FDA Issues Warning On Arthritis Drugs Over Deaths

By Alice Turner
21:11, September 7th 2008
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FDA Issues Warning On Arthritis Drugs Over Deaths

The U.S. Food and Drug Administration issued a statement which highlights that manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, to better highlight the risk of developing fungal infections. The FDA found that several patients with invasive fungal infections have died.

Humira, Cimzia, Enbrel, and Remicade are tumor necrosis factor alpha blockers (TNF-alpha blockers) which are immunosuppressors, reducing the activity of a person's immune system, thus possibly exposing them to a higher risk of various diseases. They are used to treat diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease.

The FDA said that it might be needed to stop taking the medication if such an invasive fungal infection occurs, until the infection is treated. Not taking the immunosuppressors greatly enhances the body's ability to deal with the fungi.

In June, Scandinavian scientists found that the risk of developing rheumatoid arthritis was 50 percent lower for those who drank the equivalent of five glasses of wine a week compared with those who drank the least. The good news is that moderate alcohol consumption cut the risk of rheumatoid arthritis even in the participants who smoke or have a genetic predisposition to the disease.

Rheumatoid arthritis is an auto-immune disease caused by a malfunctioning immune system. How can you recognize arthritis? Well if you feel pain and stiffness in your body or have trouble moving around, you might have arthritis. Most kinds of arthritis cause pain and swelling in your joints. Over time, a swollen joint becomes severely damaged, but the negative impact on your body doesn’t end here, as some kinds of arthritis can also cause problems in your organs, such as your eyes or skin.

The disease is determined partly by genes and partly by factors such as smoking and drinking. Previous studies have shown that smoking increases the risk of the disease.

Forty-six million Americans suffer from some form of arthritis, which is the most common cause of disability in the U.S., limiting the activities of nearly 19 million adults.



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