11 November 2010
By Teena Thacker
New Delhi, India
The drug, prescribed worldwide for three decades, has been linked in research over the past few years with increased cardiovascular events like cardiac arrests and strokes. Pharma giant Abbott Laboratories has withdrawn products containing sibutramine from the US, Australian, Canadian and other markets.
"With the innovator withdrawing the drug it cannot be allowed to be in the market now. After having consultations with experts, we will most likely recommend to the Health Ministry to ban it," Dr Surinder Singh, Drug Controller General of India, told The Indian Express on Thursda told The Indian Express on Thursday. The DCGI's meeting with experts is scheduled for tomorrow.
Sources said the DCGI has been consider ing suspending the drug from the market, and had been waiting for the findings of a manufacturer–funded "scout trail" that began in 2003, involving some 9,000 people in 16 countries.
The study tracked the effects of sibutramine in people who had hypertension, or had suffered a heart attack or stroke. "The ini tial results of the trails showed that sibutramine was associated with more deaths in people with these problems," said a source.
Dr Anoop Misra of Fortis Healthcare said sibutramine is frequently prescribed for obese diabetics in India. "If 20–30 per cent are receiving some drug for obesity, 90 per cent would be on sibutramine," he said, adding, "personally I feel that it is a very good drug for people under the age of 40. Six months of use can re sult in a loss of 6–10 kg on average."