Hundreds of people taking the diabetes drug rosiglitazone suffer heart attacks and heart failure each month, a US government report has concluded, recommending the drug be removed from the market.
The FDA report said that if every diabetic taking rosiglitazone had been prescribed a similar drug called Pioglitazone, 500 heart attacks and 300 cases of heart failure would have been averted in the US every month, New York Times reported on Sunday, quoting the confidential Food and Drug Administration report.
While GSK holds the patent for rosiglitazone in the US (brand name Avandia), the drug is prescribed and sold under 10 different brand names to 8 million people in India, where it was launched in 2001.
It shot to popularity on prescription pads because, besides regulating insulin and blood sugar, the drug also has a favourable impact on lipids (blood fats such a cholesterol), coagulation and fat in liver, besides blood sugar.
“Rosiglitazone is a third-line drug prescribed after the first two lines of treatment — such as metformin and sulfisoxazole — become ineffective.
In India, it is even prescribed as a drug that prevented diabetes,” said Dr Anoop Misra, head of the department of endocrinology, Fortis Group of Hospitals.
Available in 2,4 and 8 mg tablets, rosiglitazone belongs to the thiazolinedione class of drugs and is initially prescribed to diabetics in a single 4 mg dose or in divided doses, which can go up to 8 mg a day in single or divided doses.
Insulin is prescribed after the thiazolinedione class of drugs stop having effect on blood sugar levels.
“Drugs to prevent diabetes are not required, especially as a healthy diet and regular exercise can help achieve a similar reduction in incidence,” he said.
Rosiglitazone was once one of the largest selling drugs in the world, before a 2007 study published in The New England Journal of Medicine found it harmed the heart and prompted the FDA to issue a warning.