Xenical and Alli Liver Damage Reports Reviewed by FDA
Published: May 27th, 2009 • Comments: 41
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.
Comment by JANET on 28 May 2009:
ok i have had both kidney damage and liver damage since i used alli. i was perfectly healthy before what steps do i take
Comment by Chandra on 6 June 2009:
I developed Rhabdomyoysis when I was taking Alli, hospitalized in ICU for 3 days.
Comment by Charlotte on 17 June 2009:
I developed diabetes while taking Alli and high blood pressure
Comment by Katie on 18 June 2009:
I just went through a host of tests because I have possible liver damage/ tumors. I hope for the best, but the only culprit would have to be the Alli (and Xenical before that) I have been taking on and off for five years. I am otherwise healthy and not even that chubby- I wish I had opted for good ol’ fashioned moderation.
Comment by Kim on 3 July 2009:
I have been taking Alli for over a year and I have Graves and high blood pressure. I am checked twice a year and just had it done 3 weeks ago and my liver was good. Matter of fact everything came back better than it has been in a long time.
Comment by Chris on 3 August 2009:
I am 39 and took Alli for 18 months. In January, 2009 I became very sick and after a colonoscopy I was informed I have a confirmed, unusually advanced case of diverticular disease. As of the past 30 days I also have unusually dark, tea-colored urine and will be getting liver testing done as well.
DO NOT TAKE THIS DRUG
Comment by Joe on 24 August 2009:
Oh MY God . I have performed various lipid tests trying to find out why my liver is 20% larger than normal. My doctor was insisting that I drink too much even after I told I do not drink. When I told him it might be Alli he said that he doubts that very much and anyhow the benefits outweigh the risks. After reading this report and hearing it on the news I will get my liver test again by a different doctor. There has to be some sort of recourse.
DO NOT TAKE THIS DRUG AT ALL
Comment by Liz on 24 August 2009:
I am 29 and just had surgery on my colon. They found a tumor a week ago on the right side of my colon. They found out I have diverticulosis/diverticulitis. I have been on alli for almost 2 years. I lost the weight but have been on it to keep the weight off. But, now I have this disease. Now I have to go for a colonoscopy in Dec to check up on the status. The doctors are stumped as to why I got diverticulitis at such a young age.
So I have the same condition as the other person (Chris) who just commented above. She was on alli for about as long as I have.
Comment by Lynn on 24 August 2009:
I took Xenical on & off for about 2 years and I have also taken Alli on & off since it became available over-the-counter. In the last 2 years, I have had kidney problems and have noticed a change in the way I feel. Not sure how kidney damage could be related to Xenical & Alli, but I am going to call my PCP tomorrow and schedule an appointment to have liver function tests, kidney tests, and other tests done. My urine has also been tea-colored at times and blood has shown up in my urine samples also on several lab tests, but my PCP does not know why. I will post again when I find out something new to add. Thanks much.
Comment by Bill on 25 August 2009:
Both my wife and myself have been on this Alli for at least one year possibly two. We didn’t know about the drug that was prescribed. Does this mean that if you have taken just Alli that all these things described may possibly happen?
Comment by Kimberly on 25 August 2009:
I use to take Xenical & hve been taking Alli for 2 years now in the last few days my stomach has felt very Upset and I have been constipated just took it yesterday and heard about the recall today. can anyone tell me if upset stomach and Constipation are related to possible Liver Damge? Thank you Kimberly
Comment by Tina on 25 August 2009:
I took most of ONE bottle of Alli in late summer 2008. Could not stand the side effects I was having, so I stopped. In May 2009, I started having pain in my gallbladder/liver area. I had my gallbladder removed due to sludge and am still having the pain. Starting to feel like Alli had something to do with this….
Comment by Kim on 25 August 2009:
I have been taking Alli for 8 months off and on. It has saved my life I have lost 65 pounds and I am more healthy now than before. Everything you take can have side effects you cant blame Alli for all the problems in your health.
