Alli is the brand name for over-the-counter orlistat, marketed by GlaxoSmithKline. Orlistat is a weight loss drug that also comes in prescription strength for the treatment of obesity. Alli contains 60 mg orlistat, while the prescription-strength form--Xenical--contains 120 mg orlistat.
How Alli Works (How Orlistat Works)
Alli is taken up to three times a day just before meals. Alli works by limiting the ability of lipase, an enzyme in the body that breaks down fat in the digestive tract. Because the fat is not completely broken down by the disabled lipase, the body cannot absorb all the fat ingested during a meal. According to the Alli website, Alli works to prevent about a quarter of the fat eaten from being absorbed. This, in turn, helps aid in reducing caloric intake and promoting weight loss.
While there has been a fair amount reported on Alli side effects--such as loose or runny stools, diarrhea, urgent bowel movements, gas with oily spotting, and abdominal pain--reports of serious liver injury have received worldwide attention. Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA's Adverse Event Reporting System. Thirty of the 32 reports occurred outside the United States. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain. Hospitalization was reported in 27 of the 32 cases.
Orlistat Side Effects
In 2007, Alli (orlistat 60mg) was approved for over-the-counter use for weight loss in overweight adults, 18 years and older, in conjunction with a reduced-calorie and low-fat diet. Currently, orlistat is approved for marketing in approximately 100 countries. In January 2009, a nonprescription version of orlistat was approved for sale in the European Union.
In 2011, the European Medicines Agency said it was investigating Alli following reports of severe liver injury. The EMA said it was reviewing medications that contained orlistat to analyze the strength of evidence linking orlistat to severe liver injury. According to the EMA, there were 21 cases of liver injury linked to patients taking 120 mg of orlistat between August 2008 and January 2011. Four of those cases were reportedly severe.
Alli Liver Injury Investigation in Europe
In May 2010, the FDA issued a drug safety communication for orlistat (see FDA Alli warning information). After conducting a post-market safety review of orlistat, the agency determined that a new warning should be added to the labels of both prescription Xenical and over-the-counter Alli to inform users about the potential for serious liver injury.
Orlistat FDA Warning: Xenical, Alli Serious Liver Injury
While the FDA stated that a cause and effect relationship between orlistat (Alli, Xenical) and severe liver injury has not been established, the agency added the new label information to educate the public about the signs and symptoms of liver injury.
The FDA also advised healthcare professionals that cases of severe liver injury among Alli and Xenical users, although rare, had been reported and that some cases resulted in liver transplant or death.
In April 2011, consumer watchdog group, Public Citizen, issued a petition to the FDA calling for the removal of Alli and Xenical from the market. According to Public Citizen, information from the FDA AERS (Adverse Event Reporting System) indicated that not only had Alli and Xenical been linked to severe liver injury, but also to reports of acute pancreatitis (47 cases) and kidney stones (73 cases).
Public Citizen Calls for Alli, Xenical Ban
The organization sought a ban of both Alli and Xenical stating the potential for harmful side effects outweighs the possible benefits of the drugs, and that the weight loss benefits are "questionable, because neither has been shown to be much more effective than diet and exercise."
Alli Orlistat Liver Damage Legal HelpIf you or a loved one has suffered adverse health effects from using this drug, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
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