AAOS Bulletin - February, 2005

In the news

Use of Pain Medication/NSAIDs

Recent information about pharmaceutical and over-the-counter (OTC) pain medication used to treat arthritis and other musculoskeletal disorders has caused some concern in the medical community regarding patient use. There currently is conflicting research data on several of the drug agents. The Food and Drug Administration (FDA) will hold an advisory committee meeting on Feb. 16-17, 2005 to discuss the analysis of data on non-steroidal anti-inflammatory drugs (NSAIDs) in response to this controversy. The American Academy of Orthopaedic Surgeons (AAOS) will update its membership with all relevant scientific information as it becomes available.

 

Background

Results from the APPROVe (Adenomatous Polyp Prevention on Vioxx®) clinical trial determined that there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in patients taking Vioxx compared with those taking a placebo. Merck & Co., Inc., the drug’s manufacturer, announced a worldwide withdrawal of Vioxx on Sept. 30, 2004.

On Dec. 9, 2004, the FDA announced label modifications for Bextra®, a Cox-2 inhibitor, requiring that the drug labeling be updated to include warnings for cardiovascular risk and severe skin reactions. A recent study demonstrated an increased cardiovascular risk in patients treated with Bextra compared to placebo. The bolded warning states contraindications for the use of Bextra in patients undergoing coronary artery bypass graft surgery.

On Dec. 17, 2004, the National Institutes of Health (NIH) announced that it suspended the use of a Cox-2 inhibitor, CelebrexTM(celecoxib), for all participants in a large colorectal cancer prevention trial conducted by the National Cancer Institute (NCI). The Adenoma Prevention with Celecoxib (APC) trial was halted after analysis showed a 2.5-fold increased risk of cardiovascular events for participants taking the drug compared to those receiving a placebo.

On Dec. 20, 2004, the FDA announced that preliminary information from the clinical trial involving NSAIDs and patients at risk of developing Alzheimer’s disease showed an increased risk of cardiovascular events with the use of naproxen, when compared to placebo. The FDA advises that patients currently taking over-the-counter naproxen products should carefully follow the instructions on the label. Patients should not exceed the recommended doses for naproxen. Patients also should not take naproxen for longer than 10 days unless otherwise directed by a physician. To read the FDA advisory on limiting use of COX-2 inhibitors go to: http://www.fda.gov/bbs/topics/answers/2004/ans01336.html

Recent Governmental Recommendations

On Dec. 23, 2004, the FDA made the following interim recommendations on NSAIDs:

Physicians prescribing Celebrex (celecoxib) or Bextra (valdecoxib) should consider emerging information when weighing the benefits against risks for individual patients. Patients who are at a high risk for gastrointestinal bleeding, have a history of intolerance to non-selective NSAIDs, or are not doing well on non-selective NSAIDs may be appropriate candidates for Cox-2 selective agents. Individual patient risk for cardiovascular events and other risks commonly associated with NSAIDs should be taken into account for each prescribing situation.

Consumers are advised that all over-the-counter (OTC) pain medications, including NSAIDs, should be used in strict accordance with the label directions. If use of an OTC NSAID is needed for more than 10 days, a physician should be consulted.

In addition, the AAOS recommends the following

The use of medication involves a risk/benefit ratio and should be assessed by physicians in conjunction with their patient and in light of their patient’s specific condition. The AAOS encourages its Fellows to monitor new research and developments in these therapies because new information continues to develop rapidly. Because NSAID use has been associated with gastrointestinal symptoms, physicians may want to consider therapies that provide protection for the stomach, in addition to those that provide for pain relief. Physical therapy, exercise, and acupuncture may also provide pain relief for some patients. To read the press release on the NIH acupuncture study, go to: http://www.nih.gov/news/pr/dec2004/nccam-20.htm

 

Reporting information

The FDA urges health care providers and patients to report adverse event information to FDA via the MedWatch program by phone (1-800-FDA-1088), by fax (1-800-FDA-0178), or by the Internet: http://www.fda.gov/medwatch/index.html.


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