The U.S. Food and Drug Administration is lifting severe safety restrictions on the former blockbuster diabetes pill Avandia, citing recent data suggesting that the much-debated medication does not increase the risk of heart ...
Nov 25, 2013
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(HealthDay)—The development of what might have become a significant diabetes drug has been halted by its maker amid concerns that the medication raises the risk for fractures, kidney problems and heart failure in those ...
Jul 10, 2013
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A re-analysis of the data from a pivotal study of rosiglitazone found no increased risk of cardiovascular events associated with the controversial diabetes drug, according to researchers at the Duke Clinical Research Institute ...
Jun 7, 2013
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US government health experts are recommending changes to safety restrictions on former blockbuster diabetes pill Avandia, in light of a new analysis suggesting that the drug may not increase the risk of heart attack as previously ...
Jun 6, 2013
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GlaxoSmithKline's controversial diabetes drug Avandia, restricted in the US and banned in Europe over concerns it raises heart attack risk, is getting a second look this week by US medical experts.
Jun 5, 2013
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A former blockbuster diabetes pill that was subjected to major safety restrictions in 2010 may be less risky than once thought, according to the latest analysis of the much-debated GlaxoSmithKline drug Avandia.
Jun 3, 2013
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(AP) -- New research sends a stark warning to overweight teens: If you develop diabetes, you'll have a very tough time keeping it under control.
Apr 29, 2012
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For better or worse, a popular class of anti-diabetic drugs does more than lower blood sugar. One known as rosiglitazone (trade name Avandia) has been in the spotlight for its possible link to increased cardiovascular events, ...
Jul 5, 2011
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(AP)—The Food and Drug Administration will hold a meeting in June to reassess the safety of GlaxoSmithKline's former blockbuster diabetes drug Avandia.
Apr 12, 2013
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(AP) — GlaxoSmithKline LLC will pay $3 billion and plead guilty to promoting two popular drugs for unapproved uses and to failing to disclose important safety information on a third in the largest health care fraud settlement ...
Jul 2, 2012
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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.
This text uses material from Wikipedia, licensed under CC BY-SA
