Simponi (golimumab)
May 28, 2009
Audience: Rheumatological healthcare professionals
Centocor Ortho Biotech and FDA reminded healthcare professionals of the risk of serious fungal infections associated with TNF-α blockers, including Simponi [golimumab]. FDA has reported that histoplasmosis and other invasive fungal infections are not consistently recognized in patients taking other TNF-α blockers including Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). This has resulted in delays in appropriate antifungal treatment, sometimes even resulting in death. It is important that all adverse events potentially associated with Simponi be reported so that the adverse event profile reported in the prescribing information can be updated appropriately as post-approval experience is gathered. Centocor encourages reporting adverse events to Centocor at 1-800-457-6399 or to the FDA MedWatch program at 1-800-332-1088.More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
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