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Europe Regulators Launch New Orlistat Review

Sep 26, 2011 | Parker Waichman LLP

European regulators have launched a safety review of the orlistat-containing medications, Alli and Xenical, following more reports of liver problems linked to the drugs.  At least four of the reports involved serious liver problems in patients who had taken 120 mg orlistat (Xenical), one of which was fatal.

Both Xenical and Alli prevent fat from being absorbed by the body.  Alli is sold over the counter and contains 60 mg of orlistat, while Xenical is sold via prescription only.

Twenty-one cases of liver injury were reported between August 2008 and January 2011 among people taking 120 mg orlistat, the European Medicines Agency (EMA) said in a statement.  The four severe cases include one fatal case of hepatic failure, one case of hepatic failure leading to liver transplantation, one case of exacerbation of hepatitis and one case of hepatitis.

The EMA also found 9 reports of suspected severe liver injury with orlistat 60 mg (Alli), although in some cases other possible explanations for liver injury were present and some cases provided insufficient information to allow assessment.

The EMA pointed out that the risk of liver injury with orlistat was already known.  They are  covered in a product leaflet which contains a warning that hepatitis, cholelithiasis, and increased transaminases and alkaline phosphatase are possible side effects, and that patients who experience symptoms such as yellowing of the skin and eyes, itching, stomach pain, and liver tenderness should stop taking the capsules and tell their doctor.

In May 2010, the U.S. Food & Drug Administration (FDA) ordered that the labels of the drugs be modified to include information about potential rare occurrences of severe liver injury in patients.

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