Acetaminophen / chlorpheniramine / dextromethorphan / guaifenesin / phenylephrine Pregnancy and Breastfeeding Warnings

Brand names: Tylenol Cold and Flu Severe Day & Night

Acetaminophen / chlorpheniramine / dextromethorphan / guaifenesin / phenylephrine Pregnancy Warnings

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

Acetaminophen: Routinely used during all stages of pregnancy, it appears safe for short-term use. This drug crosses the placenta.

Chlorpheniramine: A monitoring study of 50, 282 mother/child pairs (1070 first trimester exposures, 3931 any time pregnancy exposures) did not suggest a link to categories of major or minor malformations, however possible individual associated malformations were found (7 cases polydactyly in 272 blacks, 13 gastrointestinal defect cases, 7 cases of eye and ear defects, 22 inguinal hernias, 8 hydrocephaly cases, 16 congenital hip malformations, and 6 cases of female genitalia malformations). A 1971 study in which chlorpheniramine was the sixth most used antihistamine found fewer malformations in infants exposed to antihistamines in the first trimester. Antihistamine exposure during the last 2 weeks of pregnancy may be associated with retrolental fibroplasia in premature infants.

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

Guaifenesin: Animal studies are not available. A monitoring study including 197 mother-child pairs that had first trimester guaifenesin exposure showed an increase in inguinal hernias; 1336 any time pregnancy exposures showed no association with 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).

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:
-Acetaminophen is commonly used during pregnancy and has been assumed safe; recent data questions the safety, especially with routine use or varying genetics.
-Routine use of acetaminophen during pregnancy is not advised.
-Chlorpheniramine is considered by some authorities to have low gestation risk, however a possible association with retrolental fibroplasia has been seen in premature infants.
-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.
-Available data do not indicate developmental toxicity with guaifenesin.
-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.

See references

Acetaminophen / chlorpheniramine / dextromethorphan / guaifenesin / phenylephrine Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Yes (acetaminophen) /Data not available (chlorpheniramine, dextromethorphan, guaifenesin, phenylephrine)
Excreted into animal milk: Data not available (chlorpheniramine, dextromethorphan, guaifenesin, phenylephrine)

Comments:
-The amount of acetaminophen in breast milk is much less than typical infant doses.
-One study calculated that infants receive about 0.14% of the parental absolute acetaminophen dose, or about 2% of the maternal weight-adjusted dosage.
-Occasional small chlorpheniramine doses during breastfeeding may be acceptable, but large doses or prolonged use may have adverse effects on the infant or decrease milk production, particularly in combination with pseudoephedrine or before lactation is established.
-Given dextromethorphan's low molecular weight, excretion into breastmilk is probable.
-Guaifenesin from breast milk is not expected to adversely affect nursing infants at normal parental doses.
-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

Further information

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