The Hindu Business Line : Safety concerns on GSK's Avandia may have `class effect'

Mumbai May 28 Safety-concerns over GlaxoSmithKline's diabetes drug Avandia, after reports linked it to a potential heart risk, have brought back memories of Merck's arthritis drug Vioxx (Rofecoxib), globally recalled in 2004.

The recall of Vioxx, on heart-related concerns, had cast a shadow on not just Merck's Vioxx and other companies making generic copies of Rofecoxib, but also on the entire family of Cox II anti-inflammatory drugs.

A similar fate may be in store for GSK's Avandia (Rosiglitazone), in that the potential heart-related risk associated with it could extend to the other drugs in its family, pioglitazone as well, observe doctors and pharma industry experts.

GSK has stood by its blockbuster Avandia, the company's second biggest drug grossing $3 billion in sales.

A submission is being prepared for the local regulatory authority, the Drug Controller General, said GSK's spokesperson in India, and doctor queries on the product are being addressed, she added. In India, GSK has been selling Rosiglitazone under the brandname Windia for over 18 months.

And globally, GSK has placed on record its disagreement with the recent New England Journal of Medicine article that linked Avandia to a potential heart-risk.

But, with a preliminary review late last week by the US Food and Drug Administration (FDA) also finding a degree of heart-attack risk linked to Avandia, doctors are beginning to exercise restraint in prescribing this drug, said a diabetologist with a Mumbai-based hospital.

And usually, safety-concerns have a "class-effect", in that it affects the family of medicines, she added.

The diabetes drug is for patients with type 2 diabetes, but diabetologists and endocrinologists have always been aware of the need to use this drug cautiously, because of heart-related risks, she pointed out.

More recently, some patients on Rosiglitazone have been asking their doctors to prescribe a different medicine, after reading about the heart concerns, said another city-based consultant endocrinologist. But, he points-out, there is not enough statistical evidence to establish the risk of the drug.

Cipla's Chief Executive Officer, Mr Amar Lulla, told Business Line that they were watching the developments around Avandia. He too indicated that the safety-concern on Rosiglitazone could extend to others in its family.

Cipla is one of more than 10 drug companies that make generic copies of Rosiglitazone.

The others include Emcure, Orchid, Sun Pharma, Aristo, Torrent and Glenmark.

Sun Pharma's spokesperson indicated that they would wait for clear directions from the Drug Controller and the USFDA. No feed-back has been received on the drug in the local market, the representative said.

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