The Hindu : Front Page : Diabetes drug needs additional warnings

Online edition of India's National Newspaper
Thursday, Aug 02, 2007
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Diabetes drug needs additional warnings

Sarah Hiddleston

CHENNAI: The Drugs Controller-General of India is awaiting an announcement from the United States Food and Drugs Administration (FDA) on whether to make an independent assessment of the health risks of a drug widely used to treat a common form (type 2) of diabetes, which affects 32 million people in India.

Avandia, marketed by GlaxoSmithKline in India as Windia, was found to increase the risk of heart failure by an FDA advisory committee of 23 experts examining evidence of clinical trials in Washington on Monday. However, they also concluded that it should remain available in the U.S. market with an additional warning because the studies were not clear enough to merit further regulatory action.

Dr. Hasit Joshipura, GlaxoSmithKline’s Managing Director in India, said that the DCI had been informed of the outcomes of the meeting, and that GSK will wait for directions from the FDA and the DCI. He said that GSK would make whatever changes might be required in labelling.

A.B. Ramteke, Deputy Drugs Controller, said the DCI’s decision would depend on the announcement from the FDA. Advice for diabetes patients taking the drug may be issued.

Advice for more than 10 generic companies making the drug will also be given.

Concerns about the drug were raised in May when leading U.S. cardiologist Dr .Steven Nissen published a study in the New England Medical Journal linking it to a 43 per cent increase in the risk of heart failure in patients. Subseque ntly, scientists from the University of East Anglia, U.K. and Wake Forest University, North Carolina, U.S., analysed data pooled from 78,000 patients in the U.K. and the U.S. taking Avandia and Actos, a drug in the same class made by the Japanese firm Takeda.

The results, which were published in Diabetes Care, showed that one in every 50 patients could be hospitalised for heart failure after 26 months of taking the drug.

Dr. D. Shantharam, Senior Consultant Diabetologist, Apollo Hospitals, Chennai, said that the hospital had not seen any side effects of this nature in their patients.

He however said that they will be now monitoring patients more closely.

He called for controlled studies in India to see if the Indian body responded differently. He said that it was difficult to determine the clinical relevance of the New England study because the trials conducted were only significant when pooled and not individually.

For the time being, he said, he was “against withdrawal since the drug has beneficial effects in preventing the onset of diabetes in pre-diabetics and improving insulin resistance, which is the common denominator for blood pressure, dyslipidemia, diabetes and coronary artery disease in metabolic syndrome.”

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