FDA Mandates Tougher Standards on Use of Immunosuppressive Drugs
Immunosuppressive drugs are drugs that inhibit or prevent activity of the immune system. They are used to prevent transplant rejection, to treat autoimmune disorders (i.e. rheumatoid arthritis) and to treat other conditions such as asthma.
Federal health authorities have asked the manufacturers of four widely used immunosuppressive drugs to bolster black box warnings on the risk of developing opportunistic fungal infections with the use of these drugs. The four drugs in question are Humira, Cimzia, Enbrel and Remicade.
FDA has asked the black box warnings to be upgraded to warn doctors of the serious side-effects associated with these drugs in particular. “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 can cause flu-like symptoms and has been found in 240 cases of patients taking Embrel, Humira or Remicade – most of whom reside in areas where the fungus is endemic such as the Mississippi River or the Ohio River valleys. Among the 240 patients, 45 died.
FDA warned that these infections must be caught early enough so that treatment is not delayed. In a number of these cases, treatment was delayed and resulted in prolonged hospitalizations and death. This is one area FDA is most concerned about – that awareness be raised to the possibility of fungal infections with the use of these drugs.
These conditions are hard to diagnose and can mimic other conditions. The new message is that fungal infections are under-diagnosed and important to identify. Doctors and patients should be on the look-out for persistent fever, cough, shortness of breath and fatigue. If these symptoms are present, medical help should be sought immediately.
About the author
Kathy Shattler received her Master of Science degree from Michigan State University in E. Lansing Michigan in Human Nutrition. Her twenty-two years of practice includes holding positions as a Lecturer, Chief Clinical Dietitian and Program Manager. Kathy is the Founder of Nutri-Care Consulting and is currently the Nutrition Director of www.CEU4U.COM, an online continuing education management company for Registered Dietitians and Dietetic Technicians.
