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Journalism of Courage
Pharmaceutical giant, Merck, has decided to voluntarily withdrawing Vioxx (chemical name rofecoxib), one of the largest-selling painkillers in the world, after a study showed increased risk of heart attack and stroke. And, India, which has a Rs 100 crore annual market for the medicine, is reviewing the issue.
According to the Drug Controller General of India, a decision in this regard is likely to come in a week.
In a press release, the Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal of Vioxx — a non-steroid anti-inflammatory drug (NSAID) — and also issued an advisory to the patients to consult a physician for alternative medication.
The medicine is being produced by all the major pharma companies in India and about 40 brands are available in the market. ‘‘We have received the news and are looking at the facts. Since the withdrawal is voluntary and adverse effects have been reported in long-term use, we will take a decision in a week’s time,’’ said Ashwani Kumar, Drug Controller General of India.
Merck decided to withdraw Vioxx from the market after the Data Safety Monitoring Board — overseeing a long-term study of the drug — recommended that the study be stopped as there was an increased risk of cardiovascular events, including heart attacks and strokes, among patients using the drug.
