A September 23, 2010 article in the New England Journal of Medicine announced that, finally, the FDA has stepped forward and decided on regulatory action for Avandia, a diabetes drug that last year claimed 1,354 lives as a result of cardiac-associated problems.
The FDA is restricting access to Avandia by requiring GSK to submit a Risk Evaluation and Mitigation Strategy, or REMS.
Under the ruling, the drug will be available to patients not already taking it only if they are unable to achieve glycemic control using other medications and, in consultation with their health care professional, decide not to take a different drug for medical reasons.'
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