Twelve cases of severe liver injury was identified by The Food and Drug Administration (FDA). They was reviewed based on different reports of people taking Xenical. Another reported case involved the use of Alli. Some other factors or drugs may have contributed in some of these cases to the process that generated severe liver injury.

A cause-and-effect relationship of severe liver injury with Orlistat use has not been established. However, due to the seriousness of this possible side effect, the FDA has revised the drug labels for Xenical and Alli to include new safety information about the rare occurrence of severe liver injury.

The FDA has released safety alerts concerning a number of products including a “medicated” oil containing ingredients that are poisonous, available mostly on the Internet as well as in specialty stores covering Latino and Asian communities; antacids having new safety details about a possible connection with some rare bone fractures; and weight-loss drugs which carry a new warning concerning some rare occurrence of liver failure.

All these signals were caused by reports that patients and health care professionals sent in the last year to FDA. More information about FDA warnings and recommendations can be found at www.fda.gov.

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