Pseudoephedrine (Sudafed ®)
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"
Sympathomimetic agent used as a decongestant (vasoconstrictor). Molecular weight:201.70
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 .
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 . 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
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.
Pseudoephedrine is excreted into breast milk and may suppress lactation [10,
11]. The reported milk:plasma
ratio (at 3 hours) is 3.9 . At the maximum recommended pseudoephedrine doses, the
calculated infant dose delivered via milk is less than 10% of the maternal dose .
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].
NEONATAL SIDE EFFECTS: Agitation
Over the Counter Cold Medications in Pregnancy
1998 Illinois Teratogen Information Service
1.Werler MM, et al Maternal medication use and risks of gastroschisis
and small intestinal atresia. Am J Epidemiol. 2002;155:26-31
2. Hoyme HE, et al. ;The vascular pathogenesis of gastroschisis: intrauterine interruption of the omphalomesenteric artery.J Pediatr. 1981;98:228-31.MEDLINE
3. Reid KP, et al., The epidemiologic incidence of congenital
gastroschisis in Western Australia. Am J Obstet Gynecol. 2003;189:764-8.
4. Nichols CR, et al., Rising incidence of gastroschisis in teenage pregnancies.
J Matern Fetal Med. 1997;6:225-9.MEDLINE
5. Briggs GG,Freeman RK, Yaffe SJ, Drugs in Pregnancy and Lactation 6th edition, Baltimore, MD:
Williams & Wilkins,2002
6. Aselton P et al. First-trimester drug use and congenital disorders. Obstet Gynecol. 1985;65:451-5.
7. Jick H et al. First-trimester drug use and congenital disorders.JAMA. 1981;246:343-6.
8. Schatz M et al. The safety of asthma and allergy medications during pregnancy. J Allergy Clin Immunol. 1997;100:301-6.MEDLINE
9. The use of newer asthma and
allergy medications during pregnancy. Position Statement. The American
College of Obstetricians and Gynecologists (ACOG) and The American College
of Allergy, Asthma and Immunology (ACAAI). Ann Allergy Asthma Immunol.
10. Findlay JW et al: Pseudoephedrine and triprolidine in plasma and breast
milk of nursing mothers. Br J Clin Pharmacol 18:901-6, 1984.
11. Aljazaf K, Pseudoephedrine: effects on milk production in women and estimation of infant
exposure via breastmilk.Br J Clin Pharmacol. 2003;56:18-24. PMID:
12. The WvHO Working Group, Bennet PN (ed).: Drugs and Human Lactation. Elsevier,
Amsterdam, New York, Oxford, 1988.
13.Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Review.
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