Deaths Heighten Arthritis Drugs Warning
Enbrel, Humira, Remicade, and Cimzia to Get Stronger Warning About Fungal Infections
Stronger Warning for Fungal Infections continued...
He says the strengthened warnings will also encourage doctors to identify at-risk patients (including people who live in the Ohio and Mississippi River valleys, where histoplasmosis is more common), and to consider starting certain patients on antifungal therapy if it's likely that they have histoplasmosis -- even if that hasn't been confirmed by lab tests.
Antifungal treatment is effective but can be "highly toxic," says Siegel, warning that the decision to start such antifungal treatment is "not to be taken lightly."
Histoplasmosis can be "particularly difficult to diagnose," says Siegel, adding that histoplasmosis tests sometimes miss histoplasmosis.
Drug Companies Respond
Seigel says all drug companies that make TNF blockers are cooperating with the FDA.
WebMD contacted the makers of all four TNF blockers for their comments. Humira is made by the drug company Abbott. Cimzia is made by the drug company UCB. Remicade is made by the drug company Centocor. Enbrel is marketed by the drug companies Amgen and Wyeth. .
Laureen Cassidy, a spokeswoman for Abbott, tells WebMD that Abbott "will comply with the FDA's request." Cassidy notes that Humira's black-box warning already mentions fungal infections and refers to a bolded warning elsewhere in Humira's label about histoplasmosis, and that the infection is rare but can go unrecognized.
Sonia Fiorenza, director of corporate communications for Amgen, told WebMD via email that Amgen will work with the FDA to "finalize and communicate revised product labeling for Enbrel to both physicians and patients."
Bert Kelly, spokesman for UCB, says his company will "certainly" work with the FDA. "We had very strong safety language; if the FDA thinks there needs to be some stronger language, we'll work to get that done," Kelly tells WebMD.
Centocor did not provide comments to WebMD in time for publication.