FDA Announces Access Restrictions to Avandia

Posted on behalf of Phillips Law Group on Sep 23, 2010 in Defective Drug

Avandia, manufactured by the pharmaceutical giant that is GlaxoSmithKline, has long been an extremely popular prescription choice by doctors for patients who suffer from type 2 diabetes. Avandia is generally used in conjunction with a specific diet and an exercise program, and for a time it worked quite well. Unfortunately, reports of Avandia side effects eventually began to arise, and this problem led to calls for help to Avandia lawsuit attorneys all over the United States. Now comes word that after much controversy, the FDA has announced steps to regulate the drug in response to these reports.

FDA Restrictions in Response to Reports of Avandia Side Effects

Specifically, the FDA has announced to the public that GlaxoSmithKline will be required to develop a specific restricted access program for Avandia. Basically new patients will only be allowed to use Avandia if they do not achieve success with their glucose control with other medications and if they are unable to use Actos, another type 2 diabetes drug. Patients who have been using Avandia will be able to continue to use it if they choose to do so. This step was taken in response to the growing concern regarding Avandia side effects that include the risk of cardiovascular events including heart attacks and strokes.

FDA Places Scrutiny on Avandia Studies

In addition to the announcement requiring restricted access, the FDA has also ordered an independent review of an Avandia study known as RECORD, which was done originally to study the risks of heart attacks and strokes while using Avandia. The FDA has questioned some of the reporting and intimated that bias could have clouded some of the conclusions. Finally, the FDA terminated an Avandia study known as TIDE, which was in progress and was comparing Avandia to Actos.

As can be seen, Avandia is coming under intense scrutiny to the point where the FDA has taken significant steps to limit its access. If you or someone you love has been harmed as a result of using this medication, contact the Avandia injury lawyers at Phillips Law Group today to schedule a free initial consultation.

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