30 June 2010
By Rupali Mukherjee
Mumbai, India
In one of the largest studies conducted so far, Glaxo’s anti–diabetes pill rosiglitazone (Avandia) reported an increasing evidence of heart risk, strokes and death, fuelling a debate on this hotly–contested drug, worldwide and in India, and raising questions on whether it should be banned by regulators.
The issue assumes significance in India as rosiglitazone is a widely–prescribed diabetes drug, marketed by at least 10 companies, including Torrent, Dr Reddy’s, Cipla and Glaxo–SmithKline (GSK) India.
Avandia has been under the scanner over the last three years, when one of the first studies reported that it increased heart attack risk in diabetics, after which the US Food and Drug Administration (FDA) issued a safety alert. Subsequently, the drug was marketed with a ‘black box warning’ .
The latest study commissioned by the FDA, and published in the Journal of American Medical Association (JAMA) observed 2,27,571 Medicare beneficiaries aged 65 years or older, who initiated treatment with rosiglitazone or a related drug, pioglitazone, from July 2006 to June 2009, and who underwent follow–up for up to three years.
A total of 8,667 heart attacks, strokes, heart failure and deaths were observed during the study period. Patients who were prescribed rosiglitazone reported 6% more heart attacks as compared to those on pioglitazone; 27% more strokes; 25% more heart failure and 14% more deaths.
Dr David Graham of the FDA, the study’s lead author, said the results are alarming.
Dr Anoop Misra of Fortis Hospitals, Delhi, said, "In view of repeated and decisive data, rosiglitazone has no place in the management of diabetes. In India, this drug should be banned due to less than adequate knowledge of adverse effects by general practitioners in remote areas, and poorly informed patients.’’
A GSK India official declined to speak on the issue, while the drug controller general was not available for comment.
The JAMA study was released two weeks before a crucial US FDA advisory panel meets to decide on the medicine’s future.
In India, the drug is more popular in towns, and widely prescribed in an estimated 20–30% of diabetics.
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