NPC Archive Item: FDA reviews the safety of Orlistat

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22 September 2009

The FDA is reviewing the safety information for Orlistat following reports of serious liver injury. However, no definite association between liver injury and orlistat has been established at this time.

At this time, healthcare professionals do not need to change their prescribing practices with orlistat. Prescribers of Xenical® should continue to note the warnings in the Summary of Product Characteristics (SPC) and people using over-the-counter alli® should continue to use the product as recommended by the manufacturer.

People currently taking orlistat should consult their doctor or pharmacist if they are experiencing symptoms possibly associated with the development of liver injury, particularly weakness or fatigue, fever, jaundice or brown urine. Other symptoms of liver injury may include abdominal pain, nausea, vomiting, light-coloured stools, itching, or loss of appetite.

Any healthcare professional or member of the public who suspects an adverse effect related to the use of orlistat should report this to the MHRA via their yellow card scheme.

In the USA and the UK, orlistat is available on prescription as Xenical® (orlistat 120mg) and over the counter as alli® (orlistat 60mg) for weight loss in overweight adults, in conjunction with a reduced-calorie and low-fat diet.

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 were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain. Hospitalisation was reported in 27 of the 32 cases.

As reported in the Pharmaceutical Journal, in the UK, the MHRA is also monitoring the safety of orlistat, in line with its policy to review the safety of all medicines. Since the drug was licensed in 1998, the MHRA has received 1,295 reports of suspected adverse drug reactions (ADRs) possibly associated with orlistat, including 20 reports linked to alli® (marketed in the UK since April 2009). Among these, the MHRA has received reports of 137 suspected hepatic ADRs (including two cases with a fatal outcome). A single case of abnormal liver function tests has been reported for alli®.

Key safety information to support the availability of orlistat in pharmacies was published by the MHRA in the May 2009 issue of Drug Safety Update.

More information on orlistat can be found on the obesity section of NPC.

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