Alli and Xenical Recall Petition Filed Over Risk of Kidney, Liver Problems

The consumer watchdog group Public Citizen has petitioned federal drug safety regulators to remove Xenical and Alli from the market, as the weight-loss drugs may cause damage to the kidney and liver. 

The Public Citizen Xenical and Alli recall petition (pdf) was sent to the FDA on April 14, arguing that the risk of side effects of orlistat, the active ingredient in Xenical and Alli, outweigh any potential weight loss benefits provided.

The petition came days after a study was published in the Archives of Internal Medicine which found that 2% of Xenical users were hospitalized for kidney problems once they started taking the drug.

Xenical (orlistat 120mg) is a prescription medication that was approved by the FDA in 1999. The lower dose Alli (orlistat 60mg) is an over-the-counter weight-loss drug that was approved in 2007. Both drugs are marketed by GlaxoSmithKline, PLC, though Xenical is manufactured by Roche.

Public Citizen says that a search of the FDA’s adverse event database links the medications to at least 47 cases of acute pancreatitis and 73 cases of kidney stones. The non-profit group also claims that studies have shown that neither drug is any more effective than diet and exercise.

“Any one of these serious risks alone would be sufficient basis for banning Xenical and Alli,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in a press release. “These drugs have the potential to cause significant damage to multiple critical organs, yet they provide meager benefits in reducing weight loss in obese and overweight patients.”

In May 2010, the FDA issued a drug safety communication about possible liver problems with Alli and Xenical, indicating that the agency had received at least 13 reports of severe liver injury among users. In two of the cases, the patient died, and three required liver transplants. All but one of the reports came from users of the prescription Xenical, not the lower-dose version that is sold over-the-counter as Alli.

Xenical and Alli are intended for use together with a reduced-calorie diet. They 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.

The Alli and Xenical recall petition is the second time Public Citizen has tried to have the orlistat-based drugs pulled from the market. In April 2006 the group called for a Xenical recall because of pre-cancerous lesions that formed on the colons of rats given the drug, but the FDA rejected the petition.

Tags: , , , , , , ,


  1. Erica Reply

    I took alli and a month later I ended up in the hospital for kidney stones. That was a year and a half ago and I have had 2 surgeries and I still have 2 stones.

  2. Christine Reply

    Well I been taking Alli since October 2010 and so far I have only lost weight

  3. Monique Reply

    Yea Im with Christine, I’ve been very successful with my wieght loss journey because Of Alli!

  4. Lindy Reply

    It would be interesting to know just how many pills Erica was taking. The bottle says never to take more than 3 a day and not to take if you are not consuming fat in your meal. I have used it off and on for more than 2 years and have not experienced any probelms that I am aware of?

  5. Zach Reply

    I’ve taken ALLI for several months with no problems other than the usual side effects. Like Lindy said, it would be interesting to know how many pills the people who are having liver problems & kidney stones were taking. It could be ALLI’s fault & they are just much more sensitive than the average person is. But I bet some of these cases have nothing to do with ALLI cuz many people that I know disregard the directions & take twice as much as they should of all kinds of over the counter medications cuz they think it will speed things up. Bad idea though cuz they are really risking liver damage or other side effects when they do that. I’ve also read that being obese in and of itself can cause liver damage. So I think it’s a lil too early to say whether this is all being caused by ALLI just yet.

  6. latishia Reply

    In 2008 I also was hosp. and diagn. with det. liver and it is due to xenical(Alli) I had been on xenical for over 3yrs and then started taking Alli when it hit the shelves up until Nov. 2008. I did not fall into the familiar categories for the condition and an gastro. spec. told me it was due to my using the drug for so long and that the studies only show up to 2yrs of useful data. I was dev. to say the least and now my amonia level stays in the high range and I have to take med. for my mental state due to my liver issues. I don’t deserve this.

  7. Julie Reply

    I also took Alli for a little over a month, only 3 pills a day, with fatty foods, I just passed a kidney stone (very painful) and just got back from the doctor, I may have more. Waiting for results. Never had kidney problems in my life.

  8. Debra Reply

    I’ve been taking alli for sometime now. Had a proceduredone. Before it was done, I had blood work done to check my kidney and liver. Everything was fine.

  9. Irene Reply

    Stop the nanny state. Allie works great for me and I have never had any problems. It controls my obesity which does cause problems. Tough luck for the idosyncratics.

  10. Karen Reply

    because of calcium intake I had problems with constipation. I started taking just 1 Alli capsule a day along with an over the counter stool softner a couple of years ago. For the first time in six years (exams every two years for polyps) I had a normal colonoscopy! I truly believe the combination of these two meds allow me to be regular and result in the clean bill of health exam.

