Orlistat and post-marketing reports of severe liver injury

The HSA’s Vigilance Department want to replace healthcare professionals on the post-marketing experiences of liver accidents related to the usage of orlistat. Orlistat is a potent inhibitor of gastrointestinal lipases thereby lowering the ingested dietary fats absorption and whole vitality consumption to provide weight reduction.

Orlistat is registered in Singapore underneath the commerce names of Alli® (GSK) and Xenical® (Roche). Xenical® has been registered domestically since 1999 and is indicated for the therapy of overweight sufferers with a physique mass index (BMI) ≥30 kg/m2, or obese sufferers (BMI ≥ 28 kg/m2) with related threat elements, along with a mildly hypocaloric weight-reduction plan. Alli® has been licensed to be used domestically in 2010, with the identical indication as Xenical, and it’s for use in adults aged 18 years and over, together with a reduced-calorie and low-fat weight-reduction plan.

Evaluations carried out by drug companies up to now


The US Meals and Drug Administration (FDA) has accomplished its evaluate of the experiences of great liver accidents related to the usage of Xenical® and Alli®.1 The company had recognized a complete of 13 experiences of extreme liver damage related to the usage of these orlistat-containing medicines: 12 international experiences with Xenical® and one U.S. report with Alli®. Of those 13 circumstances, two sufferers died from liver failure whereas three sufferers required liver transplantation. The FDA reported {that a} causal relationship between extreme liver damage and the usage of orlistat has not been established. This causality hyperlink was troublesome to ascertain as these experiences of extreme liver damage had occurred over a interval of 10 years, throughout which an estimated 40 million individuals worldwide may have consumed orlistat. A number of the sufferers within the reported circumstances had additionally taken different drugs or had different medical situations that will have contributed to the event of extreme liver damage.

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The FDA has included data relating to the circumstances of extreme liver damage to the label of Xenical® and Alli®. That is to extend the notice among the many healthcare professionals on these post-marketing circumstances of extreme liver damage related to the usage of orlistat and to teach sufferers utilizing these medicines concerning the indicators and signs of liver damage.


A Europe-wide evaluate on the doable affiliation between critical hepatic reactions and orlistat use was carried out in July 2009.2 The information that was reviewed included non-clinical, medical trial, post-marketing security information offered by the product licence holders and suspected opposed response experiences submitted to the UK Medicines and Healthcare merchandise Regulatory Company. The European evaluate concluded that there was inadequate proof to indicate that both Xenical® or Alli® had been related to extra critical liver problems than these at the moment listed within the product data (reminiscent of hepatitis, cholelithiasis, elevated transaminases) and no additional regulatory motion was advisable.


In August 2009, the Vigilance Department, HSA undertook a security evaluate of the circumstances of hepatic problems related to the usage of Xenical® that had been submitted to the FDA. It was discovered that over 50% of those drug-induced hepatic experiences had been confounded by means of concurrent medicines (e.g. alcohol, paracetamol, statins) or underlying medical situations reminiscent of weight problems and gallstones.

Native circumstances

Since 2000, HSA has obtained two native experiences of liver toxicities suspected to be related to the usage of orlistat. The primary case was reported in 2000, which described a case of jaundice and fulminant liver failure with large hepatocellular necrosis in a 62 year-old man.3 Nevertheless, the causality of liver failure was unclear because the affected person was additionally taking paracetamol. A second case was reported in 2002, whereby the affected person was reported to have elevated liver enzymes.

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HSA’s advisory

The native affected person data leaflets and bundle inserts of each Xenical®and Alli® at the moment carry warnings on the doable threat of hepatic-related opposed results related to the usage of these medicines.

In view of the potential for uncommon however extreme liver accidents, it’s endorsed that healthcare professionals think about the advantages and dangers related to the usage of orlistat earlier than prescribing or recommending these drugs to their sufferers. Healthcare professionals are suggested to tell their sufferers to cease the usage of orlistat and search medical consideration instantly in the event that they expertise signs that could be probably related to liver damage, reminiscent of fever, jaundice, or brown urine. Healthcare professionals are inspired to report any opposed drug reactions which might be suspected to be related to the usage of orlistat to the Vigilance Department of HSA.


  1. FDA Drug Security Communication http://www.fda.gov/Medication/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213038.htm
  2. MHRA Drug Security Replace: Quantity 3, Concern 7, February 2010 http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON071085
  3. Med Sci Regulation 2002, 42: 309-12

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Source: https://www.hsa.gov.sg/announcements/safety-alert/orlistat-and-post-marketing-reports-of-severe-liver-injury

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