GlaxoSmithKline PLC has released a statement in support of their orlistat-based weight-loss drug Alli, following the FDA’s announcement Monday that they are investigating reports of liver damage that may be linked to Alli and Xenical.
Alli (orlistat 60mg) is an over-the-counter product that was approved by the FDA in 2007 to help promote weight loss when used together with a low-calorie, low-fat diet. During its first full year on the market in the United States, Alli generated $131 million in sales for GlaxoSmithKline and has been viewed as a very important product for phamaceutical company.
On August 24, the FDA issued an Early Communication to notify the public that they are reviewing a potential liver damage risk with Alli and Xenical, a prescription version of the weight loss drug that contains 120 mg of orlistat. The FDA has received 32 reports of liver injury among users of orlistat weight loss drugs, including 27 cases that resulted in hospitalization and six that involved liver failure. The most common symptoms reported were jaundice, weakness or fatigue and stomach pain.
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Learn MoreIn a press release issued on August 25, GlaxoSmithKline refuted the potential Alli liver damage risk, pointing out that orlistat has been well-studied and no evidence has been found to indicate that it causes liver damage. The drug maker also pointed out that there can be many causes of liver damage, and people who are overweight and obese are predisposed to such disorders.
“alli is a ‘non-systemically’ acting medicine – it is minimally absorbed in the blood and works locally in the gastro-intestinal tract,” said GlaxoSmithKline in the statement responding to the FDA’s Early Communication. “There is therefore no obvious biological mechanism to suggest liver damage can occur with alli.”
An Early Communication by the FDA does not mean that any conclusions have been made that there is a causal relationship between Alli and liver damage. The communication is designed to keep the public informed of ongoing safety reviews involving drugs, and the agency indicated that they will communicate their findings as soon as the review of orlistat liver side effects is complete.
At this time, the FDA has urged consumers to report any Xenical or Alli side effects to their MedWatch Adverse Event Reporting program and to contact their doctors if they are experiencing symptoms possibly associated with the development of liver damage.
The FDA indicates that consumers currently taking Alli should continue to use the product as directed, and users of Xenical have been advised keep taking the drug as prescribed, pending any final conclusions.
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16 Comments
JanieMarch 23, 2011 at 1:02 am
My cousin Brenda and I starting using ALLI 2 years ago and at first it was a easy way to loss weight. After a year and half the weakness began and we both took to bed. Last week Brenda was told she has liver cancer stage 4. Brenda's blood test did not show the liver had a problem until she was opened up. As for my self iI am very sick and I have lost all of my energy, the doctors have said I have[Show More]My cousin Brenda and I starting using ALLI 2 years ago and at first it was a easy way to loss weight. After a year and half the weakness began and we both took to bed. Last week Brenda was told she has liver cancer stage 4. Brenda's blood test did not show the liver had a problem until she was opened up. As for my self iI am very sick and I have lost all of my energy, the doctors have said I have severe thyroid disease and graves disease . They are tesing me for liver probllems also now. BE CAREFUL TAKING ALLI IT WILL TAKE ALL OF YOUR FAT AND DRAIN YOU OF YOUR ENERGY.
MarciaFebruary 27, 2011 at 4:15 am
Update: Found out that I have Gallstones. I never had issues like that in the past, but now after taking Alli I may be facing surgery to have my gallbladder removed. GSK is using us a guinea pigs.
MarciaFebruary 23, 2011 at 7:21 pm
I am really mad when I read the other posts stating that they believe the people had liver issues prior to taking the drug. The FDA has only had 32 reports of liver injury...this does not include those people who have liver injury, but don't have severe symptoms as those who were hospitalized and had liver failure! The statements that you are making in your comments about the 32 people with live[Show More]I am really mad when I read the other posts stating that they believe the people had liver issues prior to taking the drug. The FDA has only had 32 reports of liver injury...this does not include those people who have liver injury, but don't have severe symptoms as those who were hospitalized and had liver failure! The statements that you are making in your comments about the 32 people with liver injury are ignorant and heartless! Think about what you write before you post it! Don't blame the people who got sick from this drug because GSK says there is no possible way it can cause liver damage. It clearly can and does! Stop being rude and ignorant morons! "The FDA has received 32 reports of liver injury among users of orlistat weight loss drugs, including 27 cases that resulted in hospitalization and six that involved liver failure. The most common symptoms reported were jaundice, weakness or fatigue and stomach pain."
