Researchers in Canada have found a link to kidney injuries in people taking Rocheâ€™s <"http://www.yourlawyer.com/topics/overview/xenical">Xenical. Xenicalâ€™s active ingredient is orlistat, which is also the active ingredient in GlaxoSmithKlineâ€™s <"http://www.yourlawyer.com/topics/overview/Alli-Orlistat-Liver-Damage-Failure-Lawsuit-LAwyer">Alli, the over-the-counter version of the diet drug.
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, said Reuters. The number increased to two percent in the following year of treatment. Prescription Xenical contains 120 milligrams of orlistat. Alli, sold over-the-counter without a prescription, contains 60 mg of orlistat. The FDA first approved Xenical in 1999, and Alli was approved in 2007.
Dr. Matthew Weir, one of the study researchers said some earlier case reports revealed kidney problems in people taking Xenical, but those reactions are not listed in the drug’s side effects, said Reuters. “I’d just like to add that this study should be interpreted cautiously,” he wrote to Reuters Health. “It is observational and cannot prove causality.” The new study looked at 953 new orlistat users and was published in the Archives of Internal Medicine, said Reuters.
“This is an important study and it illustrates that anyone taking so-called ‘weight loss’ drugs should be under the care of a trusted physician,” said Dr. Donald E. Greydanus, a pediatrician at Michigan State University, quoted Reuters, which noted that Dr. Greydanus has written on obesity, but was not involved in this study. “There is no safe panacea drug that works and that has no side effects,” he wrote to Reuters Health.
Last year we wrote that the safety labels for Xenical and Alli were being modified to include information about potential rare occurrences of severe liver injury in patients, according to the U.S. Food & Drug Administration (FDA). As of 2010, the popular weight loss medications were used by an estimated 40 million people worldwide. Xenical and Alli work by reducing fat absorption.
The FDA began a safety review of orlistat in 2009, 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. For 27 patients, the symptoms were severe enough to require hospitalization.
According to the FDA, its completed review ultimately identified 13 total reports of severe liver injury with orlistat. Twelve reports originated overseas with Xenical and one report in the United States involved Alli. Of the 13 cases, 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 Xenical and Alli labels to educate the public about the signs and symptoms of liver injury and the need to see a physician promptly should they occur. Patients who are taking either Alli or Xenical should contact their healthcare professional if they develop symptoms of liver injury, including itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools.
“I think the take-home message should be that patients on orlistat should have their kidney function carefully monitored,” Weir said, “but since orlistat is available (over-the-counter) in the US, this may be easier said than done,” he added, quoted Reuters.