Safety Alerts & Recalls
What does this mean?
At this time, the FDA has not made any conclusions about these reports of liver-related adverse events in patients taking Orlistat. The FDA is advising patients to continue treatment with Orlistat as directed. However, it is a good idea to follow up with your doctor at your next appointment to review the benefits and risks of treatment with Orlistat, including this new safety information that may suggest a risk of liver-related adverse events with taking Orlistat. For most patients, the benefits of Orlistat will continue to outweigh the risks.
If you are experiencing or develop symptoms associated with liver injury, including weakness or fatigue, fever, yellowing of the skin or whites of the eyes, brown urine, abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite, you should contact your doctor as soon as possible.
Early Communication about an Ongoing Safety Review for Orlistat (marketed as Alli and Xenical)
FDA is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat, a medication used for weight loss and weight management. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli.
Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to the FDA's Adverse Event Reporting System. The most commonly reported adverse events described in the reports were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain.
In addition to the 32 reported cases, the FDA is reviewing other information on suspected cases of liver injury submitted by the manufacturers of orlistat. FDA's analysis of this information is ongoing and no definite association between liver injury and orlistat has been established at this time. The FDA will follow up with additional information once the review is complete.
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