Entries in Avandia (4)


FDA to Enforce New Restrictions on Diabetes Drug Avandia

Jupiterimages/Thinkstock(WASHINGTON) -- Pharmacies will no longer sell the diabetes drug Avandia.  The U.S. Food and Drug Administration announced that new restrictions on the controversial drug will take effect Nov. 18, reports HealthDay News.

The FDA's policies will only allow the drug to be accessible to patients practicing safe use of Avandia and who have been unsuccessful in controlling their blood sugar levels with other diabetes medications.  Patients must also qualify for the drug through enrollment in a special program, the FDA says.

The new restrictions will also apply to the combination drugs containing rosiglitazone -- Avandamet (combined with metformin) and Avandaryl (combined with glimeperide), according to HealthDay News.

Copyright 2011 ABC News Radio


Actos May Prevent Type II Diabetes

Jeffrey Hamilton/Thinkstock(AUSTIN, Texas) -- Much attention has come to the use of glitazones, a class of drugs for the treatment of diabetes, especially in light of the Avandia (rosiglitazone) black box warnings.  Avandia is associated with an increased risk of heart attacks and has been taken off the market in Europe. However, Actos (piolitazone), has fewer side effects and is still used as a therapy for type 2 diabetes. 

In this study, conducted by University of Texas Health Science Center and published in the New England Journal of Medicine, over 600 participants who have elevated blood sugar, a risk factor for developing type 2 diabetes, were given either Actos or a placebo and then followed for 2.4 years.  Results of the study show participants in the Actos group were 72 percent less likely to develop diabetes than those taking placebo. 

This is a modest improvement over lifestyle change alone, which can lead to a 58-percent decrease in progression to diabetes.  Patients in the Actos group also had slightly lower blood pressure, less plaque buildup in arteries, and an improvement in cholesterol.  However, patients taking Actos had more weight gain and leg swelling than those on placebo. 

It is not clear weather this medication will benefit patients in the long term or actually decrease complications from diabetes down the line. 

Copyright 2011 ABC News Radio


New Analysis Reinforces Links Between Avandia and Heart Problems

Medioimages/Photodisc/Thinkstock(NORWICH, England) -- In 2010, the FDA announced that it would significantly restrict the use of Rosiglitazone, popularly known as Avandia, a drug used to treat type 2 diabetes after the drug was associated with a higher risk of heart attacks.

Now, a new review study from the University of East Anglia in Norwich, England adds more weight to the mounting evidence of the drug being associated with heart problems.

Researchers from the U.S. and UK analyzed the results of 16 studies that directly compare the risk of heart problems for two drugs popularly known as Actos and Avandia. Both the drugs are used to treat type 2 diabetes.

The team found that, compared with Actos, Avandia was associated with a slightly increased risk of heart problems.  However, the researchers noted that both drugs belong to the same class and are known to be associated with heart problems.

While the drug remains on the market in the United States, the use of Avandia has been suspended in Europe since September 2010.

Copyright 2011 ABC News Radio


Diabetes Drug Will Be Restricted Due to Heart Risk Concerns

Photo Courtesy - ABC News(NEW YORK) -- The U.S. Food and Drug Administration announced Thursday it will significantly restrict the use of the diabetes drug rosiglitizone, popularly known as Avandia, after subsequent reviews of the drug suggest a higher risk of heart attack.  The FDA will require stringent monitoring requirements for the drug's manufacturer, GlaxoSmithKline, under the agency's Risk Evaluation and Mitigation Strategies.  Under the new restrictions, patients currently taking Avandia will be able to continue doing so, but will have to sign a consent form stating they understand the potential risks involved.  "Patients will only be allowed to use [Avandia] if they acknowledge and document the risk of this drug," said Dr. Joshua Sharfstein, FDA principal deputy commissioner.  Doctors may only consider prescribing Avandia to patients if they have exhausted all other medications, including the drug's market competitor, Actos.

Copyright 2010 ABC News Radio

ABC News Radio