Pharmaceutical companies may need a watch dog during the post-marketing phase of their products, according to a new investigation.
Researchers from the University of Washington, Seattle, recently reviewed internal files from the makers of the cholesterol-lowering drug cerivastatin, a cholesterol-lowering drug removed from the market in 2001. Their study shows the manufacturing company may have known about the drug’s adverse effects even after it was launched. The company neglected to disclose this information to physicians or patients in a timely manner.
Documents indicate that within 100 days of launching cerivastatin, patients reported experiencing a breakdown of skeletal muscle tissue, which caused pain, weakness, renal failure, and, in some cases, death.
Despite this information, the company did not issue a warning to the public for more than 18 months.
Bruce M. Psaty, M.D., Ph.D., co-author of the study, says, “The history of cerivastatin illustrates a flaw in the current U.S. system for SASR (suspected adverse drug reactions) reporting and monitoring. When serious adverse effects such as rhabdomyolysis (breakdown of muscles fibers) appear after marketing, defects in the safety-surveillance system can, depending in part on the response of the pharmaceutical company, pose a threat to the health of the public.”
Unlike the United States, officials in Europe re-review drug approvals every five years, which encourages companies to launch phase 4 trials and remove unsafe drugs from the market. The European government also collects a post-marketing fee that funds surveillance efforts.Researchers suggest this system in the United States to further ensure the safety of patients.
SOURCE: The Journal of the American Medical Association, 2004; 292:2622-2631