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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

FDA Safety Announcement May Bring New Avandia Lawsuits

Posted in Misc. Drugs, Safety Alerts

I got an email from the FDA alerting me to new warnings about the usage of Avandia.  Apparently, the FDA has not decided to withdraw Avandia, but is severely restricting who may use it:

FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.

Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly.

Source: Avandia (rosiglitazone): REMS – Risk of Cardiovascular Events

This will hurt GlaxoSmithKline (GSK) in two ways.  First, the obvious pain will come in the form of reduced sales.  Avandia can no longer be used as a first-line treatment for patients with diabetes.    New prescriptions are going to drop like a rock.

Second, this announcement will probably spur a second wave of Avandia lawsuits.  That’s because an entirely new batch of people will see this news announcement and decide to contact an Avandia lawyer.  I know that GSK has already settled quite a few Avandia lawsuits, but their defense attorneys should probably gear up for another round.