Business Daily from THE HINDU group of publications
Friday, Jun 08, 2007
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Business Daily from THE HINDU group of publications Friday, Jun 08, 2007 ePaper |
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Pharmaceuticals Industry & Economy - Health Corporate - Regulatory Bodies & Rulings
P.T. Jyothi Datta
Contentious issues Endocrinologists point out that the threat of a heart attack is not a side-effect that has caught the medical fraternity unaware. The regulatory authority in Europe had called for a similar warning on the drug a year ago.
Mumbai June 7 A fistful of local drug companies such as Cipla, Sun Pharma, Emcure, Aristo, Glenmark and Torrent that make the generic copy of GlaxoSmithKline's diabetes drug Avandia (Rosilglitazone) are waiting for a directive from the Drug Controller-General of India (DCGI) on whether additional safety labelling is required on the medicine. The DCGI will have to indicate whether an additional label warning of a heart-risk is required on generic Avandia, industry representatives told Business Line. The development comes in the light of reports stating that the regulatory United States Food and Drug Administration was in favour of a "black box" warning highlighting the threat of a heart attack. But endocrinologists prescribing the diabetes drug and its generic versions point out that the threat of a heart attack is not a side-effect that has caught the medical fraternity unaware. The regulatory authority in Europe had called for a similar warning on the drug a year ago, said Dr Shashank Joshi, Consultant Endocrinologist with Mumbai's Lilavati Hospital. But that does not mean that the drug has an increased risk of heart attack, the jury was still out on that, he said, referring to an interim outcome of a recent study released earlier this week. It is the meta-analysis of the same study that initially triggered the panic of increased risk of heart attack associated with Avandia. Silent heart attack is a worry associated with diabetes, which was why doctors prescribe a statin and an aspirin to be taken every day with the other medicines, he said. Urging patients not to panic, he said that any change in medication should be done only under a doctor's consultation. With the USFDA submitting a letter at the US Senate, indicating the need for a black box warning, a GlaxoSmithKline spokesperson said that the company would do as directed by the regulatory authority, both globally and in India.
Related Stories: More Stories on : Pharmaceuticals | Health | Regulatory Bodies & Rulings | Glaxosmithkline Pharmaceuticals Ltd
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