30 September 2004. Pharmaceutical giant Merck announced today that it was withdrawing rofecoxib, a pain and antiinflammatory drug, from worldwide markets because of safety concerns (see statement from the company website). The nonsteroidal antiinflammatory drug (NSAID) is marketed under various brand names including VIOXX®, and CEOXX®.
Rofecoxib is an inhibitor of cyclooxygenase 2 (COX-2), an enzyme that is crucial for synthesis of certain prostaglandins, hormone-like molecules that mediate a variety of physiological processes, including the inflammatory response. Rofecoxib has been investigated in clinical trials for its ability to prevent or slow the progression of Alzheimer disease (see ARF related news story), and it has been used worldwide to treat pain and inflammation, particularly in those suffering from arthritis.
The drug has been withdrawn because of concerns that it could cause serious cardiovascular damage leading to heart attack or stroke. These side effects were uncovered in a clinical trial for the drug as a treatment for colorectal polyps.
How this affects other COX-2 inhibitors is uncertain at present. According to the Food and Drug Administration’s acting commissioner, Dr. Lester M. Crawford, the FDA will closely monitor other drugs in this class for similar side effects. This is of particular interest to the Alzheimer community because celecoxib (better known as Celebrex®), also a COX-2 inhibitor, is currently being used in ADAPT, the Alzheimer's Disease Anti-inflammatory Prevention Trial (see ARF related news story), which has already itself proven controversial (see ARF related news story).—Tom Fagan.