The Hindu Business Line : Drugs Controller allays fears over Vioxx variant

THE Office of the Drugs Controller, Kerala, has sought to dispel doubts over the "discriminatory" use of arthritis drug Rofecoxib (sold as Vioxx in the US), which manufacturers Merck & Co voluntarily withdrew from the American market.

Rofecoxib is a non-steroidal anti-inflammatory drug used to treat pain, particularly in the case of afflictions such as osteoarthritis and menstrual cramps. The Food and Drug Administration (FDA) of the US had subsequently acknowledged the voluntary withdrawal of Vioxx from the market.

This withdrawal was based on preliminary data from a specific study, which indicated an increased risk of adverse cardiovascular events (heart attack and stroke) associated with "long-term" use of Rofecoxib.

There was an increased relative risk for confirmed cardiovascular events beginning after 18 months of treatment in the patients taking Vioxx, Merck had said.

Worldwide sales of Vioxx totalled $2.55 billion last year. Since the introduction of the drug in 1999, 91 million Vioxx prescriptions have been written in the US alone. The drug is sold in some countries under the name Ceoxx.

An official here quoted the Office of the Drugs Controller as saying that Merck does not sell Rofecoxib as Vioxx in India. In any case, the drug is not recommended for administration in patients with kidney, liver or heart complaints. Its use is strictly banned in children.

The voluntarily withdrawal in the US market was necessitated after "sustained use" of the drug gave rise to some side effects. However, the Food and Drug Administration (FDA) of the US has not yet imposed a ban on its own in that country, according to information reaching here from the Office of the Drugs Controller General of India. Studies on side effects, if any, from the use of the medicine are being conducted in India as well.

No reports of side effects from "discriminate" use of Rofecoxib has been reported from any part of the country, a communication from the Drugs Controller General of India said.

In any case, the medicine is recommended strictly based on the prescription of a medical practitioner. In this context, the public need not entertain unwarranted fears about selective use of the drug as recommended by a qualified doctor, the official quoted the Drugs Controller, Kerala, as saying.

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