FDA-Approved Arthritis Drugs Could Lead to Fatal Fungal Infections

October 22, 2008

September 05, 2008 3:09 PM

by Cara McDonough

The four arthritis drugs are the latest approved medications to necessitate

stronger warnings from the FDA, after reports of deaths have surfaced.

A Serious Complication

Enbrel, Remicade, Humira and Cimzia are drugs that provide relief from the

swollen and painful joints associated with rheumatoid arthritis. The problem,

however, is that the drugs work by suppressing the immune system to keep it from

attacking the body, which means they make people more susceptible to various

infections, the Associated Press reports.

Dr. Siegel of the U.S. Food and Drug Administration said the agency

recently became concerned when 240 cases of a fungal infection called

histoplasmosis surfaced in people taking the arthritis drugs, resulting in 45

deaths.

The news comes on the heels of the announcement of an FDA investigation of a

possible cancer link with the FDA-approved cholesterol-lowering drug Vytorin.

Histoplasmosis, which attacks the respiratory system but can spread to other

organs leading to fatal consequences, has symptoms like the flu. So not only is

it difficult to diagnose, but may be caught too late.

The FDA has issued a warning about histoplasmosis to healthcare professionals on

its Web site, noting that the infection is not “consistently recognized” in

patients taking the drugs.

Siegal said that the FDA warning means the risk of the fungal infection will be

listed in a “black box,” which is “the strongest warning information in a drug's

prescribing literature.”

Patients who take any of the four arthritis drugs and exhibit any signs of

histoplasmosis, including persistent fever, cough, shortness of breath or

fatigue, are urged to call their doctor.

To read more:

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