Avandia Heart Risks News

Avandia (Rosiglitazone) Side Effects Lawsuit News:

Rosiglitazone - A lifesaver or killer drug?

-DNA

03/08/2010 - With its alarming rise and high number of diabetes cases, India is called the diabetes capital of the world — the sugar disease is emerging as an enormous health problem in the country. Various studies have shown that the high incidence of diabetes in India is mainly because of sedentary lifestyle, lack of physical activity, obesity, stress and consumption of diets rich in fat, sugar and calories.

Among the various drugs used to treat the disease, one of it is Rosiglitazone, which is used to treat type II diabetes. However, lately there has been some dispute over the effectiveness of the medicine and its side effects. According to US FDA (US Food and Drug Administration), the drug, used by millions of diabetics in India, increases the risk of heart attack.

India has set up a six-member committee of experts on the advice of the country's Drug Technical Advisory Board (DTAB) to review whether the diabetes drug 'Rosiglitazone' needs to be banned from being sold in India.

The committee will consist of a few officials from the Indian Medical Association, Indian Council of Medical Research and the Indian Veterinary Research Institute.

Speaking to DNA, Dr Banshi Saboo, secretary for Research Society for Study of Diabetes in India, (RSSDI) said, "The US FDA has announced a black-box warning on this molecule and is yet to take a final decision on whether to ban the drug from markets.

Thus it has become necessary to review the latest data and decide what India should do."

The US FDA had first sounded an alert against Rosiglitazone's possible side effects in 2007. A study published in the 'New England Journal of Medicine' then found that Avandia (brand name for Rosiglitazone in US) puts users at a 60% greater risk of heart failure and a 29% greater risk of death than other medication.

India's National Pharmaco Vigilance Advisory Committee reviewed the scientific data in January 2008 and in April and recommended to manufacturers of Rosiglitazone to carry a black box warning on its package warning consumers and doctors about its possible health risks.

Dr Deepal Parekh, one of the leading endocrinologists, said, "Avandia once was one of the biggest-selling drugs in the world. After the previous warning, there has been a continued decline in use of Rosiglitazone by physicians in urban India. It is, however, still being prescribed by a few doctors due to lack of knowledge, either as a singular drug or in combination."

The medical experts inform that the ban on this molecule is welcome yet not urgently needed.

Meanwhile, controversy over Rosiglitazone has left patients panicking. Dr Saboo, who had received frantic calls from patients, has clarified that diabetologists are cautious and are decreasing the drug's usage. However, "there are no hard facts against the drug. But many have stopped prescribing the drug since US FDA raised this controversy in 2007," he said.

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