FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury
The FDA has approved labeling changes for the over-the-counter weight loss drug alli (orlistat) to include warnings regarding the risk of kidney stones and kidney injury.
This affects the manufacturer of the OTC drug alli, healthcare providers advising patients on weight loss, and regulatory professionals responsible for consumer drug labeling and post-market surveillance.
The requirement for a labeling change suggests that post-market data has identified a significant safety signal regarding renal health associated with orlistat use. For regulatory professionals, this indicates a shift in the benefit-risk profile for this OTC product, necessitating immediate updates to compliance documentation and consumer safety information to mitigate liability and ensure informed use.
Regulatory teams should ensure all consumer-facing packaging and Drug Facts labels are updated to reflect the new kidney stone and kidney injury warnings. Pharmacovigilance departments should monitor post-market reports for renal-related adverse events to identify any further safety signals. QA should verify that existing stock and new production runs comply with these labeling requirements.
FDA Drug Safety Communication: FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury. Source: https://www.fda.gov/drugs/drug-safety-communications/fda-approves-labeling-changes-over-counter-otc-weight-loss-drug-alli-orlistat-warn-risk-kidney
Open in openFDA / FDA.gov