english.prescrire.org > Spotlight > Archives : 2012 > Orlistat (Xenical°, Alli°): severe kidney and liver damage

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Orlistat (Xenical°, Alli°): severe kidney and liver damage

Orlistat, a drug used for weight loss, can cause severe adverse effects, notably kidney and liver damage.

In September 2011, the European Medicines Agency (EMA) published a report of adverse hepatic effects associated with orlistat.

Between August 2009 and January 2011, 21 cases of hepatic damage linked to orlistat 120 mg, including one death and one transplant, were reported. Between May 2007 and January 2011, 9 severe cases involving orlistat 60 mg were reported.

In 2011, a study based on figures from the Canadian health insurance system showed more frequent occurrences of acute renal failure in patients taking orlistat.

The French health products safety agency (Afssaps) has made public reports of 212 cases in France as at 20 June 2011, 33 of them deemed severe. These reports confirm the adverse effects profile already established, including effects caused by drug interactions as a result of orlistat hindering the absorption of a number of drugs such as thyroid hormone treatments and anti-epileptic drugs.

These disorders are disproportionate given the limited and temporary efficacy of orlistat.

©Prescrire 1 March 2012

"Orlistat: hepatitis and oxalate nephropathy" Prescrire Int 2012; 21 (125): 71. (Pdf, subscribers only).
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For more information:

Orlistat without a prescription:
drug interactions, pancreatitis
and kidney disorders
Prescrire Int 2010 ;
19 (107): 125.
Pdf, subscribers only

Orlistat (Alli°) available
without a prescription:
non-negligible risks for
modest weight loss
(July 2009)
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