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FDA finds controversial diabetes drug a risk to heart; sold in India

Hundreds of people taking Avandia,a controversial diabetes medicine,needlessly suffer heart attacks and heart failure each month,according to confidential government reports that recommend the drug be removed from the market....

Written by New York Times | New York/ New Delhi |
February 21, 2010 3:07:44 am

Hundreds of people taking Avandia,a controversial diabetes medicine,needlessly suffer heart attacks and heart failure each month,according to confidential government reports that recommend the drug be removed from the market.

The reports,obtained by The New York Times,say that if every diabetic now taking Avandia were instead given a similar pill named Actos,about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia,intended to treat Type 2 diabetes,is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.

“Rosiglitazone should be removed from the market,” one of the reports,written by Dr David Graham and Dr Kate Gelperin of the Food and Drug Administration (FDA),concludes. Both authors recommended that Avandia be withdrawn.

Meanwhile,experts in India hope that the US report will prompt the Health Ministry to take some “definitive action”. The drug is being prescribed for lakhs of diabetics in India.

“While it has been well recognised that Avandia has side effects,the FDA advisory should lead to definitive action at the Indian level. We can only hope that international scientific knowledge translates into action and the government sets up a committee to review the advisory,” said Dr Srinath Reddy,president of the Public Health Foundation of India (PHFI).

Experts maintain that the use of Avandia in India is not as high as in the US. “Most endocrinologists in India do not prescribe Avandia anymore. The market in India has shifted completely in favour of pioglitazone,which is a better alternative to Avandia,” said Dr Ambrish Mithal,endocrinologist,Indraprastha Apollo Hospitals.

But patients in smaller cities and towns are still on Avandia due to lack of awareness among physicians. “Every day we get two-three patients from the outskirts of Delhi who take Avandia. If the drug is not withdrawn from the market,the authorities must step up the awareness campaign about its side effects,” said Dr Anoop Misra,head of internal medicine,Fortis Hospitals.

The internal FDA reports are part of a fierce debate within the agency over what to do about Avandia,manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients.

The battle has been brewing for years but has been brought to a head by a fierce disagreement over a new clinical trial and a Senate investigation that concluded that GlaxoSmithKline should have warned patients earlier of the drug’s potential risks.

Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign,sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the FDA to issue a warning,and sales plunged. A committee of independent experts found in 2007 that Avandia might increase the risk of heart attack but recommended that it remain on the market,and an FDA oversight board voted 8 to 7 to accept that advice.

“I await the recommendations of the advisory committee,” the agency’s commissioner,Dr Margaret Hamburg,said late Friday night. “Meanwhile,I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved.”

The bipartisan,multi-year Senate investigation — whose results are expected to be released publicly on Monday — sharply criticises GlaxoSmithKline,saying it failed to warn patients years earlier that Avandia was potentially deadly.

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