Loperamide bloody diarrhea. In 1990, all formulations for children of the antidiarrheal loperamide were banned in Pakistan. Loperamide is not recommended in the UK for use during pregnancy or by nursing mothers. In the US, loperamide is classified by the FDA as pregnancy category C. Studies in rat models have shown no teratogenicity, but sufficient studies in humans have not been conducted. One controlled, prospective study of 89 women exposed to loperamide during their first trimester of pregnancy showed no increased risk of malformations. This, however, was only one study with a small sample size. Loperamide can be present in breast
Loperamide first clinical reports on loperamide were published in 1973 in the" Journal of Medicinal Chemistry" with the inventor being one of the authors. The trial name for it was "R-18553". Loperamide oxide has a different research code: R-58425. The trial against placebo was conducted from December 1972 to February 1974, its results being published in 1977 in "Gut", an edition of British Society of Gastroenterology. In 1973, Janssen started to promote loperamide under the brand name Imodium. In December 1976, Imodium got US FDA approval. During the 1980s, Imodium became the best-selling prescription antidiarrheal in the United States. In March