FDA to Review Alli Due to Liver Damage Concerns

Users of the popular weight loss drug, Alli, may want to keep an eye on the new FDA probe into adverse side effects, including liver damage, associated with orlistat. Orlistat is marketed as Xenical, which is only available by prescription, and also marketed in non-prescription form as Alli. Alli is marketed by GlaxoSmithKline as the "only FDA approved over-the-counter weight-loss aid" became available over the counter just over two years ago.

Alli and liver damage: What Alli users should know

Only 2 of the 32 cases of serious liver injury reported to the FDA in the past ten years occurred within the United States. As with any drug, consumers taking medication, whether prescription or over the counter, need to be aware of potential side effects. According to the FDA press release, the FDA is evaluating the adverse reports on an ongoing basis and there is no definitive correlation between the use of orlistat (Alli) and liver injuries thus far. The FDA is still recommending that patients taking orlistat via prescription (Xenical) continue doing so. The FDA also advises consumers taking Alli for weight loss to continue to use the over-the-counter product as directed.

Consumers who are taking or have taken orlistat either via prescription or in its non-prescription form as Alli should be aware of and report any negative side effects to their doctor. According to WEBMD, signs of liver injury or damage can include weakness or fatigue, jaundice, brown urine or a fever. Other symptoms of liver damage include abdominal pain, nausea, vomiting, weight loss, light colored stools and itchy skin. If a consumer experiences any of these side effects while taking Alli or Xenical they should immediately make an appointment with their physician to investigate their cause and to determine whether liver injury has occurred. Patients taking Alli over-the-counter should be sure to mention that they are using the weight loss aid whenever they visit their doctor.

Hydroxycut recall earlier this year due to possible liver damage in users

Hydroxycut, another popular weight loss diet aid, was recalled earlier this year by the FDA because of adverse reports of liver damage occurring in some individuals, even at the dosage listed on the bottle. In all, the FDA received 23 reports of liver injury associated with Hydroxycut usage, which resulted in one consumer needing a liver transplant and also resulting in one death. Hydroxycut's maker, Iovate, initiated a voluntary recall of its numerous Hydroxycut products in May.

Sources:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm180057.htm
http://www.myalli.com/
http://www.mayoclinic.com/health/liver-problems/DS01133/DSECTION=symptoms
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm152152.htm
http://www.fda.gov/Safety/Recalls/ucm145164.htm