Do not feed the thickening product called SimplyThick to infants born before 37 weeks because it may cause a life-threatening condition.
This advice to parents, caregivers, and health care providers from the Food and Drug Administration (FDA) is based on reports of infants with necrotizing enterocolitis (NEC) in which tissue in the intestines becomes inflamed and dies.
SimplyThick is a brand of thickening agent—available to consumers and medical centers—to help manage swallowing difficulties. It...
FDA has identified and reviewed 12 cases of severe liver injury reported in people taking Xenical and one case reported with the use of Alli. In some of these cases, other factors or drugs may have contributed to the development of severe liver injury.
A cause-and-effect relationship of severe liver injury with orlistat use has not been established; however, because of the seriousness of this possible side effect, FDA has revised the drug labels for Xenical and Alli to include new safety information about the rare occurrence of severe liver injury.