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
Intention-to-treat analysis be providing benefits if one merely compares the condition before and after the treatment for only those who finish the study (ignoring those who were enrolled originally, but have since been excluded or dropped out). Medical investigators often have difficulties in completing ITT analysis because of clinical trial issues like missing data or poor treatment protocol adherence. To address some of these issues, many clinical trials have excluded participants after the random assignment in their analysis, which is often referred to as "modified intention-to-treat analysis" or mITT. Trials employing mITT have been linked to industry sponsorship and conflicts of interest