Diet Drug Orlistat (Xenical/Alli) and kidney injury

[Guest guest]

A review of patients taking the diet drug *orlistat* (Xenical/Alli, Roche)

in Ontario, Canada over a seven-year period points to a 2% increase in acute

kidney injuries within one year of patients starting the drug [1].

The findings were reported by *Dr Weir* (University of Western

Ontario, London) and colleagues in a research letter published April 12,

2011 in the *Archives of Internal Medicine*.

Separately, drug-safety watchdog *Public Citizen* has sent a 31-page

letter<http://www.citizen.org/documents/1942.pdf>to FDA commissioner

*Dr Margaret Hamburg* demanding that the agency remove both prescription and

over-the-counter orlistat from the market, citing new data obtained from FDA

adverse-reaction files, including 47 cases of acute pancreatitis and 73

cases of kidney stones. This is the second time Public Citizen has

petitioned the FDA to pull the drug from the market.

Orlistat, which is sold as a prescription drug in Ontario (it is sold both

by prescription and over the counter, at a lower dose, in the US), has been

linked to " oxalate-induced acute kidney injury " in previous case reports.

Back in May 2010, the *FDA* issued a warning about the risks of severe liver

injury with orlistat use, based on 13 reports of liver toxicity in which two

patients died of liver failure and three required liver transplants.

Two recent reports of renal injuries prompted Ontario investigators to look

at the incidence of new reports of acute kidney injuries (acute dialysis or

a hospital diagnosis of acute kidney injury) in their province in the year

prior to patients filling orlistat prescriptions and in the year after

filling them.

Among 953 new orlistat patients identified between January 2002 and March

2008, five patients experienced an acute kidney injury event in the 12

months prior to starting on the diet drug. By contrast, 18 patients

experienced an event within 12 months after filling their prescription

(p=0.01). As a " test of specificity, " Weir et al also tracked

upper-gastrointestinal bleeding in the same fashion ( " since there is no

plausible reason why orlistat would be associated with this outcome " ) and

found no differences in rates of upper-GI bleeds before and after orlistat

prescription.

Weir and colleagues believe their analysis addresses " an important safety

issue, " although they cannot prove that the kidney injuries were a direct

result of orlistat prescription. Despite several limitations of their

analysis, they conclude: " In the appropriate setting, physicians should

consider orlistat as a potential cause of acute kidney injury. "

www.medscape.com

--

Ortiz, MS, RD

*The FRUGAL Dietitian* <http://www.thefrugaldietitian.com>

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