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

; ; and , Motherisk Program, Division of Clinical Pharmacology, The Hospital for Sick Children, University Of Toronto, Ontario, Canada.

Disclosures

CHEST. 2001;119(2) 

In This Article

Materials and Methods

Between 1995 and 1998, > 100,000 women and/or their health professionals were counseled by the Motherisk Program. For the purpose of this study, we attempted to follow up all the women who had been counseled on the use of DM and to ascertain the outcomes of their pregnancies. During the initial interview, while they were pregnant, history of drug exposure and pregnancy was taken, as well as other medical details of interest, with the aid of a structured questionnaire. Exposure history included medical indication for drug use, dosage, frequency of administration, and timing of exposure, as well as data such as maternal demographics and obstetric history. At follow-up, the women were questioned regarding the course of their pregnancy, the health of their child, and the specific details of their exposure to DM and any other drugs or other possible exposures during their pregnancy. Outcomes were confirmed by sending a letter to the child's primary-care physician who corroborated the mother's information.

The primary outcome of interest was the rate of major malformations. Major malformations were defined by the presence of any anomaly that has an adverse effect on either the function or the social acceptability of the individual.[11] Secondary outcomes included spontaneous or therapeutic abortions, live birth or stillbirth, minor anomalies, and birth weight. Exposure was defined as occurring during organogenesis if the drug was consumed between the 4th week and 14th week of gestation.

Each woman exposed to DM was matched to a woman who also had an upper respiratory infection and had inquired about the safety of either DM or echinacea, but subsequently did not use either of them, or women who had been exposed to clarithromycin, an antibiotic considered safe for use during pregnancy.[12] The women were also matched by maternal age (± 2 years) and cigarette and alcohol consumption during their pregnancy. To assess the possibility of a selection bias, women lost to follow-up were compared with those successfully followed up for maternal age, gestational age, parity, previous spontaneous and therapeutic abortions, and cigarette and alcohol consumption, and were found to be similar. Outcomes of interest were compared between the study and control groups with the Mann-Whitney or X 2 test whenever appropriate. The protocol was approved by the Research Ethics Board of our hospital.

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