Ophthalmic (Sympathomimetic)
PREGNANCY RECOMMENDATION: Limited Human Data—No Relevant Animal Data
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
The human pregnancy experience with naphazoline is very limited and animal reproduction studies have not been conducted. In addition, reports describing the amount of drug in the systemic circulation after nasal or ophthalmic use have not been located. However, it is doubtful if appropriate short-term use results in clinically significant systemic concentrations. Thus, the occasional use of naphazoline does not appear to represent a risk to the embryo and/or fetus.
FETAL RISK SUMMARY
Naphazoline is an α-adrenergic agonist that is used as a topical vasoconstrictor to relieve eye redness and as an intranasal spray to treat symptoms of nasal congestion. The drug is available over the counter (1,2).
Reproduction studies in animals have not been conducted (1,2). In addition, no studies evaluating the carcinogenicity or mutagenicity of naphazoline, or its effects on fertility have been located.
It is not known if clinically significant amounts of naphazoline cross the human placenta. The molecular weight (about 210 for the free base) is low enough, but the systemic concentrations after ocular or nasal use should be low.
The Collaborative Perinatal Project monitored 50,282 mother–child pairs, 20 of whom had 1st trimester exposure to naphazoline (3, pp. 346–347). No evidence was found to suggest a relationship between large categories of major or minor malformations or to individual defects. However, an association in the 1st trimester was found between the sympathomimetic class of drugs as a whole and minor malformations (not life-threatening or major cosmetic defects), inguinal hernia, and clubfoot (3, pp. 345–356).
A 1995 report described a case in which naphazoline nasal spray was used repeatedly throughout pregnancy (4). The newborn had cyanosis, hypertension, and ischemia of the foot. The cause of the outcome could not be determined (4).
BREASTFEEDING SUMMARY
No reports describing the use of naphazoline during human lactation have been located. The molecular weight (about 210 for the free base) is low enough for excretion into breast milk, but the expected low systemic concentrations after ocular or nasal use should limit the exposure of the infant. Thus, occasional use of naphazoline during breastfeeding appears to be compatible.
References
1.Product information. Albalon. Allergan, 2003.
2.Product information. Vasocon. CIBA Vision, 2006.
3.Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, 1977.
4.Dageville C, Joly E, Spreux A, Berard E. Toxicite neonatale de la naphazoline administree durant la grossesse. Therapie 1995;50:463–84.