News from the FDA
Dr. Mike brings you the latest news from the U.S. Food and Drug Administration including alerts, new drug approvals, new drug indications, and first time generic drug approvals.
The U.S. Food and Drug Administration (FDA) announced yesterday that the manufacturers of Humira (adalimumab), Cimzia (certolizumab pegol), Enbrel (etanercept), and Remicade (infliximab) must strengthen the existing warnings in the drugs' prescribing information that patients using one of these medications are at increased risk of developing serious fungal infections.
These drugs, known as tumor necrosis factor alpha blockers (TNF-alpha blockers) may be used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn's disease.
The FDA looked at 240 reports of histoplasmosis, an infection caused by the fungus Histoplasma capsulatum, in patients being treated with one of the TNF-blockers. The majority of the patients were from the Ohio River and Mississippi River valleys, where the fungus is commonly found.
According to the FDA, in at least 21 of the cases, histoplasmosis was initially not recognized by health care professionals, and antifungal treatment was delayed. Twelve of those patients died.
The FDA advises patients being treated with TNF blockers to be aware of the risk of infection and to promptly seek medical attention if you have weight loss, persistent fever, sweating, cough, shortness of breath, or fatigue.
More Information from the FDA:
- Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections
- FDA Alert: TNF-Blocker Drugs
Photo © U.S. Food and Drug Administration