Late in 2006, the FDA approved safety-labeling revisions on Remicade (Infliximab), one of the TNF-a inhibitors approved in the treatment of ankylosing spondylitis.

The first revision concerned adverse reaction that commonly happened within 2 hours of infusion. These were "hypersensitivity reactions" to inactive components of the medication. The reactions included:

• Urticaria - hives
• Dyspnea - shortness of breath
• Hypotension - low blood pressure

The FDA warns that patients who develop a severe hypersensitivity reaction should not continue treatment with Remicade.

The second labeling revision included the increased risk of serious infections (including bacterial sepsis, tuberculosis, and invasive fungal infection). This is a potential problem that the medication has in common with the other TNF-a inhibitors.

Thus, the FDA has recommended that patients be educated about the symptoms of infection and that they be closely monitored after treatment with the drug.

On the other side of the spectrum, a study published in the December, 2006 issue of The Journal of Rheumatology, has found that a Remicade side effect may reduce cardiovascular disease risk. The researches report that patients receiving treatment with Remicade experienced a "sustained increase" in HDL cholesterol.

HDL cholesterol is known as the "good" cholesterol because a high level of it seems to protect against heart attack.

In their study, the researchers conclude that, "Anti-TNF-a treatment in patients with chronic inflammatory arthritides induces a modest, but sustained, increase in serum HDL-C levels, which may have a favorable effect in reducing the cardiovascular risk in these patients."

For more information on the labeling revisions for Remicade, please see:

http://www.fda.gov/medwatch/safety/2006/oct06_quickview.htm
http://www.fda.gov/medwatch/safety/2006/Oct_PIs/Remicade_PI.pdf

References:

J Rheumatol 2006;33:2440-2446.

American Heart Association - http://www.americanheart.org/presenter.jhtml?identifier=180

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