FDA Issues Stern Warnings Over TNF Blocker Infections

After dozens of patients suffered from several fungal infections and lost their lives, the US health regulators stirred into action this Thursday and ordered strong warnings for prescription drugs used for the treatment of rheumatoid arthritis, Crohn’s disease and other conditions.

The US Food and Drug Administration said that the TNF blocker medications include Johnson and Johnson’s Remicade, Abbott Laboratories Inc's Humira, UCB SA's Cimzia and Amgen Inc and Wyeth's Enbrel.

According to Jeffrey Siegel, a clinical team leader of the FDA’s Division of Anesthesiadefine, Analgesia and Rheumatology Products, the latest warnings “must be upgraded to strongly warn doctors to consider" the possibility of fungal infections in patients who are seriously ill or who are not responding to current antibiotics.

The cause behind the occurrence of rheumatoid arthritis, Crohn’s disease and other conditions targeted by the four medications is basically inflammation. These drugs suppress the immune systemdefine to combat such occurrences. But this process can make the patients more susceptible to other complications.

The agency officials reviewed 240 reported infections caused by the fungus Histoplasma capsulatum in patients who were taking Enbrel, Humira or Remicade. As per FDA, in 21 of these 240 cases, the infection could not be initially detected in time by the doctors. Subsequently 12 of the 21 patients died.

Histoplasma is basically a disease which attacks the respiratory system. The main problem is that it is difficult to diagnose because it has symptoms similar to those of flu. These include fever and cough.

There have also been reports of other fungal infections like coccidioidomycosis and blastomycosis in patients taking the tumor necrosis factor or TNF alpha blockers.

Though strong “black box” warnings about the grave risk of fungal and other infections have already been put up on some of the drug’s labels, the FDA wants these to be consistent for all products.

Seigal said that part of the problem is that doctors and patients are unable to detect the infection in time which results in delay in providing treatment.

According to FDA, the areas in the middle part of the United States near the Ohio River and Mississippi river valleys are where most of the infected patients reside.

The FDA is also in the process of determining if the TNF blocker drugs are in any way related to an increased risk of cancerdefine in children and teenagers. The review might be submitted in 6 months.