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Safety of Dextromethorphan.
Dextromethorphan, the active ingredient in many over-the-counter cough and cold remedies, is probably the most widely used: anticoughing ingredient in the world. More than 70 cough and cold and flu products containing dextromethorphan are listed in the 2000 Physicians' Desk Reference for Nonprescription Drugs and Dietary Supplements, including several Robitussin, Vicks, and Triaminic products.
Dextromethorphan (DM) is an isomer of the codeine analogue levor- phanol and suppresses cough without the addictive properties of codeine and opioids. Up until about 3 years ago, DM was not perceived as a risky drug to take during pregnancy, although this perception was based on a small amount of human data. Some of this data came from the Boston Col- laborative Perinatal Project, which prospectively followed more than 50,000 mother-child pairs. The study did not detect an increase in major malformations among the babies of the 300 women who took DM during the first trimester of pregnancy.
But in 1998 the publication of a study that used a chick embryo model caused a great deal of havoc among teratologists, obstetricians, and others who care for pregnant women. The investigators exposed incubated chick embryos to DM during the time of neural tube closure and found evidence of neural crest and neural tube defects in the embryos that survived (Pediatr. Res. 43[1]:1-7, 1998). Extrapolating their results in a nonmammalian model to humans, they proposed that DM may have the same effects in humans.
In response, we began our own study, as did other investigators. In our prospective cohort study, we followed 184 mostly Canadian women who were counseled by the Motherisk Pro gram about the use of or exposure to a DM containing product during pregnancy. We compared them with a matched control group of pregnant women exposed to agents that do not pose a risk to the fetus. (The study was supported by five companies that market products that contain DM.)
Among the 128 women who took DM-containing products during the first trimester, there were three major malformations--for a 2.3% rate that was similar to the control group and within the expected rate of ...
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Source: HighBeam Research, Safety of Dextromethorphan.