FDA reviewing Avandia, rosiglitazone and cardiovascular safety

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The U.S. Food and Drug Administration (FDA) is reviewing data, submitted in August 2009, from a large, long-term clinical study on possible risks with the diabetes drug, Avandia (rosiglitazone).

The clinical study, called the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes or RECORD study was designed to evaluate the cardiovascular safety of rosiglitazone, a medication used to treat type 2 diabetes mellitus.

In addition to the RECORD study, a number of observational studies of the cardiovascular safety of rosiglitazone have been published. FDA has been reviewing these on an ongoing basis.

FDA is now reviewing the primary data from the completed RECORD study, conducting follow-up audits, and reviewing additional studies. This work is ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time.

Once FDA completes its review of the data from the RECORD study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010. At that meeting, the Advisory Committee will provide an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes.

When prescribing rosiglitazone, healthcare professionals should follow the recommendations in the drug label. Patients should continue taking rosiglitazone unless told by their healthcare professional to stop. Patients who are concerned about the possible risks associated with using rosiglitazone should talk to their healthcare professional.

FDA previously communicated to the public about the possible association between rosiglitazone and increased cardiovascular risk in a 2007 safety alert1. The agency also sought advice from external experts at the July 30th 20072 joint meeting of the FDA Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. The RECORD study data represent the only new information from a completed randomized, controlled clinical trial of rosiglitazone received by FDA since the 2007 announcements.

The RECORD study was designed to evaluate the cardiovascular safety of rosiglitazone, which is consistent with FDA’s December 2008 Guidance for Industry3 recommending that manufacturers of new treatments for diabetes carefully design their clinical trials to include an evaluation of cardiovascular safety. The RECORD study will be evaluated in the context of this recent Guidance.

Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. It is also available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

FDA recommends that patients currently using rosiglitazone:

– Not stop taking their medication without talking with their healthcare professional.

– Discuss any questions or concerns they have about rosiglitazone with their healthcare professional.

– Read the Medication Guide that comes with each rosiglitazone prescription to better understand the risks and benefits of their medication.

– Report any side effects with rosiglitazone to FDA’s MedWatch program using the information at the bottom of the page.

Source: U.S. Food and Drug Administration, USA

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