Posted: 09-23-10 Categories:
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FDA: Avandia restricted severly; Europe: Avandia recall

The attorneys at no longer are accepting new Avandia cases.

New FDA Avandia Restrictions Announced

The FDA announced today that it will put tight restrictions on Avandia use. The diabetes drug will be available in the U.S. 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.” The new FDA Avandia restrictions are in response to data linking the Type 2 diabetes medication (generic name “rosiglitazone”) to an increased risk of cardiovascular events, including stroke and heart attack.

FDA restrictions on Avandia use extend to “combination” diabetes drugs that contain rosiglitazone in combination with other diabetes medications. These combination pills include Avandamet (rosiglitazone + metformin) and Avandaryl (rosiglitazone + glimepiride).

“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” FDA Commissioner Margaret A. Hamburg, M.D. said in a statement released today. “We are seeking to strike the right balance to support clinical care.”

Avandia drug company GlaxoSmithKline (GSK) “continues to believe that Avandia is an important treatment ofr patients with type 2 diabetes,” according to Ellen Strahlman, GSK’s chief medical officer.

Avandia Recall in Europe Announced

A European Avandia recall was announced today by the European Medicines Agency (EMA). The suspension of marketing authorization applies to Avandia and all other drugs containing rosiglitazone. The EMA Avandia recall was recommended after it concluded that more severe restrictions would not adequately protect patients from the drug’s increased heart risks:

“In view of the restrictions already in place on the use of rosiglitazone, the [EMA Committee for Medicinal Products for Human Use] could not identify additional measures that would reduce the cardiovascular risk. The Committee therefore concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorisation of the medicines.”

The EMA simply found that benefits of the drug do not outweigh its risks.

The attorneys at no longer are accepting new Avandia cases.

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