Xenical and Alli Liver Damage Side Effects: FDA Early Communication

Harvey Kirk

By Harvey Kirk
Posted August 25, 2009


The FDA officially announced yesterday that they are reviewing reports that raise concerns that popular weight loss drugs containing orlistat, such as Xenical and Alli, may cause serious liver damage side effects. Although no definite association between reports of liver injury and orlistat have been established at this time, the FDA has identified this as an emerging safety issue.

>>FDA Link: Xenical and Alli Liver Injury Investigation

The product liability lawyers at Saiontz & Kirk, P.A. have been monitoring the potential for Xenical and Alli liver damage lawsuits since Scrips News reported that the FDA discussed orlistat’s potential link to hepatoxicity at an April 16 meeting of its Drug Safety Oversight Board (DSB). At that time, the FDA did not state how many post-marketing liver damage reports they were investigating, but more information was provided in an early communication issued August 24.

Xenical is a prescription medication that contains 120mg of orlistat, and Alli is an over-the-counter product that contains 60mg of orlistat. Both drugs are used to promote weight loss when taken together with a reduced calorie and low-fat diet.

According to the new information provided by the FDA:

  • Between 1999 and October 2008, 32 reports of serious liver injury have been submitted to the FDA’s Adverse Event Reporting System
  • 6 of the reports involved liver failure
  • 27 of the cases resulted in hospitalization
  • 30 of the 32 reports occurred outside the United States
  • The most commonly reported adverse events included jaundice (yellowing of the skin or whites of the eyes), weakness and abdominal pain
  • Other data on suspected cases of liver injury submitted by the manufacturers of olistate are also being reviewed

An early communication does not mean that there is a causal relationship between Alli and Xenical with the emerging liver damage reports. It also does not mean that the FDA is advising healthcare professionals or consumers to discontinue the products. In fact, the FDA indicated that the products should continue to be used as prescribed or directed at this time.

The FDA releases information like this based on current analysis of available data concerning potential Alli and Xenical side effects. The agency indicates that they will release additional findings concerning orlistat once their review is complete, which will also likely include any conclusions about whether the information warrants regulatory actions, like stronger warnings.


At this time, the lawyers at Saiontz & Kirk, P.A. are continuing to closely follow this investigation to determine whether users the orlistat drugs who suffered a serious or fatal liver injury may be entitled to compensation through an Alli lawsuit or Xenical lawsuit.

If you, a friend or family member have been diagnosed with liver failure, liver injury or hepatitis after taking Alli or Xenical, you can submit information to be reviewed as part of our evaluation of this potential litigation by requesting a free claim evaluation.

2 Comments • Add Your Comments

  • Jeni says:

    I took Alli for 2 years, with a very low fat diet. I am not overweight but wanted to maintain the 45 lbs I lost 3 years ago. I stopped taking it about a month ago, because I was having stomach pains. I am now going for an ultrasound of my gallbladder. If I do indeed have gallbladder disease, my guess is it’s in direct correlation to the Alli.

    Posted on August 31, 2011 at 5:12 pm

  • Ndiaye says:

    I started tikang Alli about two months ago to augment my diet and exercise program. I’m active, and with a BMI of 26, I just wanted to lose about 20 lbs that wasn’t coming off with my fairly intense cardio routine and low-fat diet. I would take Alli as directed with meals containing some fat but rarely more than the suggested amount of fat. And I did experience the treatment effects with meals within the suggested fat allotment: frequent, oily stools, random oily discharge (very gross), and stomach pain about 45 minutes after eating. However, they weren’t severe enough to make me stop tikang the med. Over time, I didn’t lose an ounce but kept tikang the pill as directed, hoping that it would kick in over time. It didn’t. And then I had a higher fat meal after tikang one Alli pill. I know that the`treatment effects’ are supposed to act like aversion therapy, but this was ridiculous. I ended up in the ER with crippling, stabbing stomach pain and dry-heaving. I had such a bad reaction that stomach pumping was treatment of choice. The ER doc suggested I throw the pills out as soon as I got home. After recovering from the ER ordeal and promptly pitching the bottle of Alli (the aversion therapy didn’t work to GlaxoSmithKline’s advantage this time), I did a little bit of research and found that I was not the only one with adverse reactions requiring medical care. This med has been linked to pancreatitis, gall stones, and possibly colon cancer (research was kind of spotty on this). Will everyone react this way to the drug? Of course not. Every med has side effects and not everyone can tolerate certain drugs. However, I hope that people will consider the risks and weigh the benefits before spending quite a bit of money on something that may not work. Overall, I ended up with nasty side effects, a considerable ER bill, and no weight loss. And for those it does work for, you may become dependent on the drug for continued weight loss or even weight maintenance (this is from the actual website)- quite a price to pay to lose 2 to 3 more pounds more than you would have with diet and exercise alone. If Alli works for you, awesome- more power to you. But before you buy, please read the fine print- the pill may cost you a lot more than you bargained for.

    Posted on March 30, 2012 at 12:46 am

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