The Food and Drug Administration has announced it is reviewing adverse reports of liver injury in patients taking the weight loss drug orlistat, also known as Xenical or Alli.
Over a 9 year period starting in 1999, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those reports, 27 reported hospitalization and six resulted in liver failure. The most commonly reported side effects included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.
The FDA is performing an analysis of data from clinical trials and the manufacturer these data. To date no definite association between liver injury and orlistat has been established. The FDA will release its findings on orlistat as soon as the review is completed and is not recommending to stop taking the medication at this time.
If you have used or continue to use orlistat you should consult a health care professional if you experience symptoms possibly associated with development of liver injury: weakness or fatigue, fever, jaundice, or brown urine. Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.
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