Prospective, controlled, multicentre study of loperamide in pregnancy
Loperamide (Imodium, Janssen-Ortho Inc, North York, Ontario/McNeil Consumer Products, Guelph, Ontario) is a synthetic piperidine derivative used for the treatment of both acute and chronic diarrhea. It exerts its action via cholinergic, noncholinergic, opiate and nonopiate receptor-mediated mechanisms. After oral administration, little systemic absorption takes place. About 40% ofa2 mg dose is excreted in the feces, with about 30% being unchanged drug. Reproductive studies performed in the rat and rabbit revealed no evidence of impaired fertility or harm to the fetus at dose levels up to 30-fold the therapeutic dose for humans. This drug is commonly used for both acute and chronic conditions, such as travellers’ diarrhea and inflammatory bowel disease. There are limited human data available on the use of this drug in pregnancy.
In a surveillance study of Michigan Medicaid patients, 108 pregnant women were exposed to this drug during the first trimester. There were six major birth defects, three of which were cardiovascular abnormalities. Because of the limitations of this study, such data are not sufficient to counsel women on the safety and risk of this drug in pregnancy. Because at least 50% of pregnancies are unplanned, it is likely that this drug may be used in early pregnancy. Because of this paucity of information, we decided to carry out this study to ascertain further the risk and safety for women consuming this drug during pregnancy.
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