The FDA has issued a warning that the popular Alli diet pill may cause a severe liver injury. The move comes three years after GlaxoSmithKline began marketing Alli as an over-the-counter version of Xenical, a prescription drug marketed by Roche (
) which, you may recall, fared poorly due to side effects such as leakages and oily discharges. Both contain the active ingredient known as orlistat.
In explaining its decision, the FDA said it identified 13 cases of severe liver injury, with 12 coming from outside the US. The one case in the US involved Alli. Two patients died from liver failure and three required transplantation, although the agency emphasized that a cause-and-effect relationship has not been established (you can read more here).