Anti-inflammatory and immunosuppressive drugs potentially useful in the treatment of pericardial disease

Drug	Pregnancy category*	Transplacental passage	Teratogenicity	Potential fetal-neonatal adverse effects	Long-term effects offspring	Fertility impairment
Aspirin (analgesic dosed) and non-selective NSAIDs	C (1st, 2nd T) D (3rd T)	Yes	Yes	No pattern of birth defects established; can be used safely during 1st and 2nd trimesters. Use in late pregnancy avoided due to concerns over possible effects on ductus arteriosus and renal function; refer to topic discussion. Rare adverse reports (eg, cardiac defects, gastroschisis, low birth weight) might be exposure related (all T).	Unknown (none detected with low dose aspirin)	Case descriptions of follicle rupture inhibition associated with prolonged use. May increase risk of spontaneous abortion if used at time of conception.
Celecoxib	C (1st, 2nd T) D (3rd T)	Expected	Unknown (human) Yes (animal)	Unknown. Interferes with embryonic development in rats and rabbits. Avoid during pregnancy.	Unknown	Unknown. Interferes with fertility in murine models.
Short-acting glucocorticoids (prednisone, prednisolone, methylprednisolone)	D (1st T) C (2nd, 3rd T)	Yes	Yes	May increase risk of orofacial clefting (1st T) and restrict fetal growth (all T). Hypoadrenalism may occur in neonate. Most data are reassuring when used at low to medium doses (ie, 10 to 20 mg orally per day).	None detected	Experience does not suggest impairment.
Colchicine	C	Yes	No (human) Yes (animal)	Colchicine should not be used in pregnancy beyond compelling maternal indication (ie, FMF). It is generally tapered before conception and substituted with aspirin and/or low dose prednisone.	Unknown	Experience in women does not suggest impairment. Rarely associated with infertility in men.
Azathioprine	D	Yes	No (human) Yes (animal)	Reports of hematologic abnormalities, immune impairment, growth restriction, and prematurity may be exposure related. May be rarely used in selected cases in pregnancy.	Unknown	Experience does not suggest impairment. May interfere with efficacy of intrauterine contraceptive devices.
Methotrexate	X	Yes	Yes	Spectrum defects include skull, facial feature, and limb anomalies when exposed during organogenesis (1st T). CNS abnormalities also reported. Growth retardation and mortality may be elevated in 2nd and 3rd T exposure. Use in pregnancy is absolutely contraindicated.	Developmental delay and intellectual impairment reported	Oligospermia in men and amenorrhea in women when used for cancer chemotherapy in combination with other agents.
Cyclophosphamide	D	Yes	Yes	Skeletal, palate, ocular, and limb defects associated with exposure during 1st T. 2nd and 3rd T exposure associated with smaller risk of malformations but hematologic abnormalities and growth restriction reported may be exposure related. Use in pregnancy is absolutely contraindicated.	Unknown	Gonadal toxicity established in dosage regimens for cancer chemotherapy.
Cyclosporine	C	Yes	No	Experience, based on limited case reports, does not establish an increased risk of birth defects. Reports of growth restriction, miscarriage, and preterm delivery may be exposure related. May be rarely used in selected cases during pregnancy.	Unknown	Experience does not suggest impairment.
Intravenous immunoglobulins (IVIG)	C	Yes	No	Experience does not suggest an increased risk of congenital anomalies or other adverse embryonic effects. May be rarely used in selected cases in pregnancy.	Unknown	Unknown

T: trimester of pregnancy; NSAID: nonsteroidal anti-inflammatory drug; FMF: familial Mediterranean fever; CNS: central nervous system.
* Description of the US Food & Drug Administration (FDA) pregnancy risk categories is provided in a separate table available in UpToDate. In 2015, US FDA began overseeing the phase-out of pregnancy risk categories (A, B, C, D, and X ) from prescription drug labeling and began requiring information from available human and animal studies of (1) known or potential maternal or fetal adverse reactions, and (2) dose adjustments needed during pregnancy and the postpartum period. Additional information is available at the US FDA website: Pregnancy and Lactation Labeling Final Rule.

Data from:

United States FDA approved product information. http://dailymed.nlm.nih.gov/dailymed/index.cfm (Accessed November 25, 2014).

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Anti-inflammatory and immunosuppressive drugs potentially useful in the treatment of pericardial disease