FDA Demands Tougher Warnings on Immunosuppressive Drugs

Sept. 5 -- THURSDAY, Sept. 4 (HealthDay News) -- Federal health authorities have asked the manufacturers of four widely used immunosuppressive drugs to bolster safety warnings on the risk of developing opportunistic fungal infections.

The drugs, Humira, Cimzia, Enbrel and Remicade, belong to a class of medications known as tumor necrosis factor alpha blockers (TNF-alpha blockers), which suppress the immune system and are approved to treat several conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis and Crohn's disease.

All four drugs already carry black-box warnings related to different safety issues, including fungal infections.

"FDA has asked the manufacturers of these four drug products to highlight existing warnings of fungal infections," Dr. Jeffrey Siegel, clinical team leader in the division of anesthesia, analgesia and rheumatology products at the FDA's Center for Drug Evaluation and Research, said at a Thursday news conference. "The box warning, which is the most serious warning in the labeling, must be upgraded to strongly warn doctors to consider the occurrence of histoplasmosis and other fungal infections."

Histoplasmosis is caused by the fungus Histoplasma capsulatum and can cause flu-like symptoms. The FDA reviewed 240 reports of histoplasmosis in patients taking Enbrel, Humira or Remicade, most of whom reside in the Ohio River and Mississippi River valleys, where the fungus is endemic.

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Twenty-one of these patients had delayed diagnoses and therefore delayed treatment. Of these, 12 died. Overall, among the 240 patients reviewed, 45 died.

"These infections need to be identified early enough so that treatment is not delayed," Siegel said. "In a number of cases, treatment was delayed and resulted in prolonged hospitalization and death."

Authorities also looked at one reported case of histoplasmosis in a patient taking Cimzia. There have also been reports of other fungal infections, notably coccidioidomycosis and blastomycosis, some fatal, in patients taking these drugs.