Rare Cases of Liver Injury Reported with Use of Orlistat (Xenical®)


Orlistat is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) ≥ 30 kg/m2 and overweight patients (BMI ≥ 28 kg/m2) with associated risk factors such as type II diabetes, hyperlipidemia and hypertension. Also, Orlistat is indicated in patients who fail to respond adequately to suitable weight reducing measures, orlistat can be used as an adjunct to a hypocaloric diet and physical measures in the treatment of dietary overweight.
The Saudi Food and Drug Authority (SFDA) advises healthcare professionals and consumers about potential rare occurrences of severe liver injury in patients taking the weight-loss medication orlistat, marketed as Xenical.
Information for Patients and Consumers
• Be aware that cases of severe liver injury have been reported rarely in people taking Orlistat, marketed as Xenical®.
• Contact your healthcare professional if you develop itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. These may be signs of liver injury.
• Talk to your healthcare professional about any concerns you have with these medications.
• Report any side effects with Xenical and other products to SFDA.

Considerations for Healthcare Professionals
• Be aware that post marketing cases of severe liver injury with hepatocellular necrosis or acute hepatic failure have been reported rarely in people using Xenical. Some of these cases resulted in liver transplant or death.
• Weigh the benefits of weight-loss with Xenical against the potential risks when determining if these medications are appropriate for patients.
• Instruct patients to report any symptoms of hepatic dysfunction (anorexia, pruritus, jaundice, dark urine, light colored stools, or right upper quadrant pain) when using this medication.
• If liver injury is suspected, orlistat and other suspect medications should be discontinued immediately and liver function tests and ALT and AST levels obtained.

Report Adverse Drug Reactions to the SFDA:
Healthcare professionals Are highly encouraged to report all adverse drug events or product quality issues related to Xenical® to Saudi Food and Drug Authority. Reports can be submitted via either of the followings:
The National Pharmacovigilance Centre
Saudi Food and Drug Authority-Drug sector
3292 Northern ring road- Alnafal district
Riyadh 13312-9288
Telephone: 01-2759222 Ext: 2334, 2353, 2352, 2354, 2356, 2317, or 2340
Fax: 01-2107398
Email: npc.drug@sfda.gov.sa
Online: www.sfda.gov.sa/npc