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Recently, the US FDA issued Early Communication about Ongoing Safety Review of Weight Loss Drug Orlistat

• Background and in the United States (U.S.)
The U.S. Food and Drug Administration (FDA) announced on 24 August 2009 that it is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical™ (Orlistat 120mg capsules) and the over-the-counter medication Alli™ (60mg capsules, available in the U.K. and U.S.). Thirty-two reports of serious liver injury, including 6 cases of liver failure, were reported via the FDA’s Adverse Event Reporting System between 1999 and October 2008. Thirty of the 32 reports occurred outside the United States. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain. Hospitalization was reported in 27 of the 32 cases.

In addition, the U.S. FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury. No definite association between liver injury and orlistat has been established at this time.

• In the United Kingdom
The Medicines and Healthcare products Regulatory Agency (MHRA) received 1,295 reports of suspected adverse drug reactions (ADRs) associated with orlistat since it was licenced in 1998. Of these, 137 were suspected hepatic ADRs (including 2 cases with a fatal outcome) linked to orlistat. A single case of abnormal liver function tests has been reported for Alli™. The MHRA is continuing its surveillance.

• Local reports received,
In Singapore, orlistat has been approved for use as a Prescription-only item since 10 June 1999. Made available as a Pharmacy-only item from 31 Jan 2005, orlistat may be purchased in limited quantities from a Pharmacist if the patient fulfils certain predetermined criteria. 

Since the year 2000, the Health Sciences Authority (HSA) has received four adverse reaction reports suspected to be associated with orlistat.  Two of the 4 were liver injury reports, but the link between the liver injuries and the use of orlistat could not be conclusively established due to incomplete information and the presence of confounding factors. HSA will continue to follow the US FDA's investigation closely.

• Recommendations by Pharmaceutical Society of Singapore:
The U.S. FDA1 and Singapore HSA3 advise that consumers who are taking orlistat may continue to take it as prescribed or directed. Conclusive evidence that orlistat led to liver injuries in the above-mentioned reports is lacking.
Until more information is available, the Pharmaceutical Society of Singapore (PSS) advises consumers that discontinuation of orlistat treatment in the absence of signs and symptoms of liver injury is premature. However, consumers who are concerned should discuss this matter with their doctor or pharmacist. Where appropriate, explore a different treatment option for the management of obesity. In the meantime, monitor for signs and symptoms of liver injury. Consumers should seek medical advice if they experience the following symptoms: weakness or fatigue, fever, jaundice, abdominal pain, nausea, vomiting, loss of appetite or brown urine. In addition,  healthcare professionals  should report suspected adverse drug reactions from the use of orlistat to the Pharmacovigilance Branch , Health Sciences Authority.

For more information, please contact Pharmaceutical Society of Singapore. Email: admin@pss.org,sg  or Tel. 6221 1136

If further clarifications is required:
1) Pharmacist or healthcare professional may contact Mr Choong Chih Tzer at 6866 3548 or email to choong?chih?tzer@hsa.gov.sg

2) Consumers who need to contact HSA should be directed to the general enquiry line 6213 0838 or email hsa?info@hsa.gov.sg

Contributed by:
Christine Teng
103rd PSS Council