The national law firm, Parker Waichman LLP, is investigating cases involving the popular weight loss drugs, Alli and Xenical, and their links to permanent kidney damage, liver damage, and other organ damages. Xenical (Orlistat) is the prescription version of the trendy over-the-counter (OTC) drug, Alli.
A just-released study discussed kidney, liver, and other types of organ damage associated with both versions of the orlistat-containing weight loss drugs. The strongly worded findings were issued based on a study conducted by the University of Rhode Island and funded by the National Institutes of Health (NIH) and warned of
“severe toxicity” to major organs, according to Forbes.
The research results, which were obtained by renowned pharmacology professor, Bingfan Yan, were serious enough, in his opinion, that he immediately reported the results to the U.S. Food & Drug Administration (FDA), said Forbes. Yan, a highly respected pharmacologist, is well known for discovering a number of dangerous drug interactions and is also one of the authors of the Encyclopedia of Drug Metabolism and Interactions.
Xenical and Alli Diet Medications
The FDA approved orlistat in 1999 and Alli in 2007. Xenical’s active ingredient Orlistat, is also the active ingredient in GlaxoSmithKline’s Alli, the OTC version of the diet drug. Prescription Xenical contains 120 milligrams of orlistat, while OTC Alli contains 60 mg of orlistat. Xenical and Alli work differently than other diet medications in that they reduce fat absorption in the body, versus speeding up metabolism or suppressing appetite as do other diet aids. Forbes noted that orlistat blocks lipase, the fat-digesting enzyme found in the intestines. The notion behind the drug is that more undigested fat will pass through the body without having to be digested.
While liver and kidney damage, sometimes permanent, are certainly serious issues, Yan’s team also discovered that orlistat’s metabolic action mitigates the efficacy of many drugs, including life-critical cancer treatments. Cancer cells multiplied faster when orlistat was taken, said Forbes. The study also found that orlistat increased aspirin’s anti-clotting effects, which increased risks for both external and internal bleeding. Other long-known side effects linked to Xenical and Alli include the inability to control one’s bowels, stools that are oily or fatty, and oil spotting.
In fact, Yan’s team reported that, even at low doses, orlistat limits function of an important enzyme—carboxylesterase-2—which is critical in detoxifying the liver, kidneys, and the entire gastrointestinal tract. Should carboxylesterase-2 be unable to function appropriately, said the researchers, “severe toxicity of internal organs,” may occur, said Forbes. Worse, if orlistat’s activity can interfere with one metabolic enzyme, it likely can impact others, as well. Some results were published in Biochemical Pharmacology and the University of Rhode Island also issued an announcement with more detailed results.
Serious Liver Injuries Reported
In 2010, the safety labels for Xenical and Alli were modified to include information about potential rare occurrences of severe liver injury in patients, according to the FDA. The FDA began a safety review of orlistat in 2009, following reports of 32 cases of serious liver injury, including six of liver failure between 1999 and October 2008; two cases were reported in the United States. For 27 patients, the symptoms were severe enough to require hospitalization. When the FDA completed its review, it also identified to related patient deaths and three patients who needed liver transplantation. Because of the severity of liver injury, the FDA said it added information about reported cases of severe liver injury to Xenical and Alli labels; however, there are concerns that the warnings are not sufficiently strong.
Now, new data on orlistat’s potential toxicity to the kidneys, liver, other organs, and the gastrointestinal tract, in general, has recently emerged, an issue of some significant concern given that, just two years ago, Xenical and Alli were used by some
40 million people worldwide.
Previously, Public Citizen urged the FDA to ban both Xenical and Alli over known liver, pancreas, and kidney risks, which they say outweighs the drugs’ benefits. Of 73 cases Public Citizen identified involving kidney stones associated with Alli or Xenical; 23 required hospitalization. Also, 47 reported cases of acute pancreatitis linked to the drugs were found on FDA’s adverse event reports. This was the second petition Public Citizen made to the FDA to remove Xenical from the market; the agency rejected the first petition.
Public Citizen director, Sidney Wolfe, MD, has warned consumers not to wait for the FDA. “Stop taking them!” he has said of Xenical and Alli. Unlike other drugs, which may have a withdrawal syndrome that patient’s would suffer when suddenly stopping a medication, there is no downside to stopping Xenical or Alli.