Xenical and Alli Receive FDA Liver Damage Warning

Posted on May 27th 2010 2:00PM by Hilary Walke

Getty Images/Jeff J Mitchell

The U.S. Food and Drug Administration has approved two new warnings for prescription weight-loss drug Xenical and over-the-counter pill Alli, making it clear to consumers that both drugs have had reports of severe liver injury.

The active ingredient that both drugs share, called orlistat, can cause liver damage. Symptoms include itching, yellow eyes or skin, dark urine, light-colored stools or loss of appetite. The FDA advises patients to stop taking either medicine and seek medical attention if they notice these symptoms.

Orlistat has been on the market for years, so why is the FDA issuing a warning now?

"The FDA said it reviewed 12 cases of severe liver damage in patients outside the United States who took Xenical, and one in a U.S. patient who took Alli," according to Reuters. "Two died and three needed liver transplants."

Because the liver injuries have been so severe, the labels of Xenical and Alli now have information about reported cases of severe liver damage. While the warning label on Alli will stress that these reports have been rare, the company claims it does want "people to have the information they need to choose the right weight loss aid for their situation," said Dr. Howard Marsh, chief medical officer for GSK Consumer Healthcare, the maker of Xenical and Alli.

According to the FDA, an estimated 40 million people worldwide having consumed Xenical or Alli.

Check out our diet and weight loss tips for safe and healthy tips on shedding pounds.

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Tags: Alli, diet pills, drugs, prescription drugs, weight loss drugs, weight loss pills, Xenical

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Reader Comments (Page 1 of 1)

V Van Mullem 5-29-2010 @ 6:52PM

I think liver damage should be determined before the product is mass marketed over the counter. Just sayin'...seems like profits over safety wins every time.

Joanna 5-27-2010 @ 3:07PM

So if your obese you take Alli and you could get liver trouble, but if you stay obese you could die from a heart attack or a stroke or diabetes. You just can't win.

Grammie 6-01-2010 @ 1:49PM

You can definitely win by using common sense and making good food choices. Nothing can beat proper diet and exercise for taking off the weight and keeping it off. As a yo-yo dieter, I know what I'm talking about.

DLM 5-27-2010 @ 3:42PM

You don't need pills to lose weight. Once you stop taking the pills, you gain it all back and then some. Eat right, and exercise and you'll lose. It takes time, there is no quick fix for losing weight. You didn't gain it all in a week, you won't lose it in a week.

Jennifer 5-27-2010 @ 5:32PM

To DLM, in response to your slightly doomsday response, I must disagree on a couple points. Although you're right that realistically you don't need pills to lose weight, many people don't lose weight without the pills because the results are slower than they need to keep them motivated to keep at it. I've been taking Alli for over 3 months (and have lost 22 pounds I might add!) and because I've been losing weight consistently without having to give up any of my favorite foods I have stayed motivated to keep going. And with fad diets I agree that you will probably gain it right back because you haven't learned any good habits, but [because I didn't want to experience Alli's dreaded side effects] I have practiced eating less than 15 grams of fat per meal for over 3 months and have, for the first time in my life, learned how to eat all foods in moderation. Alli was exactly what I needed. I will keep an eye out for yellow eyeballs though.

jcbrod1 5-27-2010 @ 3:50PM

why would the drug be allowed to stay on the market if it can kill you? When it first came out i contacted the compny and asked it could be either opend up or crushed with food as I cannot swallow pills. They told me they could not answer that question as it had never been tested that way. i never took that drug after that ignorant answer

JP 5-27-2010 @ 4:40PM

If they took every drug off the market that can kill you there would be no drugs. We'd all be making willow bark tea for a headache.

Lisa 5-28-2010 @ 3:56PM

Twelve cases out of 40,000,000 people using it. Thats .00003%. I think the likelihood of death or serious disability from obesity is far greater.

Maxx 5-27-2010 @ 4:09PM

I warned the FDA about these two (one in the same) diet remedies in 2006, but they didn't listen. They never even responded to my email!

Go Work People.

