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The Government has decided to discontinue the use of Rofecoxib formulation in the country with immediate effect. The recommendation to discontinue this drug was taken by the National Pharmacovigilance Advisory Committee after examining its overall benefit-risk profile. The Committee has also recommended cautious use of other selective Cox-II inhibitory drugs in patients suffering from cardiac disorders. The step has been taken in view of the new evidence on risk associated with Rofecoxib.
Rofecoxib, a new class of non steroidal anti inflammatory drug has been in extensive use all over the world including India where a number of local pharmaceutical industries have been marketing the formulations since June, 2000. The drug has been in use since 1999 for relief of signs and symptoms of Osteo-arthritis, Rheumatoid Arthritis, for management of acute pain and treatment of Primary Dysmenorrhea.
Recently, M/s Merck who were conducting a long-term trial for use of the drug for prevention of Adenomatous Polyp, observed that cardiovascular risks including stroke and heart attacks increases significantly in the patients taking Rofecoxib. The firm stopped the trial and decided on 30.9.04 to withdraw the drug voluntarily from all countries.
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