There may be rare occurrences of severe liver injury in patients taking active ingredient orlistat, marketed as Xenical or Alli – a weight-loss medication, says the Food and Drug Administration (FDA).
The FDA approved a revised label for Xenical, a prescription drug. The FDA says it is working with the manufacturers of Alli regarding label revisions to reflect this “rare occurrence”.
Active ingredient orlistat is present in both Xenical and Alli.
- Xenical, available only on prescription, contains 120 milligrams of orlistat
- OTC (over-the-counter, no prescription required) Alli contains 60 milligrams of orlistat
The FDA says that an estimated 40 million people around the world have taken either Alli or Xenical.
The FDA’s safety information and labeling changes are based on a examination of cases of severe liver injury reported in patients taking orlistat.
The agency has identified 13 cases of severe liver injury, only one of which was in the USA – a report of severe liver injury involving Alli.
So far, a cause-and-effect relationship of severe liver injury with orlistat use has not been established.
Consumers of Xenical or Alli should be aware that liver injury with orlistat is rare, but has been reported.
Signs and symptoms of liver injury may include:
- Itching
- Yellow eyes or skin (jaundice)
- Dark urine
- Loss of appetite
- Light-colored feces (stools)
Source: FDA
Written by Christian Nordqvist