frequently asked questions

Liver injury is a broad term that covers a range of conditions ranging from one where there is a transient change in the level of enzymes produced by the liver, which may not cause any symptoms, through to inflammation of the liver (hepatitis) which in some cases may progress to structural changes and or/loss of liver function. Many different things can adversely affect the liver including certain viruses, alcohol, chemicals and some medicines. Being overweight or obese can also increase the risk of liver problems.

Orlistat, the active ingredient in alli, is being reviewed by the FDA. The FDA and regulatory agencies in other countries worldwide regularly review the safety profiles of all prescription and non-prescription medicines. GSK works closely with these agencies by providing information including data from reports from consumers who are using Orlistat (alli®) or from their healthcare professionals.

Regulatory agencies routinely review the safety information on medicines that have been approved. The FDA posted a communication on their website on 24 August 2009 about the ongoing review of cases of liver injury reported in patients taking orlistat. This does not mean that a definite association between liver injury and Orlistat (alli®) has been established. The FDA is currently advising consumers using Orlistat (alli®) to continue to use the product as directed.

• Orlistat (alli®) works in a unique way. The active ingredient, orlistat, attaches itself to some of the body’s enzymes that break down fat. This prevents some of the fat you eat from being digested and absorbed
• Fat is high in calories but if it isn't absorbed, it can't contribute to weight gain. The unabsorbed fat passes naturally out of your body in your stools.
• Unlike stimulants or appetite suppressants, Orlistat (alli®) is formulated to work only in your digestive system and should not affect your heart rate, your brain or cause sleeplessness.

To make the most of the way Orlistat (alli®) works and to help you achieve your weight loss goals, you’ll need to follow a reduced calorie, lower-fat diet and become more active.

Orlistat works primarily in the digestive system and prevents some of the fat from a meal from being absorbed. Orlistat is a non-systemically acting medicine because it acts locally in the digestive system - there is minimal absorption into the bloodstream.

A small number of reports of liver related disorders have been received globally by GSK and Roche, the manufacturers of orlistat. These reports are currently being evaluated by the FDA. The FDA has stated that no definite association between liver injury and orlistat has been established at the present time.

There have been a small number of reports of liver related disorders in patients using orlistat. However, over thirty five million people have taken this medicine worldwide since it first became available over 10 years ago as the prescription medicine, Xenical and reports of these types of disorders may be reflective of underlying disease in the overweight population.

The safety of patients is of utmost importance to GSK. The safety of all of our products is monitored in a proactive and systematic way. All of our safety information is shared on a regular basis with the regulatory agencies.

Orlistat is the most comprehensively studied weight loss medication. Its safety and efficacy have been well established through data from more than 100 clinical studies involving more than 30,000 patients. In one study alone, over 3,000 people were followed for four years while taking 120 mg orlistat. Furthermore, over 35 million people have used orlistat worldwide since it first became available over 10 years ago as the prescription medicine, Xenical.

GSK purchased the license from Roche to market orlistat 60 mg as an ‘over-the-counter’ or non-prescription medicine. GSK has an agreement to work with Roche to exchange information on the safety of orlistat.