MarciaFebruary 23, 2011 at 7:12 pm
I've taken this pill for a little over a month and I had the "treatment" effects, but seriously when you start having bloody bowel movements and pain in your liver and abdomen you will wonder why the only effects GSK focuses on is the oily in your bowel movements. That is the least of your worries! This drug is not worth it. I did NOT have liver issues before taking this drug. I am 32 years ol[Show More]I've taken this pill for a little over a month and I had the "treatment" effects, but seriously when you start having bloody bowel movements and pain in your liver and abdomen you will wonder why the only effects GSK focuses on is the oily in your bowel movements. That is the least of your worries! This drug is not worth it. I did NOT have liver issues before taking this drug. I am 32 years old and 180lbs. Not really huge, but I do have weight to lose. I didn't lose anything with the help of this drug, other than my health! I've stopped taking the drug and am now being evaluated by my doctor to determine why I am having bloody bowel movements that are getting worse despite the fact that I am no longer taking the pills. We are also trying to determine the cause of my liver pain. It is not worth your health to take a drug that only blocks 1/4 of the fat you eat.
StephanieFebruary 18, 2011 at 7:40 am
I have been taking Alli for over one year. I do not care about the "oil" that leaks out. I was concerned about how ill I had become. It seemed as though it was out of the blue that the fatigue, listlessness,diarrhea,and much more occurred. I was surprised because this had never happened before two months ago! It is also interesting because I am writing a refutation essay about diet pills and the[Show More]I have been taking Alli for over one year. I do not care about the "oil" that leaks out. I was concerned about how ill I had become. It seemed as though it was out of the blue that the fatigue, listlessness,diarrhea,and much more occurred. I was surprised because this had never happened before two months ago! It is also interesting because I am writing a refutation essay about diet pills and the dangers they represent. Even though I took a vitamin every evening, I still felt horrible. I have lost 30 pounds in 2 years. I do not think this diet pill is safe for anyone! I am going to begin Weight Watchers. This I know is very healthy and it is proven that weight loss is fast and safe!
dimegirlOctober 14, 2010 at 12:38 am
YES,I take Alli as needed. I would never take Alli on a daily basis.All Alli does is allow your body NOT to absorb all the fat that you eat.Its side effects really FORCE you to pay attention to everything you do and eat.If i want to eat something i make sure& check that it is in the 15-18% fat content range,I also pay attention to my portion sizes and stop eating as soon as i feel full. I hav[Show More]YES,I take Alli as needed. I would never take Alli on a daily basis.All Alli does is allow your body NOT to absorb all the fat that you eat.Its side effects really FORCE you to pay attention to everything you do and eat.If i want to eat something i make sure& check that it is in the 15-18% fat content range,I also pay attention to my portion sizes and stop eating as soon as i feel full. I have a system and this is how it goes. I keep Alli on hand if i know that i am going to eat a more fattening meal then usual.If i plan to eat a half a pint of ice cream or go with my daughter to eat out i have them in my purse,this way i know quite a bit of this mainly unhealthy fat is on its way out!.I do not take the pills when i eat a salad or my daily Avocado,most all healthy meals that i eat i will not use the pill.I want my body to absorbed the healthy good fats.I think taking this pill 3 times a day could be taxing on your liver-its just using the drug to much in my opinion. When i do finally run out of the diet pills i purposely wait about a month to buy some more and get it out of my system... The Alli budget: Alli is not cheap,and it rarely goes on sale,but you can get it cheaper if you know what to look for. I have a ALLI BUDGET of $35.00-$40.00 total for 120 Alli diet pills. If you check the internet for store sales,Amazon on especially EBAY you can almost always get a 120 bottle for $39.99,and that is the going rate for 60 pills at the store. When ever I see the price i want to spend only then do i buy.Sometimes i have to wait more then a month and that is ok for my health and my pocket book. Other things i do to lose weight is cut out ALL foods and processed products that contain HIGH FRUCTOSE CORN SYRUP or HYDROGENATED OILS.These ingredients are altered by man and do not allow your body to feel full so you do eat more.If you are going to eat something sweet MAKE sure it contains real sugar so your body CAN tell you "stop eating i am full" If you have a treadmill before you decide to run/walk,buy a waist wrap- tighten it as tight as you can around your waist and run in front of the TV! 1-30 min. show later you have now ran over a mile:) You will also notice lots more sweat around your waist from wrap.My waist can't live without it! Its the corset concept,you have seen women on tv and the internet with the small waist lines due to wearing a corset.Take measurements of your waist line before you start wearing it for a couple hours a day.Then check your waistline a month later and you will see it works quite well...good luck to all!
