Prospective, controlled, multicentre study of loperamide in pregnancy: DISCUSSION
This is the first prospective, controlled study of loperamide in pregnancy to date. The results do not support the findings in the previous study with the Michigan Medicaid patients. In that study, which was a surveillance study with no personal interviews of patients (108), six major malformations were found in the first trimester, three of which were cardiac anomalies, compared with our group, which found no major malformations in the first trimester. This illustrates the importance of prospective, controlled studies of exposures in pregnancy, which include history and other specifics, such as concurrent drug use, smoking and alcohol use. With that being the only report available before the present study, it is probable that women are advised not to take loperamide during pregnancy. This is reasonable, except that many women are not aware that they are pregnant when taking medications. A large number of the women who took the drug on an acute basis did not consider whether they were pregnant, with a substantial number reporting that they were on holiday in a foreign country. In previous studies and during the counselling process, women have informed us that they have had a therapeutic abortion of an otherwise wanted pregnancy based on fear of the consequences of the drug exposure on their fetus. We did not find an increase in the rates of preterm delivery, nor were the birth weights statistically significantly different, although the babies of chronic users were 200 g smaller than babies in the control group. However, this fact, in addition to the finding that half of the babies born to mothers who were exposed throughout the pregnancy weighed less than 3000 g, supports the results, as in other studies, that women with chronic bowel disease have smaller babies and should be encouraged to treat their condition with the appropriate medication during pregnancy, without fear of harming their babies.
This first prospective controlled study of loperamide in pregnancy of 105 cases, with 89 exposures in the first trimester, suggests that this drug does not increase the baseline risk of major malformations. However, an increase in teratogenic risk of some rare malformations cannot be ruled out.
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