Rosiglitazone is an antidiabetic drug in the thiazolidinedione class of drugs. It works as an insulin sensitizer, by binding to the PPAR receptors in fat cells and making the cells more responsive to insulin. It is marketed by the pharmaceutical company GlaxoSmithKline (GSK) as a stand-alone drug (Avandia) and in combination with metformin (Avandamet) or with glimepiride (Avandaryl). Annual sales peaked at approximately $2.5bn in 2006, but declined after reports of adverse effects. The drug's patent expires in 2012.
Some reports have found rosiglitazone is associated with an increased risk of heart attacks, but other reports have not found a statistically significant increase. Concern about adverse effects has reduced the use of rosiglitazone despite its sustained effects on glycemic control. The drug is currently the subject of over 13,000 lawsuits against GSK. As of July 2010, GSK has agreed to settlements on more than 11,500 of these suits.
The drug is controversial in the U.S. Some reviewers have concluded that rosiglitazone caused more deaths than pioglitazone (Actos), and have recommended rosiglitazone be taken off the market, but an FDA Food and Drug Administration panel disagreed, and it remains on the market in the U.S., subject to significant restrictions. From November 18, 2011 the federal government will not allow Avandia to be sold without a prescription from certified doctors. Patients will be required to be informed of the risks associated with the use of Avandia, and the drug will be required to be purchased by mail order through specified pharmacies.
In Europe, the European Medicines Agency (EMA) recommended in September 2010 that the drug be suspended from the European market. However, patients currently taking rosiglitazone are advised to discuss alternative options during their next physician appointment.
In the UK, Diabetes UK announced, "People currently taking all forms of the recently suspended drug Avandia (Rosiglitazone) have until 21 October to be reviewed and transferred onto an alternative treatment".
In New Zealand, rosiglitazone (Avandia) is to be withdrawn from the market before April 29, 2011 after concern about its make an elevated risk of cardiovascular events. Patients should discuss alternative treatments with their doctor as soon as possible, but to continue taking the drug in the meantime.
As reported by Medscape/Heartwire 23 September 2010,medscape the EMA has recommended the suspension of the marketing authorizations for all rosiglitazone-containing antidiabetes medications licensed in the EU—Avandia, Avandamet, and Avaglim.
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