The discovery of the life-threatening effects of Vioxx led to its rapid withdrawal by manufacturer Merck under pressure from drug agencies. Now, the successor to the notorious osteoarthritis drug, Arcoxia, is to be banned by the Food and Drug Administration.
Vioxx, a potent, yet purportedly selective, inhibitor of the inflammatory enzyme cyclooxygenase-2 (Cox-2) caused serious cardiovascular complications (heart attack, to put it bluntly) in too many patients once it was released to the wider prescribing world. Pharmaceutical giant Merck hoped that its Arcoxia follow-up in 2004 would fill the niche without being nixed. However doubts about the safety and potential side effects of all Cox-2 inhibitors in the eyes of the FDA has thrown the whole market into disarray.
The FDA’s report on the new drug suggested that its widespread use in treating arthritis could lead to 30,000 heart attacks each year. Merck’s counterargument suggested that the drug has a similar benefit-risk analysis profile as other drugs, such as diclofenac. FDA’s David Graham warned that Arcoxia could be “a potential public-health disaster” because of the increased risk of heart attack and stroke posed by long-term use of the drug. He suggested Arcoxia should be compared with its risk profile with naproxen, against which Vioxx had been compared originally and found wanting.