FDA orders label changes for Alli, Xenical
The US Food and Drug Administration issued a drug safety communication Wednesday requiring all orlistat products to carry warnings about the risk of kidney stones and acute kidney injury. The label change applies to over-the-counter Alli (60 mg) and prescription Xenical (120 mg). Consumers with a history of kidney disease or kidney stones are advised to consult a healthcare provider before using the drug. The FDA identified 12 cases of kidney complications from 2007 to 2023, with patients averaging 61 years old.
Moderate to severe complications reported
Of the 12 cases reviewed, eight involved acute kidney injury, two reported AKI with oxalate nephropathy, and two had hyperoxaluria with calcium oxalate kidney stones. Eight patients required hospitalization and five needed dialysis. Seven patients improved, while outcomes for others were not reported. 'The risk of renal injury is now described consistently across the labeling for all FDA-approved orlistat products,' the FDA stated. The agency noted that the actual number of cases may be higher due to underreporting.
Broader health news: GLP-1s and cancer risk
In other health news, a large study published this week found that GLP-1 receptor agonists are associated with a lower risk of multiple cancers, adding to the growing list of potential benefits for the popular drug class. Separately, researchers found that glucosamine supplements may be tied to faster cognitive decline in people with established Alzheimer's disease, and the American Medical Association delegates voted to fund studies comparing care from physicians versus nurse practitioners and physician assistants.