Table 7.

Safety considerations for the use of bDMARDs reported by the Food and Drug Administration.

Drug Class	Safety Warnings from FDA	Contraindications
Infliximab [14]	Increases mortality in moderate or severe heart failure (NYHA class III/IV) Increased cases of tuberculosis and other serious infections including histoplasmosis, listeriosis and pneumocytosis Increased risk of acute liver failure, jaundice, hepatitis and cholestasis Increased risk of malignancies Hypersensitivity to the active substance	Moderate-to-severe heart failure Hypersensitivity to Infliximab or inactive components or to any murine proteins
Etanercept [13]	Nervous system disorders including demyelinating disorders such as multiple sclerosis, myelitis and optic neuritis Active infections Hypersensitivity to the active substance	Sepsis
Adalimumab [15]	Serious infections when administered in combination with Anakinra Hypersensitivity reactions Hematologic events including pancytopenia and aplastic anaemia	None
Certolizumab pegol [16]	Do not start during serious infection, e.g., invasive fungal infection Monitor for worsening or new onset heart failure or demyelinating disease Monitor for cytopenia and lupus-like syndrome Hypersensitivity to the active substance	None
Golimumab [17]	Do not start during serious infection and malignancies Monitor for worsening or new onset heart failure or demyelinating disease Hepatitis B reactivation Hypersensitivity to the active substance	None
Canakinumab [18]	Activation of infection Hypersensitivity to the active substance	Combination with TNF inhibitors Hypersensitivity to Canakinumab or any of the inactive ingredients
Anakinra [19]	Serious infections Higher rate of infections and neutropenia is seen when used in combination with etanercept	Use of Anakinra with TNF-blocking agents should be given with extreme caution
Tocilizumab [20]	Serious infections leading to hospitalization or death, including tuberculosis, bacterial, invasive fungal, viral and other opportunistic infections Gastrointestinal perforation Monitor potential consequences of treatment-related changes in neutrophils, platelets, lipids and liver function tests Hypersensitivity	Hypersensitivity to Tocilizumab
Sarilumab [21]	Serious infections Monitor potential consequences of treatment-related changes in neutrophils, platelets, lipids and liver function tests Gastrointestinal perforation	Hypersensitivity to sarilumab or any of the inactive ingredients Active infections
Ustekizumab [22]	Serious infections Tuberculosis Malignancies Reversible posterior leukoencephalopathy syndrome	Hypersensitivity to Ustekizumab or any of the inactive ingredients Active infections
Guselkumab [23]	Evaluate infections and tuberculosis	None
Tildrakizumab [24]	Evaluate infections and tuberculosis	Serious hypersensitivity reaction to tildrakizumab or to any of the excipients
Secukinumab [25]	Evaluate oral candidiasis and malignancy	Serious hypersensitivity reaction to secukinumab or to any of the excipients
Brodalumab [26]	Depression, suicide ideation and behaviour disorders Serious infections, e.g., tuberculosis	Crohn’s disease
Ixekizumab [27]	Evaluate infections and tuberculosis	Serious hypersensitivity reaction to ixekizumab or to any of the excipients Inflammatory bowel disease: Crohn’s disease and ulcerative colitis including exacerbations

NYHA: New York Heart Association scale.