  11. cc Reply

    i have had nothing but success with my alli i lost 50 pounds and much no other issues i was on it for 2 years and no side effects nor stones and my bloodwork for liver panel is fine i understand everyone is different but dont punish the public for the rare cases

  12. SHANTIA Reply


  13. sonia Reply

    I took ali for 4 months.I would tell anyone to not take this.For a year now i have had surgery to remove my gallbladder,I now have kiney stones,and gastrintitis.I now go to the doctor more than when i was over weight

  14. Ronda Reply

    I started loosing weight after having problems with zocor and crestor and other cholesterol meds making my joints freeze up, so I had to change my diet. I used Ali only when I knew I was eating something too fatty, so I would not absorbe the fat into my system. It helped me keep my weight down and i could still enjoy an unhealthy meal once in a while. i did however develop a severe kidney infection, but it was later determined to be e-coli causing it. I also developed a lack of Vit D, don’t know if that was related. I would use Ali again if it becomes available to control my weight

  15. Shauna Reply

    Those individuals who experienced kidney problems and stones likely had high cholesterol, etc. side effects of obesity…the very reason they were taking Orlistat.

    Cause and effect…not sde effect

  16. YVONNE Reply

    Hi – I took Alli for 3 months last year. dosage as instruced ,and careful with the fat intake(I always read all medical instructions carefully, and follow then slavishly as I hate taking medication). I did lose weight – around 8 kilos, and was very pleased. I stopped after 3 months, as I did not wish to risk any health issues. However, 3 weeks ago I was rushed into hospital with a badly inflammed gall bladder and gall stones after suffering sudden abdominal pains and severe vomitting. The doctor was astonished that the condition had arisen so suddenly, with no previous warning and after 5 days on an antibiotic drip to reduce inflammation, my gall bladder was succesfully removed. I have no family history of gall bladder problems, nor any previous history of it.

    So, is Alli to blame?????

  17. Vickie Reply

    I just got our of the hospital and am still being treated for severe diverticulitis….over half of my colon was affected, i have taken Alli for 3 months…. 2 or sometimes 3 pills a day untill i started hurting really bad in my stomach … then stopped taking them. P.S. i have never diverticulitis

  18. Christine Reply

    Pfft… Alli isn’t worth the health risks.

    It worked for me but has caused me nothing but worry,stress,hospital bills, and now failing kidneys. Before Alli, I was healthy no medical problems… now? If this kidney problem doesn’t clear up I’m looking at a year to 2 tops to live? Was it worth those 40+ pounds I lost? Nope!

    Do your research before taking these pills, or better yet why not try getting off your computer or couch, and go for a jog? Maybe throw away that junk food in your cabinets? Because Alli? It’s not worth it.

  19. wendy Reply

    I took alli for 6 months and was very successful until I got Kidney stones and needed a Lipotripsyon my right side! Very painful! The stone was larger than 1cm. I still have a couple of smaller stones on my left side. I passed one and have 2 left. Never had Kidney stones until I started taking ALLI!.

  20. cathy Reply

    I started taking Alli years ago! It never affected my organs. I lost weight and kept it off with Alli. I miss that it is off the market. I had previous a genetic heart condition(Afib) and had 3 surgeries on my heart. Alli never got in the way. I had a face lift and a tummy tuck, never any problems with liver or kidneys in my tests. The lady with Gall Stones, well she probably didn’t drink enough water to begin with. I know several people that NEVER took Alli, that have Gall Stones and Gall Bladder removed. Those conditions most likely aren’t linked to Alli.

  21. Patricia Reply

    I used Alli for one year. I was aware of side effects as stated on the bottle. In January of 2013 I was hospitalized for severe diverticulitis and a eight inch abscess on my colon and a UTI. I had never had diverticulitis before. I had surgery and they had to do extreme repair to my colon and bowels. My surgeon said on a scale of 1-10 with 10 being the worst my case was a 10. I have never been so sick or experienced so much pain in my life.They thought I would go into shock at any time. I was in the hospital for 24 days and had to go home on a wound vac of which I was on for about 5-6 weeks with home health nurses coming every 3 days to change it. Recovery has been very slow and now 7 months later I am starting to feel better. I have experienced extreme hair loss that started shortly after starting Alli in Jan. 2013 and I have read that others taking Alli have also experienced hair loss and UTI’s. I now have a hernia from the incision site of my surgery that has to be repaired. I see the surgeon on Sept. 16th. More pain and recovery. I haven’t known who to contact about this that’s why I have waited. I was so puzzled about how this all happened so suddenly and after I was home from the hospital for a few weeks I started thinking maybe it had something to do with Alli so I went on line and discovered many, many cases just like mine.

  22. Jacqueline Reply

    I took Xenical for 18 months and ended up on the Kidney Machine 3 day put a week took my kidneys out.

  • Share Your Comments

  • Have Your Comments Reviewed by a Lawyer

    Provide additional contact information if you want an attorney to review your comments and contact you about a potential case. This information will not be published.
  • NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

  • This field is for validation purposes and should be left unchanged.