The FDA Has Issued Strong Warnings for Four Arthritis Drugs

On September 4, 2008, the Food and Drug Administration ordered strong warnings on these four arthritis drugs: Enbrel, Remicade, Mumira, and Cimzia, which widely used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease.

The FDA becomes concerned when out of 240 cases reported, a total of 45 people died, about 20 percent, in which the patients took one of the four drugs. These drugs are known as tumor necrosis factor alpha blocker (TNF-alpha blockers), and can cause possible fatal fungal infections, called histoplasmosis.

According to Dr. Jeffrey Siegel of the FDA, these drugs work to relief swollen and painful joints for patients with rheumatoid arthritis, but it is also "a double-edged sword" since the drugs can lower the body's defenses to other kinds of infections.

What Are the Symptoms?

The infection has symptoms of the flu: fever, cough, shortness of breath or fatigue. It is advised that patients should see their physicians immediately if the symptoms persist.

If it is not caught early, the infection can spread to other organs of the body, beyond the respiratory system!

The FDA advised that patients should inform their doctors where they live and what area they recently visited, since most reports found fungus in areas such as Ohio River, and Mississippi River valleys. Patients who have fungal infection may also be advised to stop taking TNF blocker.

Moreover, the FDA urges doctors to use aggressive antifungal drugs in patients who have these symptoms, even before having a laboratory confirmation.

What Are Other Side Effect?

It is early to say, but the FDA is also looking in a potential link between cancer and these four drugs. The FDA received 30 reports of cancers, mostly lymphomas, in people who took these medications when they were 18 or younger. It is an ongoing investigation, and will take some times yet.

What Has Been Done About It?

Although these four drugs: Enbrel, Remicade, Mumira, and Cimzia carried warnings on their labels, the language was vague! The FDA had required manufactures of TNF to change their labeling, and make safety-related clearer! Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products, Center for Drug Evaluation and Research, stated: "Requiring the risks to be highlighted will help health care professionals be more vigilant in watching for these adverse events, and is necessary to ensure that the benefits of these drugs outweigh their risks."

What You Can Do

Tell everybody you know who is currently taking one of these drugs, and watch out for the symptoms. To know more, go to the FDA page in the resource section.