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Diabetes Drug Avandia Faces Stricter Regulation


The U.S. and European drug regulatory agencies recently issued rulings that restrict the use of the diabetes drug Avandia, which studies show increase the risk of heart attack and stroke as it controls blood sugar levels.

Avandia was once one of the most popular drugs to treat Type 2 diabetes in the United States. But sales fell sharply in 2007 after a study linked the drug to cardiovascular problems.

Now the European Medicines Agency plans to remove the drug from the market and the U.S Food and Drug Administration in the United States intends to restrict its use only to patients for whom all similar medications have failed.

Dr. Yasser Ousman, an endocrinologist in Fredericksburg, Maryland, prescribes Avandia for some patients in combination with other drugs. "It is quite effective in improving the blood sugar, in normalizing the blood sugar or delaying the occurrence of diabetes in these individuals," he said.

Avandia is marketed in more than 110 countries and the European ruling will affect 30 of them. The new regulations limiting Avandia's use in the United States take effect in the next few months.

Dr. Steven Nissen, a cardiologist at the Cleveland Clinic in Ohio, published the study first linking Avandia
to a higher risk of heart attack. And a panel of U.S. experts that evaluated the drug again this year recommended restricted access.

Dr. Nissen says he is happy with the decision to better regulate Avandia, but not with how long it took the Food and Drug Administration to limit the drug's use. "I will sleep better tonight, but I will not sleep until I know that we've have improved how we handle these kinds of problems in the United States. We've got to fix the FDA," he said.

Avandia's Britain-based maker, GlaxoSmithKline, says it continues to believe the drug is an important treatment for patients with Type 2 diabetes. And Dr. Ousman is one of those who is not convinced by Dr. Nissen's research.

"I think when you look at the information and the statistics from the initial study, the initial paper by Dr. Nissen in 2007, the increase in the risks of heart attacks is actually small," Nissen said.

Dr. Ousman argues that Avandia's rival drug Actos, or for that matter many over the counter drugs - aspirin, ibuprofen, acetaminophen or paracetamol - can be toxic if used improperly. "If you look at the large studies, that were published over the last several years, including a large number of patients comparing Avandia to a placebo or other drugs, there was actually no increase in that risk. That risk was based on smaller studies," he said.

The American Diabetes Association supports the Food and Drug Administration's decision not to totally pull Avandia off the market, but consumer advocates call for a ban.

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