The Hindu : Karnataka / Bangalore News : Banned drug being sold in city

Online edition of India's National Newspaper
Tuesday, Dec 14, 2004

Karnataka

Karnataka - Bangalore

Banned drug being sold in city

By Sahana Charan

Rofecoxib, the banned drug — Photo: K. Bhagya Prakash

BANGALORE, DEC. 13. A drug banned for its potential to increase the risk of heart attack is available across the counter at several medical stores in the city. The sale of the drug, Rofecoxib, was prohibited by the Drug Controller General of India in October.

The pharmacists seem to be unaware that the drug has been banned after a specific study done abroad indicated that it increased the risk of heart attack. They continue to sell it, often without prescription. Some doctors still recommend its use.

The State Drugs Controller refused to comment on the sale of the drug here.

The anti-inflammatory drug was being used mostly to treat pain in cases of osteoarthritis and conditions affecting the muscles and bones and in menstrual cramps. Its brand names are Rofiz Plus, Roff and Robifax. When this reporter approached some medical stores for the drug, it was easily available without a prescription.

However, a few chemists said they are no longer stocking the drug as it has been banned. "We have sent back the supply to the manufacturers as we were told that the sale of the drug was prohibited," a chemist said.

After reports of the study came out, the pharmaceutical major, Merck and Co. — which sold the drug as Vioxx in the U.S. — withdrew it from the American market. The Food and Drug Administration has acknowledged the withdrawal. In India, most of the major pharmaceutical companies manufacturing the drug have stopped production.

Side-effects

Studies on the side-effects of the drug are being conducted in India as directed by the Drugs Controller General of India.

"Though we have heard that the drug has been banned, it is unclear if the ban is being implemented here. We have stopped prescribing the medicine, which is mostly given for orthopaedic conditions," an orthopaedic surgeon at a reputed hospital in the city told The Hindu .

According to P.S.V. Rao, endocrine and laparoscopic surgeon, Rofecoxib (it comes under the category of Cox II inhibitors) is effective as a painkiller not only for arthritis and certain gynaecological conditions but also for post-surgery pain in patients. The drugs used earlier (Cox I inhibitors) produce side-affects such as ulcers and bleeding in the stomach in some patients. "Most of us have voluntarily stopped prescribing the drug after we came to know about the study. We have not received any direction from the Government to stop giving the drug to patients," Dr. Rao said.

He said that according to the study, only prolonged use of Rofecoxib may increase the risk of heart attack in patients. "Since mostly arthritis patients are recommended long-term use of the drug, only they may be under risk and not those who are prescribed the painkiller for a short period. But a ban on all use was imposed as the drug market in India is largely unregulated and a partial ban may not serve the purpose," he added.

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