The U.S Food and Drug Administration (FDA) announced Monday that it is lifting certain restrictions against the diabetes drug Avandia. This is in compliance with the recommendations from the panel which ruled out that it doesn't increase the patients' risk to heart attack.
Avandia, with generic name Rosiglitazone, was released in the U.S in 1999 by the pharmaceutical company GlaxoSmithKline for patients with type 2 diabetes. Doctors prescribed it as a stand-alone medication but can also be combined with other drugs such as metformin and glimepiride. However, it was found in 2007 that it increased the patients' risk to heart attack and death. The company received 13,000 lawsuits since then and had settled over 11,500. Health panels recommended a total ban of the drug in the market but the FDA panel disagreed and implemented some restrictions instead.
Researchers who conducted the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) study reported that their findings did not show any correlation between Avandia and the heart attack or death of the patients which contradicted the first report in 2007.
"Our actions today reflect the most current scientific knowledge about the risks and benefits of this drug, said Janet Woodcock, M.D., director of the FDAs Center for Drug Evaluation and Research, in a press release. Given these new results, our level of concern is considerably reduced; thus, we are requiring the removal of certain prescribing restrictions."
FDA will be changing the product label about cardiovascular safety and the Risk Evaluation and Mitigation Strategy (REMS) program. It will also be releasing the results of the study in the public. The current restrictions state that those who prescribe Avandia to their patients should have completed the rosiglitazone REMS program which talks about the cardiovascular risk of the drug.
Once the changes are implemented, Avandia will become accessible to the patients as it will be readily a available in pharmacies.
