Brompheniramine: A monitoring study including 65 mother-child pairs that had first trimester brompheniramine exposure showed a statistically significant (10 incidences) association with congenital defections (this relationship was not seen with other antihistamines); 412 any time pregnancy exposures were not associated with any malformations. Use of antihistamines during the last 2 weeks of pregnancy was associated with retrolental fibroplasia in premature infants (22% in exposed infants, 11% in non-exposed controls).

Pseudoephedrine: A monitoring study of 50, 282 mother/child pairs (3082 first trimester sympathomimetic drug exposures, 9719 any time pregnancy exposures) suggested a link to categories of minor malformations (non-life-threatening, no major cosmetic defects) including inguinal hernia and clubfoot. Pseudoephedrine may be associated with gastroschisis, but this may also be caused by maternal health factors. First trimester oral decongestant exposure or maternal smoking may increase the risk of gastroschisis, small intestinal atresia (SIA), and hemifacial microsomia.


US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-Some authorities consider antihistamines to be low risk, but near-birth exposure in preterm infants may increase the risk of retrolental fibroplasia.
-Pseudoephedrine use during the first trimester may be associated with gastroschisis and small intestinal atresia (SIA); data is limited and unconfirmed, risk appears to be low (only identifiable by case-control studies), and may only occur in combination products, but avoidance during the first trimester is nonetheless recommended.

See references

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Yes (pseudoephedrine)/ Data not available (brompheniramine)
Excreted into animal milk: Data not available (brompheniramine)

Comments:
-According to some authorities adverse events are not expected with occasional small doses of brompheniramine; high dose or prolonged use may cause adverse effects (including irritability, colicky symptoms, drowsiness) in the infant or decreased milk supply, particularly in combination with a sympathomimetic amine (e.g. pseudoephedrine) or before lactation is well established.
-Although non-sedating antihistamines are preferred, dosing brompheniramine after the last feeding of the day may minimize any potential adverse effects on the infant.
-The small amounts of pseudoephedrine (about 4.3 to 5.5% of maternal dose) may cause occasional irritability.
-A single pseudoephedrine dose acutely decreases milk production (average 24%); repeated use interferes with lactation.
-Do not use pseudoephedrine in patients with insufficient milk production or in those just establishing lactation.

See references