FDA Updates Alli Label to Warn of Rare but Potentially Fatal Kidney Problems
The FDA has approved updated labeling for Alli, an over-the-counter weight loss pill, to warn of rare risks including acute kidney injury, kidney stones, and oxalate nephropathy. The agency now instructs people with kidney disease history to consult a doctor before use and directs all users to stop taking the drug if they experience symptoms like back pain, blood in urine, or leg swelling. This warning is significant because Alli is the only OTC weight loss medication available in the U.S., and approximately 40 million people have used orlistat (Alli's generic form) since its approval in 1999.
The Food and Drug Administration has approved changes to the drug facts label for Alli's 60 mg capsules to highlight potential kidney complications, including acute kidney injury, kidney stones, and oxalate nephropathy—a condition involving calcium oxalate crystal deposits in kidney tubules that can cause injury and fibrosis. The updated label now requires consumers with a history of kidney disease or kidney stones to consult a healthcare provider before use, and instructs all users to discontinue the medication if they develop back or groin pain, blood in urine, painful urination, or leg swelling. The FDA emphasized that severe untreated cases of acute kidney injury can be fatal. Alli, the brand name for the generic drug orlistat, remains the only over-the-counter weight loss medication available without prescription in the U.S. since its approval in 2007. Medical experts, including the Mayo Clinic and British NHS, have previously warned against using Alli without professional supervision due to concerns about drug interactions, vitamin deficiencies, gastrointestinal side effects, and serious complications affecting liver, kidney, and gallbladder function.
What's missing
The specific number of adverse kidney-related events reported to the FDA that prompted this label update is not provided. Additionally, the timeline for when these kidney complications were first identified or reported is absent from the article.
What different sources said
- ForbesCenter
FDA Warns Alli—An Over-The-Counter Weight Loss Pill—Could Cause Fatal Kidney Problems
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