FDA is reviewing new safety information regarding reports of
liver-related adverse events in patients taking orlistat. Orlistat is
marketed in the United States as a prescription product, Xenical, and
as an over-the-counter (OTC) product, Alli.
Xenical (orlistat 120mg) was approved as a prescription product by
FDA in 1999 for obesity management in conjunction with a reduced
caloric diet, and to reduce the risk of regaining weight after prior
weight loss. In 2007, Alli (orlistat 60mg) was approved for OTC use for
weight loss in overweight adults, 18 years and older, in conjunction
with a reduced-calorie and low-fat diet. Currently, orlistat is
approved for marketing in approximately 100 countries. In January 2009,
a nonprescription version of orlistat was approved for sale in the
Between 1999 and October 2008, 32 reports of serious liver injury,
including 6 cases of liver failure, in patients using orlistat were
submitted to FDA’s Adverse Event Reporting System. Thirty of the 32
reports occurred outside the United States. The most commonly reported
adverse events described in the 32 reports of serious liver injury were
jaundice (yellowing of the skin or whites of the eyes), weakness, and
abdominal pain. Hospitalization was reported in 27 of the 32 cases.
In addition to the 32 reported cases, this issue was discussed at
the CDER Drug Safety Oversight Board in April 2009, and FDA is
reviewing other data on suspected cases of liver injury submitted by
the manufacturers of orlistat. FDA’s analysis of these data is ongoing
and no definite association between liver injury and orlistat has been
established at this time.
FDA is not advising healthcare professionals to change their
prescribing practices with orlistat. Consumers currently taking Xenical
should continue to take it as prescribed and those using
over-the-counter Alli should continue to use the product as directed.
Consumers should consult their health care professional if they are
experiencing symptoms possibly associated with the use of orlistat and
development of liver injury, particularly weakness or fatigue, fever,
jaundice or brown urine. Other symptoms may include abdominal pain,
nausea, vomiting, light-colored stools, itching, or loss of appetite.
FDA urges both healthcare professionals and consumers to report side
effects from the use of orlistat (Alli and Xenical) to FDA's MedWatch
Adverse Event Reporting program using the information at the bottom of
This early communication is in keeping with FDA’s
commitment to inform the public about its ongoing safety reviews of
drugs. FDA will communicate its findings to the public as soon as its
review of orlistat is complete.
CALL NOW 1-866-374-0338
if you or a loved one has been diagnosed with liver failure
after taking Alli orXenical!
You may be
entitled to monetary compensation from the manufacturer.