WARNING ON AVANDIA ♦ INCREASED RISK OF HEART ATTACK ♦

NATIONAL - In a recent 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?

PATIENTS AT RISK | Avandia | FDA approval | GSK

NATIONAL - According to TIME (8/12, Park) reports that the FDA panel's recent decision to recommend keeping Avandia (rosiglitazone) on the market is "a move worth billions of dollars to GSK but that also may have put millions of patients at risk." The move is also an example "of the drug industry's outmaneuvering FDA regulators," which is "disturbingly common, say both scientists and policymakers who follow drug approval and safety monitoring." FDA critics and industry monitors "charge that the drug-approval process is too easy for pharmaceutical companies to game. It is in some ways an unsurprising development. The FDA serves a public insatiably hungry for new medicines. Yet the agency does not have responsibility for performing safety testing."