FDA Issues Safety Alert on Weight-Loss Drug’s Kidney Risks

FDA Updates Orlistat Warnings

The FDA issued a drug safety communication approving a label change that warns about the risk of kidney stones or kidney injury with the over-the-counter (OTC) weight loss drug orlistat (Alli), the agency said Wednesday.

The label now recommends that consumers with a history of kidney disease or kidney stones consult a healthcare provider before using the drug.

Reports of Kidney Injury

The FDA advised clinicians to inform patients about reports of acute kidney injury (AKI), hyperoxaluria, calcium oxalate nephrolithiasis, or oxalate nephropathy linked to orlistat. Patients should also stop taking the drug if they develop symptoms like back or groin pain, painful urination, blood in urine, feet or leg swelling, or less frequent urination.

These events are rare, the agency noted. Mild cases of AKI may be reversible, but untreated severe cases can be fatal.


Fuente: https://www.medpagetoday.com/primarycare/obesity/121703

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