FDA requesting increased fungal infection warnings on TNF blocker drugs
The Food and Drug Administration (FDA) is advising manufacturers of drugs known as tumor necrosis factor-alpha (TNF-alpha) blockers (marketed as Remicade®, Enbrel®, Humira® and Cimzia®) to strengthen existing warning labels to include the risks of histoplasmosis and other invasive fungal infections.
Labels currently warn against the risk for developing serious infections, including fungal infections, but not histoplasmosis specifically. According to an FDA release, "Based on reports reviewed by the FDA, health care professionals are not consistently recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment."
The FDA reviewed 240 reports of histoplasmosis in patients treated with a TNF blocker. Of those reported cases, 12 patients died.
"Warning labels bring attention to the drugs' possible adverse side effects," said National Psoriasis Foundation Director of Research Bruce Bebo Jr., Ph.D. "Including additional safety precautions on the warning labels will help ensure that heath care professional treat symptoms appropriately."
The National Psoriasis Foundation encourages patients using a TNF blocker to discuss the benefits and risks with their health care provider.
"It's important that physicians caring for patients using TNF blockers, especially those living near the Ohio River and Mississippi River valleys where histoplasmosis is endemic, recognize the additional risks to their patients," says Mark Lebwohl, M.D., professor and chairman of dermatology at the Mt. Sinai School of Medicine and chair of the National Psoriasis Foundation Medical Board.
Read the full FDA alert at http://www.fda.gov/cder/drug/InfoSheets/HCP/TNF_blockersHCP.htm
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