According to a fresh story in the Associated Press, the United States Food and Drug Administration has announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the warnings about the risk of developing opportunistic fungal infections. FDA’s statement said the agency “has reviewed 240 reports of histoplasmosis, an infection caused by the fungusHistoplasma capsulatum, in patients being treated with Enbrel, Humira, or Remicade. In at least 21 of the reports, histoplasmosis was initially not recognized by health care professionals, and antifungal treatment was delayed. Twelve of those patients died.”
Another significance of this announcement is that it involves the federal agency’s use of its new authority under the Food and Drug Administration Amendments Act of 2007 to make safety-related changes to prescribing information or labeling. Learn more here.