The FDA has approved labeling changes for the over-the-counter weight loss drug alli (orlistat), specifically its 60-milligram capsules, to warn consumers about the risk of acute kidney injury, a rare side effect associated with the medication.
The FDA reviewed adverse event reports and medical literature from alli’s approval on Feb. 9, 2007, through Dec. 31, 2023, according to a June 10 FDA news release. The agency identified 12 cases of kidney complications associated with alli use, including eight reports of acute kidney injury, two reports of acute kidney injury with oxalate nephropathy and two reports of hyperoxaluria with calcium oxalate kidney stones.
Among the 12 cases, eight patients required hospitalization and five required dialysis. Based on the postmarketing reports and evidence suggesting the risk may occur at both prescription and nonprescription doses, the FDA added the kidney injury warning to the drug’s label.
The updated Drug Facts label advises consumers to ask a healthcare provider before using alli if they have ever had kidney disease or kidney stones. It also instructs consumers to stop using the drug and consult a physician if they develop symptoms of kidney injury or kidney stones, including back or groin pain, painful urination, blood in the urine, feet and leg swelling or less frequent urination.
The agency said the labeling changes align kidney injury warnings across all FDA-approved orlistat products, including over-the-counter alli and prescription-strength Xenical (orlistat) 120-milligram capsules.
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