Pseudoephedrine (Sudafed ®)
Sympathomimetic agent used as a decongestant (vasoconstrictor). Molecular weight:201.70
CATEGORY: C

A retrospective study by Werler MM,  et al. , found that among mothers of 206 infants with gastroschisis and 126 mothers of infants with small intestinal atresia infants with gastroschisis had an increased risk (odds ratio = 1.8) of having been exposed to pseudoephedrine during gestation. The risk for gastroschisis was increased further (odds ratio = 4.2) among infants who had been exposed to pseudoephedrine combined with acetaminophen. The risk of small intestinal atresia was also increased for any use of pseudoephedrine (odds ratio = 2.0) and for use of pseudoephedrine in combination with acetaminophen (odds ratio = 3.0). The authors of the study cautioned that underlying maternal illness may have confounded the results of this study [1].

Gastroschisis is a congenital defect of the anterior abdominal wall characterized by an opening beside the umbilical cord that allows bowel to protrude. Gastroschisis is thought to arise from disruption of blood flow  to the affected abdominal wall [2]. The defect is uncommon and occurs in the general population with an incidence of  2.4 to 3.2 per 10,000 births in the general population with the highest incidence in women 15-19 years of age ( 26.5 per 10,000 births) [3,4]. The uncommon occurrence of gastroschisis should  be considered when counseling patients or interpreting the literature as to the increased risk for gastroschisis after any particular drug ingestion.

In contrast to the above epidemiological study by Werler MM, et al. three retrospective studies of 1,842 newborns exposed to pseudoephedrine during the first trimester found no increased risk for malformations [5-7]. In addition a prospective study by Schatz et al. also found no increased risk for malformations in 714 infants after exposure to pseudoephedrine at any time during pregnancy[8].

The American College of Obstetricians and Gynecologists (ACOG) and The American College of Allergy, Asthma and Immunology (ACAAI) recommend oral decongestants be avoided during the first trimester "...unless the expected benefit is large and unique" [9].

BREAST FEEDING: Pseudoephedrine is excreted into breast milk and may suppress lactation [10, 11]. The reported milk:plasma ratio (at 3 hours) is 3.9 [10]. At the maximum recommended pseudoephedrine doses, the calculated infant dose delivered via milk is less than 10% of the maternal dose [11]. The American Academy of Pediatrics and the WHO Working Group on Human Lactation consider the occasional use of pseudoephedrine to be compatible with breast feeding [12, 13].