AshleyAugust 28, 2010 at 8:16 am
I took alli 3months along with diet and exercise. I did not lose a pound my bowels had oil spots. I also broke out with a severe rash which covered my entire body. When I discontinued the use of Alli the rash cleared up with the help of Calamine lotion. I would not recommend this product to my enemy.
ConnieJune 9, 2010 at 2:03 pm
I have been taking Alli since January, approximately 1 to 2 pills per day. Only when I eat a meal with some fat in it. I have lost 40 pounds. I follow a low fat diet and exercise 5 days per week. The only time I have " Treatment effects" is when I have high fat foods. I have never had any uncontrolable effects. And no other side effects. I have been trying to lose weight for years and I have final[Show More]I have been taking Alli since January, approximately 1 to 2 pills per day. Only when I eat a meal with some fat in it. I have lost 40 pounds. I follow a low fat diet and exercise 5 days per week. The only time I have " Treatment effects" is when I have high fat foods. I have never had any uncontrolable effects. And no other side effects. I have been trying to lose weight for years and I have finally gotten good results!
ScottJune 4, 2010 at 5:52 am
I have been taking Alli for 4 months, and dropped about 10 pound in the 2 month period prior. Since taking, I have dropped 40 lbs in 4 months. I am also working out 2-4 times a week. I think that Alli, when used in the recommended dose is a good option for us. I went from 270 to 219 today. good luck everyone....
maggieJune 1, 2010 at 4:57 am
I read others had the same symptom I did...when I was taking 1 per day no problem...then as directed 3 per day my poo turned WHITE, I stopped and it immediately went to normal again. I didn't realize the significance of this at the time, it means that bile has been shut down. I read other bloggers who'd had the same symptom which is very serious. I aint touching the stuff ever again.
tinaMay 28, 2010 at 6:22 pm
I took alli and it did nothing for me. made me poop orange, i saw no results. I did what i was supposed to with the diet and it showed nothing.very unhappy. i would not recommend it to anyone.
lisaJanuary 8, 2010 at 5:12 pm
I just started taking it and the only treatment effect I had was the first day (because of what I ate the day before). Watch your fat/cal intake, hydrate, eat fruits and veggies, you should be fine. I agree the bad side affects are people not watching what they eat and the 32 probably had liver isses before starting the program.
PennyOctober 16, 2009 at 3:41 pm
Hmmm, I've taken Alli for 6 months and went from 87kg to 76kg with exercise and pretty healthy eating plan. I've had the oily stools but so what?That's what it does, and I've never had these side effects with "no control", other people have told me that and it's usually coz they eat junk, or more than 2000 cal/day - do what the manufacturers say and there's no problems, just oily discharge when yo[Show More]Hmmm, I've taken Alli for 6 months and went from 87kg to 76kg with exercise and pretty healthy eating plan. I've had the oily stools but so what?That's what it does, and I've never had these side effects with "no control", other people have told me that and it's usually coz they eat junk, or more than 2000 cal/day - do what the manufacturers say and there's no problems, just oily discharge when you go naturally. I will finish using Alli in 3 weeks, and my liver function tests ( as of August anyway) have all been outstanding, so I'm not bothered.
AprilOctober 9, 2009 at 3:58 pm
I have been taking Alli for less than a year. The best way to avoid the side effects is to watch what you eat. I've always wondered what it was doing to my body that I didnt know of. I read another site showing the best way to reverse liver damage... eating fruits and vegetables and purifying the liver.
otherAugust 30, 2009 at 12:43 am
I've taken it for 2 years and lost over 100 lbs. I have no issues with my liver and I believe those 32 people already had liver issues.
CarolAugust 27, 2009 at 11:50 pm
I took this medication for weight loss and I was one of the ppl who had the "bad" side effects of oil in my stools. This was not convenient and I had no control over the side effect. Now I'm worried about what it may have done to my liver. How can I find out?