Skip to content
My WebMD Sign In, Sign Up

Weight Loss & Diet Plans

Font Size

FDA: Alli, Xenical Linked to Rare Liver Injury

Alli, Xenical Labels to Warn of Rare but Severe Liver Injury
By
WebMD Health News
Reviewed by Laura J. Martin, MD

May 26, 2010 -- The popular weight loss products Alli and Xenical have been linked to a rare but severe form of liver injury, the FDA today warned.

The risk appears tiny. Worldwide, there have been only 13 cases among the 40 million people who have used the products. However, two of these people died and three others required liver transplants.

Alli and Xenical contain the weight loss drug orlistat. Xenical, made by Roche's Genentech, contains 120 milligrams of orlistat and is available only by prescription. Alli, from GlaxoSmithKline, contains 60 milligrams of orlistat and is available over the counter.

In 2009, the FDA announced it was reviewing 32 reports of liver injury in people taking Alli or Xenical. That review has now identified 13 cases, one in the U.S., of liver death or liver failure.

The fact that these patients were using the products does not necessarily mean the products caused the liver injury. Some of the patients were taking other drugs or had other conditions that may have contributed to the injury.

Nevertheless, the labels for Alli and Xenical will now carry warnings about the possible risk of liver injury.

Symptoms of liver injury include:

  • Loss of appetite
  • Itching
  • Yellow eyes or skin
  • Dark urine
  • Light-colored stools

People concerned about the possibility of liver injury should consult a doctor.

In a news release, GlaxoSmithKline (GSK) said it was cooperating with the FDA in conjunction with Roche.

"GSK is committed to ensuring that consumers and physicians understand the safety profile of orlistat and Alli. Although reports of serious liver injury in people taking orlistat are rare, GSK takes all adverse events reports seriously," Howard Marsh, MD, chief medical officer for GSK Consumer Healthcare, says in a news release.

Today on WebMD

measuring waist
4 tips for shedding yours.
apple cider vinegar
Does it have health benefits?
 
Chocolate truffle
For weight loss, some aren’t so bad after all.
woman holding red dress
24 simple, practical tips.
 
woman shopping fresh produce
Video
butter curl on knife
Quiz
 
eating out healthy
Article
Smiling woman, red hair
Article
 
thumbnail_woman_tossing_spinach
Video
lunchbox
Article
 
What Girls Need To Know About Eating Disorders
Article
teen squeezing into jeans
fitfor Teens
 

Special Sections