Comment by BeTony on 26 August 2009:
I’ve been using alli for exactly 1 bottle, which I just finised, helped me lose 10pounds; now that I read this, even if it’s unconfirmed I can tell you I won’t go through, I’ll stop immediately.
Atm, I still seem healthy, don’t have any symphtom
Comment by Cara on 27 August 2009:
I took Alli for four months and got the worse UTI ever I wasn’t drinking alcohol or soda I even tested myself after the UTI and started Alli again I went right back to having the same symtoms. I dont know if this is related but I was diagnosed with diabetes about a yr after taking Alli…
Comment by Valerie on 31 August 2009:
I took Alli for two weeks and developed a terrible UTI that put me in the hospital, I stopped taking Alli to take my antibiotics and was going to start again, but now im scared!
Comment by Christine (Mesa, Az) on 31 August 2009:
I have been taking ALLI over the past year. I just had blood work done and my doctor had to take a double check to make sure it was actually my blood work. My bad cholesterol went from 260 down to 198 and my good cholesterol went from 137 up to 171. My doctor asked what I had done different over the past year (between my two blood tests) and I told her I did the ALLI program — that truly was the only thing I had done different over the past year.
Comment by Vanessa on 1 September 2009:
I took Alli for about a week before my left side developed a pain and within 3 days became so bad i could hardly walk, breathe, and sneezing was torture. I went to the Doctor, in fear i had an infection of some sort. He gave me a physical, a pelvic exam, and both blood and urine tests. Next he wanted to give me a CT scan thinking i have damage to my kidneys or liver or possibly a kidney stone. In the end I stopped taking Alli,(nothing in my lifestyle had changed besides alli) my side stopped hurting and all my symptoms disappeared. Needless to say my doctor bill was sky high, and the Alli was tossed.
Comment by Ronnie on 3 September 2009:
I have taken ALLI for almost a year and lost over 60 lbs. No adverse side effects and in great health.
Comment by will on 11 September 2009:
Listen fat people you would have probably goten the illness anyway, stop scaring people. I took it for six months and feel great! no problems, help me make my goal. stop whinning and go for a jog…
Comment by corie on 15 September 2009:
i’m a little frustrated with several of these posts. I’m assuming that you are taking alli because you are overweight. Are you aware that being overweight greatly increases your risk of developing diabetes and high blood pressure? And yes I know, you were “healthy” before taking alli, but in all reality, everyone is “healthy” before they are diagnosed with diabetes or high blood pressure. As for diverticulosis, it’s thought to be caused, at least in part, by diets high in processed foods and low in fiber…that diet should sound pretty familiar to most of you…we do live in America. And yes, it generally is seen in older adults, but so was type 2 diabetes as of 10 years ago, but as you all know thousands of children and teenagers are now suffering from it due to poor diet and a sedentary lifestyle. Does Alli contribute to liver damage or diverticulosis?? I have no Idea, but please stop with the “I have a problem so I need to find something to blame it on” attitude.
Comment by Dee on 15 September 2009:
I’ve been taking Xenical, and now Alli, regularly for about 5 years along with moderate exercise and a decent diet. (Im 56) My weight loss has settled in at about a 25lbs, my blood pressure and cholesterol have both significantly improved. All this while going through menopause. Prior to using Xenical I had regular lab test show up with “high liver enzymes” and that hasn’t gotten better or worse. Genetically I have a tendency to put on fat in my upper body and Xenical/Alli have been a tremendous tool for helping me control the fat gain.
