Drug regulator asks GSK for Avandia safety data

Drug regulator asks GSK for Avandia safety data
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First Published: Fri, Jun 08 2007. 03 19 PM IST
Updated: Tue, Jul 31 2007. 08 43 PM IST
The Indian drug regulator says he will now investigate safety concerns on Avandia and Actos, two key diabetes medicines that could potentially be affecting 10 million diabetics in India.
The move is in the wake of US Food and Drug Administration (FDA) putting both under the strictest drug safety warnings amid recent studies linking them to an increased risk of heart failures.
Both GlaxoSmithKline Plc.’s oral diabetes drug, Avandia, and Takeda Pharmaceuticals’ competing medication, Actos, will carry a “black box” warning—the sternest possible warning that the US regulator can issue—to strengthen cautions on the increased possibility of congestive cardiac failures, caused when the heart is unable to pump blood adequately. Both drugs clocked annual sales of over $2 billion (Rs8,200 crore) in US alone last year.
Mint reported on 23 May that versions of Avandia are being sold by Indian companies such as Sun Pharmaceuticals Ltd, Cipla Ltd, Glenmark Pharmaceuticals Ltd and Torrent Pharmaceuticals Ltd, besides Glaxo’s GSK Pharmaceuticals Ltd unit, which sells the drug here as Windia.
FDA Commissioner Andrew von Eschenbach announced his decision at a US congressional hearing on Wednesday, but added that the agency was still reviewing dozens of “often contradictory” studies and analyses, on the drug’s effects on diabetics. He was speaking before the US House Committee on Oversight and Government Reform that is investigating if Avandia could raise patients’ risk of heart attack by roughly 43%, as claimed by a study in New England Journal of Medicine last month. A GSK-backed study later showed that Avandia had a risk profile similar to that of its competitor, Actos.
The Indian regulator, taking note of these steps, told Mint Thursday night that he has begun seeking relevant information.
“I have asked GSK to provide me the information on this molecule and the safety issues will be looked into. Any molecule that is under a cloud will be investigated,” said M. Venkateswarlu, Drug Controller General of India. Any action—a ban or a sterner safety label—will apply to all companies making versions of the drug, he added.
India houses the world’s largest diabetic population at 43 million, which is why as many as 10 domestic drug makers sell rosigliatazone, copycat versions of Avandia, and a dozen—Ranbaxy Laboratories Ltd, Sun Pharma, Biocon Ltd and Lupin Ltd among others—market piogliatazone, sold as Actos by Japan’s Takeda in the US.
“This displays the need to have an effective system of pharmacovigilance, or post- marketing study, in India,” said endocrinologist Dr Anoop Misra, who heads the diabetes department at Fortis Hospital. “Many times, side effects come up after a drug has been in use and we need systems that will aggressively track such occurrences.” Misra suggests that patients go back to their doctors for a possible change of drug regimen.
An adverse directive by the drug controller will hit some of the biggest drug makers in the country.
“We will wait and watch until there are clear directions from the authorities,” said a Sun Pharmaceuticals spokeswoman. Similar sentiments were echoed by a Torrent spokesman and a Glenmark executive.
“GSK India will follow, as always, international and local guidelines with respect to any new regulatory requirements for Windia, which may emerge from the ongoing deliberations with the US Congress and the FDA,” said a company spokeswoman.
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First Published: Fri, Jun 08 2007. 03 19 PM IST
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