FDA increases drug warnings for TNF blockers

WASHINGTON A risk of fungal infection has prompted the Food and Drug Administration to call on four drug makers to strengthen warnings on some of their products.

Johnson & Johnson’s Remicade (infliximab), Abbott Laboratories’ Humira (adalimumab), Amgen’s and Wyeth’s Enbrel (etanercept) and UCB’s Cimzia (certolizumab pegol) are the drugs affected after the FDA reviewed 240 reports of the respiratory fungal disease histoplasmosis in patients using the drugs. Of the 240 patients, 45 died from the disease, whose symptoms resemble those of the flu.

The drugs belong to a class of drugs that block tumor necrosis factor, which normally helps the body fight cancer but is sometimes overproduced, leading to diseases such as arthritis and Crohn’s disease.

“Amgen and Wyeth are committed to the safety of patients,” the companies said in a jointly released statement Friday. “Both companies maintain ongoing safety surveillance programs worldwide to analyze and evaluate safety reports from controlled and open-label clinical trials and patient registries, as well as reports received from health care professionals and patients. Both companies work with regulatory agencies to update the label periodically as appropriate based on emerging information.”

Amgen, they stated, will work with the FDA to finalize and communicate revised product labeling for Enbrel to both physicians and patients.