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. 2019 May 31;6(6):73. doi: 10.3390/children6060073

Table 6.

FDA Black Box warning and contraindications.

Natalizumab Progressive Multifocal Encephalopathy (PML)
Contraindicated if history of PML.
Teriflunomide Contraindicated in patients with pre-existing acute or chronic liver disease
contraindicated in women of childbearing potential
Hepatotoxicity and risk of teratogenicity
Alemtuzumab Risks of serious and sometimes fatal autoimmune conditions, infusion reactions, and various malignancies.
It is contraindicated in human immunodeficiency virus due to CD4 + lymphocyte count reductions
Daclizumab Daclizumab is contraindicated in Hepatitis B and C or liver impairment
Removed from US market due to Autoimmune encephalitis
Risk of severe liver injury and immune-mediated disorders, such as skin reactions, lymphadenopathy, and noninfectious colitis
Fingolimod Fingolimod is contraindicated: if there is a cardiac event or vascular event like a stroke or TIA, irregular heart rate in the past 6 months and or medication that slows the QTc
Siponimod Patients with a CYP2C9*3/*3 genotype (4)
In the last 6 months, experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III/IV heart failure (4)
Presence of Mobitz type II second-degree, third-degree AV block, or sick sinus syndrome, unless patient has a functioning pacemaker (4)