(2005; 12 pages)
NAPROXEN - Long-term study indicates cardiovascular risk
USA. The US FDA is alerting healthcare providers to emerging information from a long-term prevention trial, the Alzheimer's Disease Anti- Inflammatory Prevention Trial (ADAPT), that the risk of cardiovascular and cerebrovascular events may increase among patients taking naproxen, a non-steroidal antiinflammatory drug (NSAID).
The US FDA will be analysing all available information from these studies to determine whether additional regulatory action is needed. In the meantime, prescribers are cautioned:
• to carefully weigh the benefits and risks in patients currently on naproxen therapy,
• to always prescribe within the recommended dose of 250-500 mg twice a day and,
• to advise patients to adhere to the recommended daily dose indicated in over-thecounter naproxen preparations.
Several of the cyclooxygenase-2 (enzyme) specific inhibitor drugs (rofecoxib, celecoxib etc.) are currently under investigation for a full understanding of their adverse cardiovascular effects (see WHO Pharmaceuticals Newsletter No. 5, 2004 and section under 'Celecoxib' in this issue). Naproxen, a nonselective over-the-counter NSAID, is also being investigated to determine appropriate regulatory action. The US FDA is planning an advisory committee meeting in February 2005 to discuss the issues surrounding these drugs.
FDA Alert for Health-care Providers (Naproxen), 23 December 2004. Available on the Internet at www.fda.gov