The Hindu : Kerala / Thiruvananthapuram News : Drugs safe, says doctors’ body

Online edition of India's National Newspaper
Monday, Jul 30, 2007
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Kerala

Kerala - Thiruvananthapuram

Drugs safe, says doctors’ body

C. Maya

Thiruvananthapuram: As controversy rages over the safety concerns of the widely-prescribed diabetes drugs, rosiglitazone and pioglitazone (generic names), physicians here have warned patients not to stop the medicines on their own.

The safety warnings on the two drugs, which are cheap and popular in India, were issued by the U.S. Food and Drug Administration (FDA) last month after cardiologists linked the drug to an increased risk of heart failure.

The controversy, which broke out in May-June after the revered New England Journal of Medicine (NEJM) published a series of articles on the drugs’ safety concerns, is viewed with much concern by physicians in Kerala too as the State has a huge burden of patients with diabetes and cardiovascular problems.

International news agency Reuters reported that the FDA advisers would meet on July 30 again to discuss the safety of the drug.

However, the nation’s apex body of physicians, Association of Physicians of India (API), have assured patients that there was no public health emergency and that patients need not panic. The API has taken the stand that in the absence of conclusive scientific evidence, the drug may continue to be prescribed on a case-to-case basis, after considering patient safety and therapy issues.

The drugs, rosiglitazone and pioglitazone, have been widely in use in India as these have been found to render good glycemic control, which according to the API, is often unmatched by any other class of drugs.

The drugs have been found to be effective enough to delay a Type-II diabetes patient’s treatment ‘progress’ towards the use of insulin, a prominent physician in the city said. The drugs are ideal for the Indian situation too as these are cheap unlike insulin or other new drugs in the market. However, the drugs have been in the eye of a storm since May when Steven Nissen, a noted U.S. cardiologist, published a pooled data of 42 earlier clinical trials in NEJM, which showed that the drug increased the risk of heart failure by 43 per cent. It was Dr. Nissen who had issued the first warnings on the drug, Vioxx (rofecoxib, an anti-inflammatory drug), which was linked to an increased risk of heart attack and stroke. “Clinicians here feel that the benefits of the drug outweighs the risks. Many Net-savvy diabetic patients would be worried now because many of them would be taking either of the drugs in combination with other drugs such as statins. However, they should consult their physician before changing their drug regimen,” said Sreejith N. Kumar, a physician here.

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