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Clinical Investigations: PREGNANCY |

The Safety of Dextromethorphan in Pregnancy*: Results of a Controlled Study

Adrienne Einarson, RN; Dorothy Lyszkiewicz, BSc; Gideon Koren, MD
Author and Funding Information

*From the Motherisk Program, Division of Clinical Pharmacology, The Hospital for Sick Children, University Of Toronto, Ontario, Canada.

Correspondence to: Adrienne Einarson, The Motherisk Program, Division of Clinical Pharmacology, The Hospital for Sick Children, 555 University Ave, Toronto, M5G 1X8, Ontario, Canada; e-mail: einarson@sickkids.on.ca



Chest. 2001;119(2):466-469. doi:10.1378/chest.119.2.466
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Background: Dextromethorphan (DM), the d-isomer of the codeine analog levorphanol, is an active ingredient present in a variety of cough and cold remedies. Recently, data generated from a study in chick embryos were extrapolated to suggest that pregnant women should not use this drug because of the risk of birth defects. We conducted a controlled study of pregnant women who used DM, to examine the possible teratogenic risk in humans.

Materials and methods: We followed up women who used DM and had been counseled by the Motherisk Program during their pregnancy. A control group of women was matched for age, smoking, alcohol use, and disease state (upper respiratory tract infection, not treated with DM).

Results: We were able to ascertain pregnancy outcome in 184 women. There were 172 live births, 10 spontaneous abortions, 1 therapeutic abortion, and 1 stillbirth. One hundred twenty-eight of the women used the drug during the first trimester of pregnancy. There were three major malformations (2.3%) among the babies of women who used DM in the first trimester, seven minor malformations, and the mean (± SD) birth weight was 3,381 ± 670 g. In the control group, there were 174 live births, 8 spontaneous abortions, and 2 therapeutic abortions. There were five major malformations, one of which was a chromosomal abnormality (2.8%), eight minor malformations, and the mean birth weight was 3,446 ± 571 g.

Conclusion: This study fails to show that DM use during pregnancy increases the rates of major malformations above the expected baseline rate of 1% to 3%.


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