Brompheniramine / dextromethorphan / phenylephrine Pregnancy and Breastfeeding Warnings

Brand names: Alacol DM, Alahist DM (old formulation), BP Allergy DM, BPM DM PHEN, BPM PE DM, Balacall DM, Bromtuss DM, Brotapp PE-DM, BroveX PB DM, BroveX PEB DM, Cold & Cough Childrens, Dimaphen DM, Dimetapp Children's Cold & Cough, Dimetapp Children's Multi-Symptom Cold Relief Dye-Free, Dur-Tann DM, Duravent DPB, EndaCof-DM, LoHist PEB DM, Niva-Hist DM, Presgen B, Rynex DM, TL-Hist DM, Tusdec-DM, Tussi-Pres B, Y-COF DMX

Medically reviewed by Drugs.com. Last updated on Sep 7, 2023.

Brompheniramine / dextromethorphan / phenylephrine Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: B2
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.
-Available human data does not demonstrate major teratogenicity with dextromethorphan.
-Fetuses of mothers with slow dextromethorphan metabolism may be exposed to higher concentrations, but the clinical significance is unknown.
-According to some authorities dextromethorphan is compatible with pregnancy; low birth defect incidences were seen in surveillance studies.
-Phenylephrine is a sympathomimetic used in emergencies to treat hypotension and alleviate eye and ear allergic symptoms.
-Phenylephrine could cause constriction in uterine vessels (that are normally maximally dilated during pregnancy), reducing uterine blood flow, potentially causing fetal hypoxia.
-Phenylephrine may interact with oxytocic or ergot derivatives to cause persistent maternal hypertension; cerebral vessel rupture is possible.
-Sympathomimetic amines are teratogenic in some animal models, but are not suspected to cause human teratogenicity.

Animal studies are not available for the combination product. There are no controlled data in human pregnancy.

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).

Dextromethorphan: Available data does not indicate a major teratogenic risk, and a survey study did not show a relationship with congenital malformations.

Phenylephrine: A monitoring study including 1249 mother-child pairs that had first trimester phenylephrine exposure showed an increase in malformation, with association greater with minor defects than major defects (8 eye and ear defects, 6 syndactyly, 4 preauricular skin tags, and 3 clubfoot cases); 4149 any time pregnancy exposures were associated with 15 congenital dislocation of the hip, 6 umbilical hernia, and 4 other musculoskeletal defects. Placental transfer is likely with phenylephrine's low molecular weight (about 167).

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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.

See references

Brompheniramine / dextromethorphan / phenylephrine Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available (brompheniramine, dextromethorphan, phenylephrine)
Excreted into animal milk: Data not available (brompheniramine, dextromethorphan, phenylephrine)

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.
-Given dextromethorphan's low molecular weight, excretion into breastmilk is probable.
-Phenylephrine oral bioavailability is about 40%, making it unlikely an infant would receive large doses from breast milk.
-Phenylephrine may decrease milk production.

See references