Respiratory Drug (Bronchodilator)
PREGNANCY RECOMMENDATION: Limited Human Data—No Relevant Animal Data
BREASTFEEDING RECOMMENDATION: Limited Human Data—Probably Compatible
PREGNANCY SUMMARY
The absence of animal reproductive data and the very limited human pregnancy experience prevent a complete assessment of the embryo–fetal risk. However, this xanthine derivative is closely related to theophylline, an agent considered compatible in pregnancy. (See also Theophylline.)
FETAL RISK SUMMARY
No published reports describing the use of dyphylline in human pregnancy have been located. In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 97 newborns had been exposed to dyphylline during the 1st trimester (F. Rosa, personal communication, FDA, 1993). Seven (7.2%) major birth defects were observed (four expected), including (observed/expected) cardiovascular defects (3/1), and polydactyly (1/0.3). No anomalies were observed in four other categories of defects (oral clefts, spina bifida, limb reduction defects, and hypospadias) for which specific data were available. Only with cardiovascular defects is there a suggestion of a possible association, but other factors, including the mother’s disease, concurrent drug use, and chance may be involved.
BREASTFEEDING SUMMARY
Dyphylline is excreted into breast milk. In 20 normal lactating women, a single 5 mg/kg IM dose produced an average milk:plasma ratio of 2.08 (1). The milk and serum elimination rates were equivalent. Although the drug accumulates in milk, the American Academy of Pediatrics classifies dyphylline as compatible with breastfeeding (2).
References
1.Jarboe CH, Cook LN, Malesic I, Fleischaker J. Dyphylline elimination kinetics in lactating women: blood to milk transfer. J Clin Pharmacol 1981;21:405–10.
2.Committee on Drugs, American Academy of Pediatrics. The transfer of drugs and other chemicals into human milk. Pediatrics 2001;108:776–89.