Posted 9/5/2008 6:11 AM (GMT -6)
FDA requests stronger warnings for rheumatoid arthritis drugs.
The Wall Street Journal (9/5, B5, Favole, Wang) reports that on Thursday, the Food and Drug Administration (FDA) "demanded beefed-up warnings on the labels of four big-selling drugs for arthritis and Crohn's disease to alert patients to the risk of serious fungal infections." The stronger warning labels will apply to "Johnson & Johnson's Remicade (infliximab), Abbott Laboratories's Humira (adalimumab), Enbrel (etanercept) from Amgen, Inc. and Wyeth, and UCB SA's Cimzia (certolizumab). The companies have been cooperating fully with the FDA, said Jeffrey Siegel, M.D., leader of the FDA division that regulates arthritis products." These drugs belong to "a class of treatments known as TNF [tumor necrosis factor] blockers." The agency "said it reviewed 240 reports of histoplasmosis, a particularly invasive respiratory disease with symptoms similar to the flu, in patients being treated with Enbrel, Humira, or Remicade. The FDA found one case of the disease in a patient taking Cimzia."
The AP (9/5, Alonso-Zaldivar) provides further details on histoplasmosis, adding that it "mimics the flu, [and] is prevalent in much of the middle part of the country. It can have particularly grave consequences if it isn't caught early, and spreads beyond the respiratory system to other organs of the body." To date, "a total of 45" or about 20 percent, of the 240 cases of histoplasmosis reported to the FDA have died.
As a result of these fungal infections, "the FDA ordered the companies to strengthen existing cautions in a black box in the drugs' prescribing information," Bloomberg (9/5, Larkin) notes. The drugmakers "also must educate doctors about the risks and the symptoms of fungal infections."
HealthDay (9/4, Gardner) pointed out that "the FDA is already in the middle of a safety review of TNF blockers, including an investigation into whether or not the drugs are linked with the development of cancer, particularly lymphoma, in children and young adults." Notably, "all the drug labels already include information about possible fungal infections, but authorities expressed concern that the issue wasn't highlighted appropriately." Dr. Siegel also stated that while the warning about "the possibility of serious infectious" has always been on the labels, "what's new is that" the FDA "became aware that some physicians may not be considering the possibility of fungal infections early enough," because the fungal infections "can mimic other conditions."
AHN (9/4, Sharma), WebMD (9/4, Hitti), the UPI (9/5), MedPage Today (9/4, Neale), Medscape (9/4, Waknine), the Wall Street Journal's (9/4, Goldstein) Health Blog, and USA Today's (9/4, Winter) On Deadline blog also covered the story.