The United States FDA (the federal Food and Drug Administration) has announced that it will significantly restrict access to the diabetes drug Avandia for new patients. 
The pharmaceutical manufacturer of the drug, GlaxoSmithKline (GSK), is now required by the FDA to develop a “risk evaluation and mitigation strategy,” or “REMS” for to restrict access to Avandia. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications. Current users of Avandia can continue using the medication if they choose to do so, but should be aware of the significant risks involved.
The drug known as rosiglitazone, or by its brand name Avandia, or the combinations with Avandia of Avandamet or Avandaryl, used in managing and treating Type 2 diabetes mellitus has been the subject of personal injury lawsuits and continuing medical criticism across the United States. The use of this drug, Avandia (rosiglitazone), has been associated with an increased risk of serious cardiovascular events, such as heart attacks, congestive heart failure, stroke and resulting deaths.
The FDA has been continuing to investigate these adverse effects and evaluate the use of this medication. In July 2010, a joint advisory committee met with the FDA to further advise them about the effects of Avandia/Avandamet/Avandaryl (rosiglitazone) use, with the majority of the committee suggesting that federal action be taken to restrict or eliminate use of the drug due to the significant cardiovascular risks and death.
Now the FDA has made a decision to restrict access to that drug for only new patients and requires that these new patients be informed about the cardiovascular safety concerns associated with this drug. Physicians will also have to attest to and document their new patients’ eligibility for the medication and new patients will have to acknowledge they understand the risks and potential serious side effects.
If you or someone you know has taken this drug and suffered an injury or death as a result, please contact our firm for a free consultation and information regarding a potential claim. Pearson Randall, Schumacher & LaBore, P.A. is a law firm that practices in the areas of personal injury, consumer protection and national pharmaceutical litigation, and is working on issues relevant to this case. To contact the author, Attorney Nicole L. Kreklau directly, please send an email to firstname.lastname@example.org, or call any of the attorneys at Pearson, Randall, Schumacher & LaBore, P.A. at 612-767-7500 or toll-free at 800-774-0757.
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