Comment by Debra on 21 September 2009:
I have taken Xenical since it was put on the market, now I just take the Alli because I dont have to get a prescription. I started this medicine years ago! I learned to live with the side effects by eating low fat foods like you are supposed to do. I am an RN of 30 years. I just had a colonoscopy, I have NO diverticulosis. My liver enzyme tests are and always have been normal. I know overweight people, as a rule, have a greater tendency to develop diverticulosis from eating a poor diet, high in carbs and sugar and low in fiber. Also some overweight folks do drink and are possibly also chronic pain patients, who take lots of pain meds which frequently cause liver damage. I am a chronic pain patients myself from a back injury 15 years ago and several failed surgeries. I cant do much excercise because of this. I use the alli, and the diet that comes with it,to keep my weight down. Someone can always connect any medication with any symptoms, or condition,but that doesnt mean that medicine caused it. I know people are sick all over the world and want to find the causes, but FDA should investigate all the other causes for these condidtions in these patients before they say that Alli is causing it. If you take the fat soluble vitamins, A,D,E,and K, that you dont aborb properly on this med, you should be fine. I hope this doesnt turn out to be another bogus lawsuit! We have too may already! Read the side effects of the minor meds you take everyday! You could be too scared to take anything! Alli has worked for me and has not hurt me. I dont drink, take drugs, or have any other serious medical conditions, I believe these cases alledging the alli causing the conditions,are connected with other conditions more than being caused by the drug Alli! Alli is a great med if properly used! If someone is a drinker, wont take vitamins,or has serious medical conditions, then they shouldnt take anything without the advice of the doc!
Comment by LeY on 22 September 2009:
i have no bad side effects since i started using alli except for the oil that drip in the @ss. Good side-effect: sexy body that I never imagine i could have. I couldn’t have done this without alli. I do workout but alli boost it up. all i can say is that every person is different ok? if one thing doesn’t work, then stop. as for me, i will continue alli.. goodluck!
Comment by M on 29 September 2009:
I had a scheduled c-section in July. Prior to my surgery I had a full blood panel done, and everything was perfect. After having my son, I wanted to try Alli along with diet and exercise, to help boost losing a few extra pounds before I returned to work.
I have only been taking Alli for 3 weeks. I went to the doctor the other day for bloodwork, just to check out my post-surgery health. She called me this morning to tell me that my liver came back abnormal and my thyroid levels are a mess.
My liver and thyroid were perfect only 11 weeks ago. Now after 3 weeks of using Alli, I’m having these issues. I’m stopping the pills immediately.
Comment by Barbi on 13 October 2009:
Ok, so as for M, childbirth is a known culprit for thyroid and liver issues. As for all the diabetes and high blood pressure folks, you were obese before you took the alli, and that is what caused the DM and high blood pressure. as for the diverticulitis, you got that from low fiber, crap food. The drug just simply doesn’t effect the mechanisms that you are describing. I am frustrated when people hear a link, and take it for fact. For example, if I had a vaccination at 10 am, then walked outside my doctors office and got hit by a bus, it is not the vaccines fault, but some would say, well she got the shot just before! Think people, research is done on these drugs and it is exhaustive, and I trust doctors and the FDA in general, and a lot more good has come out of the ALli program than bad. Stop eating so much, get off the couch,. and cut the fat. use alli to help and reduce portion size, you willbe on your way to a happier healtier you. and, if by chance you have other health problems, look to yourown genetics and health habits first.
good luck! I lost 65 lbs, stopped taking it, and stopped exercising and went back to eating bad, and BAM the pounds came back. I am back to the gym EVERYDAY, eating good, and taking alli, wish me luck! as a side note, I did have awful side pain that was unexplained while on the ALLI, so that, as I see, was another compalint, maybe there is something to that. I started taking it again and the side pain came back, and no, its not gas.
Comment by Peg on 18 October 2009:
I have been taking alli ever since it came out (4 years?) and have lost the weight I fought for 62 years. about 35 pounds. I am 76 and in great health, but I will have liver tests next physician appointment.
Comment by Joey on 24 October 2009:
My colon ruptured after taking Alli for a little more than a month. I had no prior symptoms other than gerd. I had to wear a bag for 6 months.
