Human pregnancy safety for agents used to treat rheumatoid arthritis: adequacy of available information and strategies for developing post-marketing data

Table 4 Disease modifying anti-rheumatic drugs: biologics

Agent	FDA pregnancy category	Adverse effects in human pregnancy	Summary risk assessment
Etanercept	B	No documented increased risk for structural defects	Based on minimal data in human pregnancy, teratogenic risk is undetermined
Infliximab	B
Adalimumab	B
Rituximab	C	No documented increased risk for structural defects based on case report	Based on lack of data in human pregnancy, teratogenic risk is undetermined
Anakinra	B	No available human data	Based on lack of data in human pregnancy, teratogenic risk is undetermined

ISSN: 1478-6362