Study Links Increase in Kidney Injuries to Diet Drug Already Known for Liver Damage

By April 21, 2011Dangerous Drugs

In 2009, I wrote here as a dangerous drug attorney about the over-the-counter weight-loss drug Alli, known as orlistat to doctors and Xenical by prescription. The FDA began investigating Alli in 2009 after it received reports of liver damage from people who had taken it, and eventually required a black box warning on the drug’s packaging about the risk of severe liver damage. Now, a new study published in the Archives of Internal Medicine reports evidence that Alli has also been linked to increased risk of injury to the kidneys, according to an April 14 article from TheHeart.org. Separately, FDA watchdog group Public Citizen called on the FDA to ban Alli and Xenical. Manufacturer GlaxoSmithKline intends to sell the drug but not discontinue it.
Alli (the over-the-counter version of orlistat) and Xenical (the prescription version) work by reducing the body’s ability to absorb about a quarter of dietary fat intake. Dieters must still exercise and watch what they eat, however — especially since eating too much fat can cause fecal incontinence. The black box warning about liver damage came in 2010, after the FDA received at least 32 reports of liver damage linked to orlistat, including cases of liver failure that required transplants.
The Ontario doctors used medical records to identify users of orlistat (which is prescription-only in Canada) who had sought medical treatment for kidney problems. Out of 953 users, they found five who had suffered kidney problems before starting orlistat and 18 who suffered them after using the drug. To control the study, they also looked at incidences of gastrointestinal bleeding and found no difference in rates. Meanwhile, Public Citizen cited FDA data showing 73 cases of kidney stones and 47 cases of acute pancreatitis linked to orlistat use.
As a defective drug lawyer, I hope the FDA is taking both of these groups seriously. Most people would agree that they’d rather be overweight than suffer permanent organ damage — but unless orlisat’s problems are widely publicized, many potential users could miss the reports linking it to liver and kidney problems. Especially because Alli is available over the counter — not under the care of a well-informed doctor — the FDA has a duty to protect the public by giving us the most complete information possible. If scientists show that orlistat causes kidney damage, the FDA would also have a duty to warn users — and, potentially, pull it from the market.


Based in St. Louis, Carey, Danis & Lowe represents clients around the United States who suffered a serious injury or illness from using a prescription or over-the-counter medication. Too many people assume that drugs wouldn’t be approved by the FDA if they weren’t safe. Unfortunately, that hasn’t been the case over the past few decades — prescription drugs have been shown to cause serious health problems or death, and even over-the-counter drugs have been restricted or recalled due to abuse potential and manufacturing defects. Our pharmaceutical liability attorneys help people who have suffered serious injuries sue the manufacturer for fair compensation for their medical bills, lost income and lost quality of life.
If your family has suffered an injury you believe was caused by a dangerous drug, don’t hesitate to call us to learn more about your rights and tell us about your case. For a free, confidential consultation, send us an email or call 1-877-678-3400 today.