NEWS - FDA issues reminder on risk for serious fungal infections with TNF-alpha blockers, including Simponi

[Guest guest]

FDA Issues Reminder on Risk for Serious Fungal Infections With

TNF-alpha Blockers, Including Simponi

Published: 29 May 2009

May 29, 2009 -- The US Food and Drug Administration (FDA) has issued a

reminder on the risk for serious fungal infections associated with all

tumor necrosis factor-alpha (TNF-alpha) inhibitors, including

golimumab (Simponi, Centocor Ortho-Biotech Inc). Golimumab is a new

TNF-alpha blocker approved by the FDA for the treatment of adult

patients with moderate to severe rheumatoid arthritis.

The reminder was issued because " histoplasmosis and other invasive

fungal infections are not consistently recognized in patients taking

TNF-á blockers including Cimzia (certolizumab pegol), Enbrel

(etanercept), Humira (adalimumab), and Remicade (infliximab). "

This lack of recognition " has resulted in delays in appropriate

antifungal treatment, sometimes even resulting in death, " according to

an alert sent today by MedWatch, the FDA's safety information and

adverse event reporting program.

As previously reported by Medscape Medical News , the FDA ordered

makers of TNF-alpha inhibitors to strengthen warnings regarding the

risk for histoplasmosis and other invasive fungal infections on

September 4, 2008.

The FDA emphasized the importance of reporting all adverse events

potentially associated with golimumab and other TNF-alpha inhibitors

so that drugs' prescribing information can be updated accordingly as

more experience with the drugs is gathered.

Adverse events potentially associated with golimumab may be reported

to Centocor at 1-800-457-6399. Adverse events may also be reported to

the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088,

by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by

mail to 5600 Fishers Lane, Rockville, land 20852-9787.

http://www.medscape.com/viewarticle/703593

Not an MD