FDA reports rare kidney injury cases linked to Alli weight loss pill

Federal regulators issued a warning to American consumers about kidney problems potentially linked to Alli, an over-the-counter weight loss pill. U.S. Food and Drug Administration cautioned on Wednesday that taking Alli could lead to acute kidney injury in rare cases.

A safety review identified 12 cases of kidney complications linked to the drug. The FDA recommends that people with a history of kidney disease or kidney stones consult a doctor before taking Alli. Alli labeling now instructs consumers to stop using the product and ask a doctor if they develop symptoms of kidney injury or kidney stones such as back or groin pain, painful urination, blood in the urine, feet and leg swelling, or less frequent urination.

The 60-milligram capsules are approved for weight loss in adults without a prescription. Alli is manufactured by GSK. The company spun off its consumer healthcare business into Haleon in 2022. GSK directed The Independent to contact Haleon for comment.

A request for comment from Haleon was not immediately returned to The Independent. Alli first received FDA approval in 2007. It was the first over-the-counter weight loss pill approved by the FDA. The active ingredient in Alli is orlistat.

Orlistat reduces the amount of dietary fat absorbed in the intestines by approximately one quarter by blocking the enzyme lipase. The pill can be taken up to three times a day. A prescription version of orlistat exists at double the Alli dosage.

“Xenical is indicated for obesity management, including weight loss and weight maintenance, when used in conjunction with a reduced-calorie diet and to reduce the risk for weight regain after prior weight loss,” the FDA said. Risk to kidney health exists for both prescription and nonprescription doses of orlistat, according to the agency.