Kidney Injuries Link To Alli Researchers in Canada have found a link to kidney injuries in people taking GlaxoSmithKline’s Alli, a lower-dose, over-the-counter version of Roche’s Xenical. Alli’s active ingredient is orlistat.
The research team reviewed healthcare databases from Ontario and discovered that 0.5 percent of new orlistat users required hospitalization for kidney problems in the same year they began taking the medication. That number increased to two percent in the following year of treatment.
Alli, sold over-the-counter without a prescription, contains 60 mg of orlistat. The U.S. Food and Drug Administration (FDA) first approved Alli in 2007. Xenical, approved in 1999 requires a prescription and contains 120 milligrams of orlistat. In 2010, the safety labels for Xenical and Alli were modified to include information about potential rare occurrences of severe liver injury in patients. At that time, the popular Alli and Xenical were used by about 40 million people worldwide.
Alli works not by suppressing appetite or increasing metabolism, but by reducing fat absorption in the body, and are meant for use with a low-fat diet. Alli became enormously popular as soon as it hit stores with global sales that totaled about $317 million in 2009.
FDA Review Orlistat
In 2009, the FDA began a safety review of orlistat following reports of 32 cases of serious liver injury, including six cases of liver failure between 1999 and October 2008. Two cases occurred in the United States and in 27 cases, patients’ reactions were so serious that hospitalization was needed. According to the FDA, its review identified 13 total reports of severe liver injury with orlistat. Twelve reports took place overseas with Xenical and one report in the United States involved Alli; two patients died and three required liver transplantation.
Because of the seriousness of severe liver injury, the FDA said it added information about reported cases of severe liver injury to Alli and Xenical labels to educate the public about the signs and symptoms of liver injury and the need to see a physician promptly should they occur. Symptoms include such as itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools.