Xenical and Alli Liver Damage Reports Reviewed by FDA

The FDA appears to be reviewing a possible connection between reports of liver damage and orlistat, which is a weight-loss drug contained in the prescription Xenical and the over-the-counter Alli.

According to a report by Scrips News, the FDA discussed orlistat’s potential link to hepatoxicity at an April 16 meeting of its Drug Safety Oversight Board (DSB), and the agency is continuing to review whether there is any connection between the drug and reports of liver damage.

The FDA is looking at both the prescription and non-prescription versions of the drug and said that any action taken would depend on the outcome of its analysis. The FDA would not state how many post-marketing liver damage reports it was investigating.

Orlistat is the active pharmaceutical ingredient in Roche’s Xenical, which was approved as a prescription medication in 1999. Last year, GlaxoSmithKline’s Alli, a lower dose version of the drug, was approved for over-the-counter use.

The medications are intended for use together with a reduced-calorie diet, and work by preventing the absorption of fats, thereby reducing caloric intake.

In 2008, Xenical generated sales of $30 million and Alli generated sales of $131 million during its first full year on the market.

Hepatoxicity is chemical damage to the liver, usually caused by drugs. The liver is the body’s main mechanism for metabolizing drugs, making it susceptible to chemical damage. Hepatoxicity can manifest in a variety of ways, including:

  • Necrosis of the liver, a form of hepatitis
  • Inflammation of the liver
  • Vascular lesions
  • Acute liver failure

Xenical’s labeling already lists liver injury as a potential side effect, stating that “exceptional cases of hepatitis that may be serious have been reported.” However, the label points out that that no direct relationship has been established between hepatitis and orlistat therapy.

Obesity itself is often linked to liver injury, and the fact that the FDA is reviewing adverse event reports associated with the use of Xenical and Alli does not mean that there is any cause and effect relationship.

The primary known side effects of Xenical and Alli include oily and loose stools, fecal incontinence, frequent or urgent bowel movements and flatulence, which tend to be most severe when the treatment is started and may decrease with time.

The FDA put orlistat on a list of drugs linked to new safety risks earlier this year after examining reports of Xenical’s possible links to rectal bleeding, however the agency determined that no action was needed.

It has also been suggested that Orlistat side effects may increase the risk of colon cancer and breast cancer, leading the consumer advocacy group Public Citizen to call for an Xenical recall in 2006.

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  1. Rebecca Reply

    I took Alli for several months. Started having extreme pain in liver and gallbladder area. Doctors took test after test, charged me lots of money. I asked both doctors if they thought it could be the Alli. Both said no way. I stopped taking and low and behold pain ended. A year later gallbladder got so bad, no gallstones) that I had to have it removed.

  2. ellen Reply

    I took Alli for 4 months and I had always been healthy. Became very tired with discomfort on left side. CT scan showed a large aggressive tumor omy right kidney, I truly believe Alli was to blame.

  3. Mary Reply

    When I first took Ali (3 yrs ago, on & off) I had no problems and lost 15 lbs within 3 weeks. Stopped because I had achieved my so called ideal weight. Few years later, I now have thyroid problems, diverticulosis and pain on my right side under rib cage. Now I’m wondering if it’s because of the Ali. 🙁

  4. mark Reply

    was taking xenical prescribed by a doctor between 2009-2010 in 2012 i had to have my gall bladder removed im convinced it was due to taking xenical who do we report this too this drug needs to be stopped

  5. Claire Reply

    I\’ve been taking Zenical on and off for the last 2 years. I have just come out of hospital after being diagnosed with diverticulitis, I am otherwise a healthy person with a normal diet. I am also convinced that Zenical is to blame……. so what do we do?

  6. Marilyn Reply

    I took prescription Xenical off and on between 2002-2003. After having carpal tunnel surgery in 2003, my surgeon told me I was sick and needed to go see my primary care physician. My doc sent me to the gastroenterologist who performed a colonoscopy. Long story short…I had surgery for stage IIIC colon cancer on Dec. 31, 2003. Prior to going into the OR, the surgeon told me that CAT scans looked like the cancer had metastacised to my liver. Luckily, the spots on my liver were not malignant. I also have diverticulosis. I went through weekly chemotherapy from Jan. 2004 – Sept. 2004. 5 days after my last chemo treatment, I went to the ER with pulmonary emboli in both lungs. I had a crainiotomy for a subdural hematoma in 2005. I remain on oxygen 24/7 today. It never occurred to me that the Xenical could be linked to my colon cancer. Now I wonder, as there is no cancer in my immediate family even though my parents were both smokers.

  7. Erin Reply

    I took Alli back in 2007. I was trying to lose only 10lbs, was very healthy beforehand. Never had any prior health problems. I took Alli for about 2 weeks and stopped due to the horrible bathroom issues it csused. Within a month after ending Alli I started having severe abdominal pain and suffering from significant weight loss and diarrhea any time I ate. I was in the emergency room 3 times a week. They did every test imaginable but couldn\\\\\\\’t find anything wrong with me. After a year and a half of horrible pain and losing 80lbs without trying, they removed my gall bladder. Unfortunately that didn\\\\\\\’t help…I was sent to to Dartmouth hospital and they found I have Chronic Pancreatitis. I have been sick since I took Alli. I never drank or did drugs. I had a great government job and now I\\\\\\\’m disabled and waiting to have my pancreas removed. I am 31 years old and have two young children. ..This drug needs to be banned!! It literally ruined my life!!

  8. William Reply


  9. Juliana Reply

    I took Alli for only a week. Last Sunday I noticed that my stools were white and Monday I woke up with pain on my right side, not huge pain, but there all the time. My stools are still white, the pain here, very gassy… I am scared, really! My doctor’s appointment is tomorrow at 11:00 am and I hope I am not seriously ill. By the way, I am not obese, 10 pounds overweight only.

  10. Lori Reply

    I weighed 267 in march 2014 began taking Alli,I went from 267 to 224 in 5 mnths,I have many bowel movements a day,take a multi vitamin as well I haven’t had any corporal body fat went down and I gained muscle.(only exercise 3x a week)

  11. Rebecca 2 Reply

    I have been taking first xenical, and then Alli, on and off for about ten years. It worked fine art first. Lost thirty. Stopped taking it for a couple of years, but Then after I had my daughter, I started again ( Alli this time). It didn’t work quite as well, but still helped. Then right before the first recall, a new bottle of medicine I had didn’t work at all. Someone said that the Indian lab that produced the actual drug, didn’t put any active ingredient in for awhile. I tried again a few months after it came back on the shelves (right before the second recall, which was hinkey as heck btw). I took all 120 over a couple of months, and low and behold (just like everyone else on here).. pain in upper right under ribs, and right side of abdomen like a stitch from running. Spread into back too, as well as causing constant acid reflux, which has started hurting my esophagus. Now the doctor says my gallbladder has to come out. I never had problems before the first recall, so I wonder if they knew something was wrong with it, and just tried to cover it up.

    Just read a study on the effects of Alli/Orlistat on the gallbladder.. The doctors found that the medicine doesn’t allow the gallbladder to empty. It decreases it’s effectiveness by 85%… so that it can’t break down the fats… so that they will pass without absorption. The old bile sits in the gallbladder, and creates stones and/or inflammation and infection. Wonder why THAT isn’t brought up? The company has acted totally squirreley every time the product has been “tapered with”… yet they don’t own up to any of these very prevalent problems.

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