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FDA Updates Alli Label Amid Kidney Concern Fears
11 Jun
Summary
- FDA warns of rare kidney problems linked to Alli over-the-counter drug.
- Updated label advises users with kidney history to consult a doctor.
- Concerns exist over potential damage despite modest weight loss results.

The U.S. Food and Drug Administration has mandated updated labeling for Alli, the nation's only non-prescription weight loss medication, to reflect serious kidney-related side effects. The revisions highlight risks including acute kidney injury, kidney stones, and oxalate nephropathy. Users with a prior history of kidney problems are now instructed to seek medical advice before commencing treatment.
Further precautions include immediate cessation of Alli if users experience back or groin pain, blood in urine, painful urination, or leg swelling, as severe, untreated kidney injuries can be fatal. Alli's existing warnings already cautioned against use by transplant recipients and advised those with gallbladder issues or certain other conditions to consult a physician.
Despite its availability over-the-counter since 2007, medical experts have long cautioned against unsupervised use of Alli, citing potential drug interactions, nutrient deficiencies, gastrointestinal issues, and severe organ complications. Critics argue the drug offers minimal weight loss benefits while posing significant health risks.