Alerts
Anti-Tumor Necrosis Factor (TNF) Agents (adalimumab [Humira], certolizumab pegol [Cimzia], etanercept [Enbrel], infliximab [Remicade], golimumab [Simponi]) -Ongoing Safety Review of Malignancy Risk - UPDATE
November 4, 2009
FDA is requiring manufacturers of anti-tumor necrosis factor (TNF) agents to conduct additional safety surveillance related to the risk of pediatric malignancy associated with these agents. Increased surveillance and reporting requirements will allow FDA to gain a better understanding of the risk of malignancy associated with anti-TNF agents in young adults and pediatric patients. FDA is also encouraging healthcare providers to continue to report malignancies occurring in patients treated with anti-TNF agents. Reports should include de-identified patient demographic information, risk factors for malignancy, concurrent or past immunosuppressant exposure, anti-TNF agent indication, dose, and duration, and date of malignancy diagnosis and outcome.
In September 2009, FDA completed a safety analysis of the anti TNF agents (adalimumab [Humira], certolizumab pegol [Cimzia], etanercept [Enbrel], infliximab [Remicade], golimumab [Simponi]). These agents can increase the risk of leukemia, lymphoma, and other cancers in children and adolescents. Thirty cases of cancer in this population were reported between 1998 and April 2008. Patients affected were under 18 years of age and began taking anti-TNF agents in addition to other immunosuppressants, such as methotrexate or azathioprine, for Crohn's disease, juvenile idiopathic arthritis, or other diseases. About 50% of the cancers were lymphomas. Other malignancies included melanoma, leukemia, and solid organ cancers. Warnings have been added to the boxed warnings sections of the prescribing information as well as the required Medication Guides for these agents.
The new warnings will be added to the boxed warnings sections of the prescribing information as well as the required Medication Guides for these agents.
The FDA requires the distribution of Medication Guides for drugs determined to be a serious and significant public health concern. With the exception of the ESAs, this requirement applies primarily to medications dispensed in the outpatient setting (refer to Code of Federal Regulations 21CFR208.1) for patient self-administration. When other prescription medications are administered to patients by healthcare professionals (ie, in the hospital, in infusion centers, dialysis centers, clinics, or offices), distributing a Medication Guide is not required, although it may be appropriate to educate patients about the potential hazards of prescription medications, at the clinician’s discretion.
The complete list of drugs that require a Medication Guide as part of the FDA-regulated product labeling is available online at: http://www.fda.gov/cder/Offices/ODS/labeling.htm.
More information is available at the following links:
- Drug Safety Communication November 3, 2011:
http://www.fda.gov/Drugs/DrugSafety/ucm278267.htm - FDA Questions and Answers:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm180694.htm - MedWatch Alert August 7, 2009:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm174449.htm - Information for Healthcare Professionals:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm174474.htm - MedWatch Alert June 4, 2008:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm105999.htm - Early Communication About Ongoing Safety Review:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm070725.htm
Updated
November 4, 2011; September 2, 2009; August 7, 2009; June 4, 2008; University of Uta, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
