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FDA issues public health advisory on COX-2 drugs

Pharmacy Regulation Resource, December 29, 2004

The FDA on December 23 issued a public health advisory for non-steroidal anti-inflammatory drugs (NSAIDs), including the much-maligned COX-2 inhibitor class.

Healthcare providers should take three interim steps to reduce the risk of adverse events with NSAIDs until further data is collected, the FDA said. The steps include the following:

• Physicians prescribing Celebrex (celecoxib) or Bextra (valdecoxib) should consider new clinical-trial data when weighing the benefits against risks for individual patients. Patients who are at a high risk of gastrointestinal bleeding, have a history of intolerance to non-selective NSAIDs (naproxen, sold as Aleve or other brand-name or generic drugs), or are not doing well on non-selective NSAIDs may be appropriate candidates for COX-2 selective agents.
• Prescribers should take into account individual patient risk for cardiovascular events and other risks commonly associated with NSAIDs.
• Prescribers should advise patients that all over-the-counter pain medications, including NSAIDs, should be used in strict accordance with the label directions. Patients should consult a physician if an over-the-counter NSAID is needed for more than 10 days.

The public health advisory came after data from clinical trials showed the COX-2 drugs such as Vioxx, Celebrex, and Bextra may be associated with an increased risk of heart attack and stroke, especially when used for a long period of time or immediately after heart surgery.

The FDA also disclosed in late December that a long-term clinical trial showed prolonged use of naproxen may be associated with an increased cardiovascular risk.

Go to www.fda.gov/bbs/topics/ANSWERS/2004/ANS01336.html to view the public health advisory and other related materials.

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