FDA Recommends Limited Use of Celebrex, Bextra
Agency Also Advises Consumers on Strict Use of Over-the-Counter Pain Relievers
Dec. 23, 2004 -- The FDA is issuing a public health advisory concerning the use of anti-inflammatory pain relievers, including the Cox-2 inhibitors Celebrex and Bextra, and over-the-counter medications. The advisory includes a recommendation that Cox-2 drug use should be limited to high-risk patients.
Recently released data show that Cox-2 inhibitors (Vioxx, Celebrex, and Bextra) may be associated with an increased risk of heart attack and stroke, says the FDA. They add this risk is greatest when these drugs are used for long periods of time or in very high-risk situations, such as immediately after heart surgery.
Preliminary results from a long-term clinical trial (up to three years) show that long-term use of traditional anti-inflammatory drugs, such as naproxen (sold as Aleve, Anaprox, Naprosyn, and Naprelan), may also be associated with heart attacks.
While the results of these studies are preliminary and conflict with other study data on the same drugs, the FDA is providing this advisory as an interim measure, pending further review of data that continue to be collected.
FDA Recommendations for Celebrex and Bextra
The FDA says doctors prescribing Celebrex or Bextra should consider this emerging information when weighing the benefits against risks for individual patients.
The FDA also advises limiting Cox-2 drug use to:
- Patients who are at a high risk of stomach or intestinal bleeding
- Patients who are unable to tolerate traditional anti-inflammatory drugs
- Patients who are not doing well on traditional anti-inflammatory drugs
One big concern with the traditional anti-inflammatory drugs is that they can lead to potentially serious stomach bleeding from an ulcer. While Cox-2 drugs also carry this risk, the chance of getting an ulcer is lower.
The FDA also says that each patient's heart attack risk should be taken into account when prescribing anti-inflammatory drugs.
Over-the-Counter Pain Medications
The FDA is advising consumers that they should strictly follow instructions on all over-the-counter pain medications. If use of an over-the-counter anti-inflammatory drug is needed for longer than 10 days, a doctor should be consulted. Other examples of over-the-counter anti-inflammatory drugs include ibuprofen (Advil, Motrin) and ketoprofen (Orudis, Oruvail).
It's important to note that acetaminophen (Tylenol) is in a different class of pain relievers and is not an anti-inflammatory drug. However, acetaminophen also has the potential for serious side effects. If taken at doses higher than indicated on the instructions, acetaminophen can lead to liver damage.
The FDA says it will be analyzing all available information from the new studies of Vioxx, Celebrex, Bextra, and naproxen -- as well as any other available data on anti-inflammatory drugs.
An advisory committee meeting is planned for February 2005 which will provide for a full discussion of these issues.