Govt looking into Pfizer drug pullout

After Rofecoxib, another painkiller of the same class of drugs has been withdrawn by its Pfizer in the US owing to risks of deadly skin reactions and the government here said it has initiated a "decision process" on the issue.

"It is in our knowledge and a decision process has been initiated," Drug Controller General of India Ashwani Kumar said without elaborating what it meant.

Drug experts favoured withdrawal of the drug, Valdecoxib, saying when the company itself had agreed to do so in the US and European countries, there was nothing much to be done by the government.

Valdecoxib is manufactured by Pfizer and comes under the category of Cox-II inhibitors, the same class to which another controversial drug, Rofexocib, belongs.

Rofecoxib was banned by the government following its ban in other countries.

Ranjit Roy Chaudhury, member of the official national pharmaco vigilance committee, said that "last time we had withdrawn Rofecoxib. We will consider Valdecoxib as well."

The committee is examining all the Cox-II inhibitors, he said adding the decision may be taken fast as in the case of Rofecoxib, when government had acted fast.

However, other experts said since the company itself had withdrawn the drug, a simlar decision should also be taken by the government here.

"How could be a drug harmful in the US and Europe and useful in India," C M Gulati, from the monthly index of medical specialities said. Valdecoxib is sold under Pfizer's brand name Bextra in the US.

The company withdrew the drug following directions by the US Federal Drug Authority (FDA) and the European Medicine Evaluating Agency (EMEA).

The reasons cited by the two were reports of "serious unpredictable and potentially life threatening skin reactions including death, lack of adequate data on safety on heart on long term use, and lack of any evidence for Valdecoxib being superior to other similar drugs."

The drug is commonly used for pain, mostly musculo-skeletal pain such as arthritis and post-operative pain, Gulati said. The total sale of all Cox-II inibitors - Valdecoxib, Celecoxib, Etoricoxib and Rofecoxib (now banned) - was about R90 crore per year in India, he said.

Following coming to light of ill effects of Rofecoxib on heart, there are apprehensions about all the Cox-II inhibitors.

Ninety per cent of sale of Valdecoxib in India is sold under the brand name Valus, produced by Glenmark. It is also sold as Valcox by Unichem, Vah by Nicolas Piramal, Vacox as Alembic, Valdixx by Cipla and VX2 by Novartis, he said.

US government also ordered new warning labels for Cox-II inhibitor drugs. The new warning label would also be required for Ibuprofen. The company will also suspend Bextra sales in the European Union and is holding talks with regulators in other parts of the world, reports said.