Cromolyn Sodium

Name: CROMOLYN SODIUM
Class: Respiratory Anti-inflammatory (Inhaled)
Risk Factor: BM

Fetal Risk Summary

Cromolyn sodium is an inhaled anti-inflammatory agent used for the prevention of bronchial asthma. The drug is generally considered safe for use during pregnancy (1,2,3,4,5 and 6). Although small amounts are absorbed systemically from the lungs, it is not known whether the drug crosses the placenta to the fetus (6).
Reproductive studies using SC doses of cromolyn in mice, rats, and both SC and IV in rabbits have not revealed teratogenicity (7,8). In one source, the doses used in the three animal species were 27, 16, and 98 times the maximum recommended human dose, respectively, on a mg/m2 basis (8). Increased resorptions and decreased fetal weight were observed only with high parenteral doses that were associated with maternal toxicity (8).
A 1984 study, cited by Shepard, reported over 300 pregnancies in which cromolyn was used in combination with other drugs, most often with isoproterenol, without a link with congenital defects (9).
Congenital malformations were noted in four (1.35%) newborns in a 1982 study of 296 women treated throughout gestation with cromolyn sodium (10). This incidence is less than the expected rate of 2%–3% in a nonexposed population. The defects observed were patent ductus arteriosus, clubfoot, nonfused septum, and harelip alone. The author concluded that there was no association between the defects and cromolyn sodium (10).
As of 1983, the manufacturer had reports of 185 women treated during all or parts of pregnancy, but the small number probably reflects underreporting of the actual usage (personal communication, Fisons Corporation, 1983). From these cases, 10 infants had been born with congenital defects, at least 3 of which appeared to be genetic in origin. Multiple drug exposure was common. In none of the 10 cases was there evidence to link the defects with cromolyn sodium.
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 191 newborns had been exposed to cromolyn during the 1st trimester (F. Rosa, personal communication, FDA, 1993). Seven (3.7%) major birth defects were observed (eight expected). Specific data were available for six defect categories, including (observed/expected) 1/2 cardiovascular defects, 1/0.5 oral clefts, 0/0 spina bifida, 1/0.5 polydactyly, 0/0.5 limb reduction defects, and 0/0.5 hypospadias. These data do not support an association between the drug and congenital defects.

Breast Feeding Summary

No reports describing the use of cromolyn sodium during lactation have been located.

References

1. Dykes MHM. Evaluation of an antiasthmatic agent cromolyn sodium (Aarane, Intal). JAMA 1974;227:1061–2.
2. Greenberger P, Patterson R. Safety of therapy for allergic symptoms during pregnancy. Ann Intern Med 1978;89:234–7.
3. Weinstein AM, Dubin BD, Podleski WK, Spector SL, Farr RS. Asthma and pregnancy. JAMA 1979;241:1161–5.
4. Pratt WR. Allergic diseases in pregnancy and breast feeding. Ann Allergy 1981;47:355–60.
5. Mawhinney H, Spector SL. Optimum management of asthma in pregnancy. Drugs 1986;32:178–87.
6. Niebyl JR. Drug Use in Pregnancy. Philadelphia, PA:Lea & Febiger, 1982:53.
7. Cox JSG, Beach JE, Blair AMJN, Clarke AJ. Disodium cromoglycate (Intal). Adv Drug Res 1970;5:135–6. As cited in Shepard TH. Catalog of Teratogenic Agents. 6th ed. Baltimore, MD:Johns Hopkins University Press, 1989:174.
8. Product information. Intal. Rhone-Poulenc Rorer Pharmaceuticals, 2000.
9. Shepard TH. Catalog of Teratogenic Agents. 6th ed. Baltimore, MD:Johns Hopkins University Press, 1989:174.
10. Wilson J. Use of sodium cromoglycate during pregnancy: results on 296 asthmatic women. Acta Therap 1982;8(Suppl):45–51.

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