In a few weeks from now rofecoxib, a 1999 molecule of Merck for arthritis, will be completely withdrawn from the world markets. According to Merck, it found that the molecule posed an increased risk of cardiovascular events on patients who are on use of the drug more than 18 months. The drug has to be taken on long duration. Now, although Merck withdrew its brand Vioxx, worldwide early this month, over a hundred other brands of the molecule are still being sold in India, Pakistan and in a few markets where there are no product patent laws. The drug was approved for marketing in India on June 26, 2000 and the current market size is Rs 91 crore. In India, Drug Controller General of India has been advised by National Pharmacovigilence Committee to effect a total recall of rofecoxib formulations soon after Merck's decision. A notification banning the sale of the drug in India from the office of DCGI is a just a formality now. Some companies like Micro, Juggat Pharma and Unichem announced withdrawal of their brands last Tuesday. A day after Ranbaxy also announced recall of its Rs 13 crore Rofibax. With the imminent order from DCGI or by way of more voluntary withdrawals by other companies, the sale of this molecule will come to an end in India very soon. Pakistan with as many as 30 brands now in the market should also be under pressure to recall the molecule sooner or later.

Adverse drug reaction of rofecoxib is just not the only reason for Merck to withdraw its 2.5 billion dollar brand from the market. The company could have continued the sale of Vioxx by adding label warnings especially when there was no direction from the US FDA against marketing the drug. What actually prompted Merck to withdraw Vioxx was a string of lawsuits against the company. An Oklahoma lawsuit on September 30 charged Merck for misleading patients about the safety of the drug. The suit alleged Vioxx raised the risk of heart attack, blood clots and other cardiovascular events which can lead to injuries and death. According to a leading law firm in the US, there are 58 cases pending against Merck in states including New Jersey and Virginia involving patients suffered stroke or heart attack after taking the drug. It is the prospects of meeting huge payments as compensation to patients in such cases that motivated Merck to withdraw. Probably, these payments could easily wipe out whatever it earned from the product during the last five years. Merck's case is probably third prominent lawsuit in the US against pharmaceutical companies during this year. The first suit was against Pfizer for its off label promotion of Neurontin in May and the second was against GSK in June for concealing negative information about Paxil, its antidepressant drug. What is becoming evident from these frequent litigations is that pharmaceutical companies cannot anymore get away with their lax attitude towards drug safety and consumer health.