Comment by sany on 29 October 2009:
i had liver problem befor,,im 0ok now,, iwant to take xenical i dont know if its 0ok or not ,,, ;(
Comment by R on 28 November 2009:
I would not take this stuff if you paid me. I am moderately overweight and I considered taking some diet drugs but this has deterred me. People if you are mobile you can lose the weight on your own! Healthy moderate eating and exercise never killed anyone but apparently these drugs can. Stay safe, you only have 1 life to life. What good is it losing weight if you end up with major organ failure as a result? God bless everyone who has suffered complications
Comment by Courtney on 2 December 2009:
This is all scaring me. I love ALLI !! It has helped me lose 21 lbs. and I am so happy and thankful. I have also been on a diet with it but Alli definitely helped. I am a type 1 diabetic and no it was not caused from me being over weight because I only needed to lose 20 lbs. after giving birth to my daughter. I was never obese. I haven’t had any health issues I could attribute to Alli other than headaches once in a while but I also don’t want to wake up one day with liver failure. I do not want to stop taking alli but maybe I should get my liver levels checked just to be safe. I feel that the FDA would not put this on the market nor would they keep it on the market if they seriously thought it caused liver damage because ultimately without liver function a person cannot live. I will look into this further but as for now I think I will continue to use alli because it has helped not only get to my goal but to maintain it.
Comment by kATHARYN on 14 December 2009:
i took xenical on and off for a couple of years after a sporting injury and couldnt excersice. i was perfectly healthy but then developed liver damage digestive problems, painfull ligaments, nerve damage, fibramyalgia pain all down my right side and fianlly breast cancer in my right breast. highy dangerous and toxic drug. deplete essential fatty acids and omega 3 oils essential for life and immune and cellularlar protection and xenical promotes accute inflamation in the body a precursor for all disease…please stop these drug companies from killing us for the sake of immoral profits.
Comment by Elizabeth on 21 December 2009:
I wanted a quick fix….I was 5′9″ and 160 lbs…not that bad really…..so I took it…got down to a very sexy 138 lbs w/out really trying…just took the pills. I looked great, had no fat on my body and felt the best I had in my entire life! Then it started. My hair fell out, started vomiting every morning and woke up with severe headaches. I stopped taking the Alli after 9 months. That was one year ago. Now, I don’t hardly eat anything and weight a whopping fat 180….WAY more than I ever used to. I am sick as a dog. My Doctor suspects colon cancer and am undergoing several tests right now. I don’t care how these people post about how FAT we must have been to take it and these diseases are caused by our being FAT before. I wasn’t really fat before….now I could be dying. At least I feel like I am. My liver enzymes are off the scale, my stomach is so swollen from ascites and I am an absolute shell of who I was last year. If I only knew then what I do now, I would have rather been 10-15 lbs overweight than feeling like I am dying and be 35 lbs. overweight.
Comment by Paska on 1 January 2010:
Doesn’t it make sense that Alli or any drug that dramatically alters how the liver is to perform its work will create some problem. There are no quick fixes even though we – myself included – are part of the drive through generation where we want everything FAST. The fact is that we must all start with first taking in the right foods that are NOT processed with additives, perservatives, high in sodium, color dyes, artificial stuff. We must also think in terms of cleansing our body of the toxins. The LIVER simply wraps all this bad stuff with fat cells — think of it that way and you will not want to put bad stuff in your body.
Comment by Candice on 16 January 2010:
Alli caused massive hair loss. Alli caused me to lose 1/2 my hair.
I have never had any type of hair loss, since taking Alli I have lost half my hair. also Alli caused severe, severe, dry hair and skin and Alli made me very tired. THERE ARE MANY NEGATIVE ALLI REPORTS ON THE OFFICIAL ALLI WEBSITE (POSTED BY ACTUAL ALLI USERS IN THE ALLI FORUMS, BUT THE POSTS ARE REMOVED AS SOON AS THEY GO UP)
…..Vitamins don’t do enough . In my opinion Alli will be changed or taken off the marked due to liver damage, stomach cancer and massive hair loss…..
