FDA restricts Glaxo’s Avandia, EU bans the drug


Avandia, an anti-diabetic drug has been in news for a while due to causing severe heart failure side effects. Nearly 24 million Americans, or about 8% of the U.S population, live with diabetes. Type 2 diabetes accounts for more than 90% of those cases, according to the National Diabetes Information Clearinghouse.

Avandia was launched by GlaxoSmithkline in 1999 to treat type 2 diabetes, and sales of the drug exceeded $3 billion by 2006. After initial reports of potential heart risk, yearly Avandia sales in the U.S. dropped from 13.3 million prescriptions in 2006 to 2.6 million in 2009, according to the pharmaceutical firm IMS Health.

In July 2010, the FDA held hearings evaluating the drug’s safety. Thirty three members committee determined that Avandia increases the risk of heart problems compared to other diabetes medications. Finally, FDA announced today that it will allow the use of the drug but with some restrictions. The new restrictions allow patients to take Avandia who have already been using the drug for a long time, but now patients have to sign a consent stating that they understand the potential risks involved. 

Dr. Joshua Sharfstein, FDA principal deputy commissioner said “Patients will only be allowed to use Avandia if they acknowledge and document the risk of this drug.

Under the new restrictions, doctors may only consider prescribing Avandia to patients if they have exhausted all other medications, including the drugs market competitor, Actos and unable to find the better solution than Avandia.

style="text-align: justify;">On the decision of FDA, Steven Nissen, a cardiologist at the Cleveland Clinic who published a study on Avandia in the New England Journal of Medicine said that “I think it’s a reasonable course of action and compromise. It will limit 99% of its use.”

In contrary to FDA, European Medicines Agency, which is the FDA’s European counterpart announced it will stop marketing of the drug (Avandia) altogether.

Though FDA’s decision restricts the use of the drug up to some extent, but doctors have to be careful for their patients. In most of the cases heart diseases and diabetes co-exist. Many people might not have heart disease when they start the therapy, but it can develop over the period of time due to the family history or other reasons. Many developing countries have no strict regulations for the drugs. I hope doctors in these countries will follow the same guidelines as issued by FDA, if they are prescribing Avandia or any other generic versions of the drug.

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Source: abcnews

8 Responses

  1. Ben Meeks says:

    At the recent American Diabetes Association Science Conference in Orlando Florida Albert Einstein Medical College presented the results of two human trials using Biotivia Transmax in place of Avandia. Transmax, a purified form of the natural substance resveratrol which is found in grape skins, performed extraordinarily well in lowering blood glucose, improving glucose tolerance, increasing insulin sensitivity and enhancing mitochondrial function, all with no adverse effects or toxicity. It is time this safe and reasonably cheap natural compound be taken seriously by all diabetes 2 sufferers.

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