Manufacturers must strengthen warnings for four arthritis drugs: Cases of serious fungal infections being missed by health care providers
September 05, 2008
Knowing about the possible dangers of prescription drugs is important to the Baby Boomer Generation.
Manufacturers of four drugs used to treat arthritis and other serious illnesses must strengthen the existing warnings on the risk of developing fungal infections in guides to prescribing medications developed for health care providers, the U.S. Food and Drug Administration announced recently.
Some patients with invasive fungal infections who were taking the drugs have died, according to the FDA.
The drugs
The drugs are Humira, Cimzia, Enbrel, and Remicade. Known as tumor necrosis factor alpha blockers (TNF-alpha blockers), they work by suppressing the immune system to keep it from attacking the body. The four drugs are approved to treat rheumatoid arthritis, juvenile arthritis, certain types of psoriasis, Crohn's disease, and other immune system disorders.
Since the initial approval of the four TNF blockers, the prescribing information for these drugs has included information about the risk of serious infections, including fungal infections. However, based on reports reviewed by the FDA, health care providers aren’t consistently recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment.
Symptoms of fungal infections
Patients taking TNF blockers should be aware that they’re more susceptible to serious fungal infections, the FDA said in its statement. Those who develop a persistent fever, cough, shortness of breath, and fatigue should promptly seek medical attention.
To assist in the diagnosis, those being treated with TNF blockers should tell their health care providers where they live and what areas they have recently visited. Patients who develop a fungal infection may be advised to stop the TNF blocker until they recover, according to the FDA.
Reports of deaths
The FDA reviewed 240 reports of histoplasmosis, an infection caused by the fungus Histoplasma capsulatum, in patients being treated with Enbrel, Humira, or Remicade. The majority of the reports involved people in the Ohio River and Mississippi River valleys where the fungus is commonly found. In at least 21 of the reports, histoplasmosis wasn’t initially recognized by health care professionals, and antifungal treatment was delayed, the FDA reports. Twelve of those patients died.
The FDA reviewed one reported case of histoplasmosis in a patient taking Cimzia. The agency also has received reports of cases of two other types of fungal infection – coccidioidomycosis and blastomycosis – that have resulted in deaths in patients treated with TNF blockers.
The labeling process
TNF blocker manufacturers are required to submit safety labeling changes, including strengthened warnings and revisions to the medication guides to the FDA within 30 days or to provide a reason why they don’t believe labeling changes are necessary.
If they don’t submit new language, or if the FDA disagrees with the new language the company proposes, the Food and Drug Administration Amendments Act of 2007 provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information.
The manufacturers for the four drugs also will be required to educate prescribers about the risks.
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