Houston Texas
Former Alli user
Comment by Theresa on 5 February 2010:
I agree with all those who said the Alli pill did NOT effect them at all! I have been taking the Alli pill for one year and have NO liver problems. I started taking it for the same reason everyone else has, cause I am over weight!!! Educate yourself on better eating habbits, take walks EVERYDAY!!! If you are still eating high fat foods and are having problems with your liver or colon, then rethink what you putting in your mouth. And no, the Alli pill has nothing to do with you enlarged liver. It’s all that fat food you are still eating. Of course vitamins don’t do enough Candice, you need to eat a HEALTHY diet. Has anyone ever taken a class on nutrition? If the fat american public would read a little, maybe we wouldn’t have so much to complaine about or people to point the finger at, other then ourselves!! I use to be 200 lbs and now I am 126. I educated myself on a healthy lifestyle and made exercising a part of mt daily life.
Comment by Lauren on 15 February 2010:
I took My Alli, as prescribed on the bottle. While my liver panels are normal, within 4 months of taking My Alli in decreased dosage, I contracted severe diverticulitis. When I contacted the pharmaceutical company and spoke to a nurse, I asked if the sstomach pain warning on the bottle was specific to any disorders or if this was a common side effect. She said no, they just put that warning on the bottles “just in case” and she would document that I called just to track calls on the product. I was on a course of antibiotics that cost over $300 b/c of this episode. I never had GI problems before taking My Alli. I see a direct correlation between my diverticulitis and this prodcut. This product should not be available over the counter!
Comment by Heidi on 18 February 2010:
After 1 week of useing alli I developed pain on my right under my ribs and pure white stool. scared me to death and as soon as i stopped taking alli my body went back to normal
Comment by Danielle on 7 March 2010:
I’ve always been about 20 pounds overweight, seeing all the fabulous-
Alli commercials made me confident that this product would work!
I used it for about 1 1/2 years, first started taking it to drop 12-15 pds so I could have Smart Lipo.
It worked I lost 12 pds. I continued taking it as a crutch, I work retail (long hours) never have alot of time for exercise and thought it woudl do the trick.
It kept my weight down, until about the time I stopped taking it I was fine then I started having major problems with constipation.
I stopped taking it and 8 months later I am still waking up at 4 am with severe stomache and lower back ache/pain, the worst pain I’ve ever endured.
I’m miserable, my body feels old and I am only 38, most of the time I’m exhausted and feeling crappy. The only thing that gets me through the pain at 4 am is a half a vicodin.
It’s tappered off but it still comes on and I end up in a fetus position on the floor or the couch.
I admit, I could focus on my workout a bit more, my fault.
However, when you spend money for a treatment, the last thing you think will happen is major pain.
Diet pills are no joke! They will ruin your life and eventually create problems of which were not there prior to taking the medication.
Do yourself a favor, eat healthy, workout and be happy with yourself. Or go to a doctor and figure out an alternative than Alli- it will ruin your life!
Good Luck,
Danielle
Comment by Nancy on 8 March 2010:
Wow. I’m 5′7″ and 143lbs. I’m by no means fat but wanted to lose just a few pounds. I just read the last comment and realized I will no longer be taking Alli. My last couple stools have been clay/white in color. When I looked up possible causes it said bile obstruction or liver disease. I’m hope I’m not too late and my normal balance kicks back in. FYI I exercise regularly and I eat healthy. I’m only 30. I have no prior GI issues not even GERD. Never had heartburn once. It will be sad if this has caused permanent damage. I am an RN so I consider myself somewhat aware of looking for possible side effects. It seemed so safe.
Comment by katryn on 14 March 2010:
I started taking Alli January 1st as part of my New Year’s resolution. I’m very happy that I’ve lost 26 pounds so far even though I wasn’t too overweight to begin with. But today I had to go to the hospital and I found out that my gallbladder was full of stones and now has to be removed. I’m just wandering if me taking the drug played a part in it.