Despite Earlier Warnings, Study Finds No Increased Risk From Cough Suppressant Use.(dextromethorphan use found to have no extra risk for birth defects)

2001 MAR 15 - (NewsRx.com & NewsRx.net) -- Despite earlier warnings based on animal research, a new controlled study found no extra risk of major malformations in infants of women who took dextromethorphan (DM), an active ingredient in over-the-counter common cough suppressants, during the first trimester of their pregnancy.

The results of the study were published in the February 2001 issue of Chest.

Although DM has been on the market for years, the new research findings represent the first controlled study in humans to specifically investigate this cough medication for safety during pregnancy. Prior to this investigation, a widely-publicized study based on chick embryo research had concluded that women should not use DM during pregnancy.

DM is a synthetic, non-narcotic, centrally acting cough suppressant that is available either alone in lozenges or as an oral liquid. It is also found in combination with a large number of other compounds used for upper respiratory tract infections. The study's investigators became interested in the research due to the large number of queries from pregnant women who called the Motherisk Program at the Hospital for Sick Children in Toronto after hearing about the animal research.

"A study in chick embryos concluded that women should not use DM during pregnancy," sald study co-author Adrienne Einarson. "These data, although very limited in their applicability to humans, received wide publicity, causing high levels of anxiety among pregnant women and their healthcare professionals. Because of the paucity of studies specifically examining DM, we carried out the present study to provide additional evidence-based information on pregnancy outcome following gestational exposure to this drug," she added.

Einarson, along with Gideon Koren, MD, and D. Lyszkiewicz, from the Motherisk Program, Division of Clinical Pharmacology, Hospital for Sick Children, University of Toronto, Ontario, Canada, examined 1995 to 1998 data involving 172 live births in the study group. All women who had used DM had been counseled by the Motherisk Program during their pregnancy.

Among this group, there were 10 spontaneous abortions, one therapeutic abortion, and one stillbirth. In the matched control group of mothers who did not use DM for upper respiratory infection, there ...