that the competing drug, Actos, developed by Takeda Pharmaceuticals, does not appear to have the same risks. GSK have already reportedly made a number of settlements over Avandia, which has been taken by millions of people suffering from type 2 diabetes to treat their levels of blood sugar since its launch in 1998.
The new black box warning was required as the FDA said the one issued in September last year was offered an insufficient warning about the potential dangers of the drug and restricted use. Avandia has already been withdrawn from sale in Europe.

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