Drug labeling and risk perceptions of teratogenicity: A surrey of pregnantCanadian women and their health professionals

There is a general perception that medicinal drugs are not safe in pregnanc y despite the fact that fewer than 30 drugs have been shown to cause major malformations in humans. A large number of women need medications in pregna ncy to treat pregnancy-induced conditions, acute illnesses, and chronic dis eases. The objectives of this study were the following: (1) to characterize the perception of teratogenic risk by pregnant women and their partners an d by health professionals and (2) to examine the most reassuring way to pre sent data on a drug for nausea and vomiting of pregnancy that has been prov en to be safe to the fetus. A convenience sample of pregnant Canadian women and their partners, pharmacists, nurses, physicians, and hospital workers were asked to choose the "safest" among four drugs by statements describing their safety. Although the text of all four was similar, the title and nar rative were modified to be more or less "reassuring" by the use of more or less terms such as malformations and abnormalities. Health professionals ra ted the teratogenic risk significantly lower than the parents, but even the y rated the drugs as nor safe, despite a scientifically reassuring text. Si xty percent of the 240 participants, regardless of their perception of tera togenic risk, believed the four drugs were of similar risks. However, in th e other 40%, the less "reassuring" text led to higher teratogenic perceptio n, and the more reassuring options tended to decrease the false perception of teratogenic risk. It was con eluded th at in general, four different ver sions of reassuring text describing a scientifically proven safe drug in pr egnancy did not lead expecting parents to believe they were safe. Among tho se who did not rank the four drugs as having equal safety/risk, the less "r eassuring" text led to a higher perception of teratogenic risk. Even health professionals reading the labels describing safe drugs rated them as unsaf e. Presently, the perception of teratogenic risk is strong even for safe dr ugs and is difficult to change even with evidence-based facts.