Jo Ann Johnson 5-27-2010 @ 5:14PM

Hogwash! I used xenical for a year and just 4 mos. ago I had labs done and everything was great. I also was diagnosed with Hep c in 99. My Dr. is amazed that I have a very low virus count less than 28,000. I don't believe a word the FDA says. They want us to stay sick and fat. They are in league with the pharmacutical companies to make more money . I take plenty of vitamins and do my best to eat right. My only complaint about xenical is that you lose about 15 lbs. and thats it. one u stop taking it , the weight come right back as with every product out there. The best way to lose weight is exercise daily.

dooks 5-27-2010 @ 11:49PM

Please at least get a foot model with pretty toes for heaven's sake...

sheri 5-27-2010 @ 7:37PM

13 cases out of 40 million users. Use your brains. 13 people out of 40 million, don't you think these people would have had these side effects without the drug. Just so you know, if you are in a drug study or taking a drug and you say to your doctor, my back hurts, they must report it. Even if you are on a toe medication. Anything a patient reports must be reported. 13 fat people with liver problems is not a surprise.

Sophia 5-27-2010 @ 8:26PM

EXCUSE ME !!! There is a LOT OF INFORMATION MISSING in this article (news item).

First: There have always been warnings on both drugs regarding the potential for liver damage. Advisable to get a check up BEFORE starting either drug.

Second: What is missing from this 'data' is how often the patients who developed liver problems took the medication, what other medications they may have been taking, what kind of life style did they lead (how much alcohol was involved...etc.) and much more needed data for us to make an informed decision.

Third: Any drug (medication) has a risk. EVEN ASPIRIN can cause liver damage. The information on possible liver damage didn't just surface ! IT'S BEEN THERE FROM DAY ONE. The problem is those who abuse it, just as those who abuse any medication are the ones you hear about. You won't hear about the thousands who benefited from the medication. I BELIEVE ANYONE WHO FOLLOWS THEIR DOCTORS ADVICE (OR THE DIRECTIONS ON THE BOX/CONTAINER) SHOULD FOLLOW THOSE DIRECTIONS. IT'S THE ONES WHO DON'T THAT HURT THE REST OF THE POPULATION WHO COULD BENEFIT FROM IT.

Years ago, there were medications for weight loss and there were those who abused it. Even some who only needed/wanted to lose 10 pounds used it for years. Consequently, they developed heart problems OR had undiagnosed heart problems BEFORE starting to take the medication. People need to use common sense. You don't need medication to lose 10 pounds. You may need medication to lost 50 pounds. You should follow the advice on the labels strictly. You should consult your doctor. You should not use longer than needed and DEFINITELY NOT LONGER THAN NEEDED ! Those who abuse make the world of medications that help others a nighmare and in many cases they are ripped from the shelves.

SOMETIMES IT ISN'T A MANUFACTURER'S PROBLEM ! MANY TIMES IT'S THE USERS ABUSE THAT BECOMES THE PROBLEM AND THEY ARE THE ONES WHO MAKE PROBLEMS FOR OTHERS IN THE PROCESS.

I lost an aunt who was using one of the weight loss medications and losing weight. She had struggled most of her life with weight problems (which also caused her heart, blood pressure, etc. problems). She was on one of those medications removed (BANNED). When they were removed they replaced that with something else. It didn't work for her. She didn't lose a lot more weight. Over the course of the next two years, she continued to try to lose, exercised, etc. She lost her life in this struggle. Weight put too much pressure on her heart and brain. She had a stoke and heart attack. NOT CAUSED BY THE MEDICATION...but by the weight she was trying to lose.

PEOPLE....WE CANNOT FORM ANY KIND OF DECISION OR OPINION BASED UPON THE INFORMATION GIVEN IN THIS 'NEWS ITEM' which I think is one more propaganda attempt against weight loss medications and leading more and more people to surgery (LAPBAND come to mind). Far more risky to have this done than to use medication AS PRESCRIBED for the shortest amount of time !!!

NoT A GOOD ARTICLE AT ALL !!!