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.
Current users of Avandia will be able to continue using the medication if they appear to be benefiting from it and they acknowledge that they understand these risks. Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns.
But did the FDA go far enough – could it be too little, too late?
Unlike the US FDA, British regulators have ruled that GlaxoSmithKline’s diabetes drug Avandia could lead to heart attacks or strokes, and benefits no longer outweigh the risks.
And so last week, they told 90,000 British diabetes patients to stop taking it.
Evidence linking Avandia to an increased risk of a heart attack or stroke has been building since 2007, and GSK has agreed to pay $460 million in damages to settle about 10,000 lawsuits in America linking its use to patients suffering serious medical setbacks. But the US FDA has chosen only to monitor the drug, rather than ask for a recall.