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FDA Orders Stronger Warnings On Arthritis Drugs

Posted by Chrissie Cole
Friday, September 05, 2008 12:05 AM EST
Category: Major Medical
Tags: FDA & Prescription Drugs, Arthritis, Rheumatoid Arthritis, Enbrel, Remicade, Humira, Cimzia, Abbott Laboratories, Wyeth, Schering-Plough Inc, Fungal Infection, TNF blockers

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IMAGE SOURCE: © iStockPhoto / Arthritis Chart / author: dlerick

The U.S. Food and Drug Administration (FDA) has ordered the manufacturers of Cimzia, Enbrel, Humira and Remicade to strengthen existing warnings on the drugs’ prescribing information and Medication Guides, on the risk of developing a possibly fatal fungal infection.

Humira, Cimzia, Remicade and Enbrel are known as tumor necrosis factor (TNF) blockers widely used to treat rheumatoid arthritis and other serious illnesses including psoriatic arthritis and Crohn’s Disease.

TNF blockers work to suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and autoimmune related diseases.

The prescribing information on TNF blockers has included information about the risk of serious infection, including fungal infections since approval. However, upon reviewing reports the agency found that doctors are failing to consistently recognize cases of histoplasmosis and other serious fungal infections over an extended period.

The agency began investigating after a woman taking Cimzia later died of histoplasmosis, said Dr. Jeffrey Siegel of the FDA. Closer inspection of the case by agency doctors found that the woman had been sick with the fungal infection for an extended period.

The agency has received 240 reports in which patients taking one of the four drugs developed this infection, of which 45 died.

The infection mimics flu-like symptoms. The majority of cases involved people in the Ohio River and Mississippi River valleys. If not caught early on, the infection can spread from the respiratory system to other organs and become fatal.

Patients currently taking TNF blockers should be aware that they are at risk of developing a serious fungal infection. Those who develop a persistent cough, fever, problems breathing or fatigue – all of which can be signs of a fungal infection, are advised to seek medical attention immediately.

Manufacturers of TNF blockers must submit safety labeling changes, including stronger warnings and revisions to the Medications Guide, to the FDA within 30 days or provide a reason why they feel the labeling changes are not necessary. #


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