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Black Box Warning Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. ENBREL should be discontinued if a patient develops a serious infection or sepsis.
Reported infections include: |
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Black Box Warning Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. ENBREL should be discontinued if a patient develops a serious infection or sepsis.
Reported infections include: Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
Bacterial, viral and other infections due to opportunistic pathogens. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ENBREL, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
MALIGNANCY |
On Dec. 17, 2009, the Food and Drug Administration (FDA) announced that it is now requiring updates to safety labeling for the family of drugs known as tumor necrosis factor blockers (TNF blockers). These drugs, which suppress the immune system, are most often prescribed for severe rheumatoid arthritis.
This family of drugs already had a black box warning about the possibility of developing serious infections including tuberculosis.
The black box warning for these drugs was revised upon the FDA’s completion of an ongoing safety review conducted between June 2008 and August 2009. As a result of this review, the revised warning now reflects that lymphoma (tumor of lymph tissue) and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers.
It is our view that these drugs should be used in pediatric patients only if the benefits are thought to outweigh the risks of malignancy.
See the Table on this page for a list of the five TNF blockers currently approved for sale in the U.S.
A black box is the strongest type of safety warning that the FDA can require in a drug’s professional product label (sometimes called a package insert). These warnings are reserved for products that can cause serious harm or death to patients.
The full text of the etanercept (ENBREL) black box warning appears below. The text is exactly the same for the other four drugs in this family.
Medication Guide
TNF blockers are among a growing list of drugs that are required to be dispensed with an FDA-approved Medication Guide written specifically for consumers in non-technical language. Medication Guides may be required for drugs that present serious public health concerns.
What You Can Do
Parents of children who are using one of these drugs should consult the prescriber as soon as possible.
If you are using one of these products, contact your health care provider if you suspect you are developing an infection.
Read the Medication Guide each time you receive a prescription for a TNF blocker, as the information has been updated. The Medication Guides for these five and other drugs can be obtained by asking a pharmacist who stocks one of these drugs.
Table. Tumor Necrosis Factor Blocking Drugs Available in the U.S.
|
Generic Name |
BRAND NAME |
|---|---|
|
certolizumab |
CIMZIA |
|
etanercept |
ENBREL** |
|
adalimumab |
HUMIRA** |
|
infliximab |
REMICADE** |
|
golimumab |
SIMPONI |
** Limited Use in "Worst Pills, Best Pills"
