Last week the U.S. Food and Drug Administration (FDA) announced the approval of revised labeling for the prescription weight-loss drug Xenical (orlistat 120 mg) and its OTC version Alli (orlistat 60 mg). 

The revised label carries new safety information regarding cases of severe liver injury that have been reported with the use of orlistat.  It is important to note that these cases have occurred only rarely, estimated at 13 cases out of the approximate 40 million people worldwide who have used this medication since its approval in 1999 (Xenical) and 2007 (Alli).

Of the 13 cases of severe livery injury, 12 were foreign reports associated with the use of Xenical and one was a U.S. report associated with Alli use.  Two patients died from liver failure and three patients required liver transplants.  A causal relationship has not been established as other factors or drugs may have contributed to the development of severe liver injury.

Wow.  Anytime a drug can cause liver damage, whether serious or severe, it is something to take seriously.  I take medication for my RA which can potentially cause liver damage or alter white/red bloodcell counts.  So I have a standing order to get blood work done every 2 months to make sure that every looks good.

Patients who use certain interferons for their MS also must have regular blood tests done to check for liver damage.  In the case of Xenical and Alli, the FDA is not recommending regular laboratory tests.  They want consumers, patients, and physicians to be aware of the potential of severe liver damage with the use of these medications.

The signs and symptoms of severe liver injury include itching, yellow eyes or skin, fever weakness, vomiting, fatigue, dark urine, light-colored stools, or loss of appetite.  If you use orlistat and experience these signs or symptoms, you should contact your doctor immediately.

Xenical and Alli are weight-loss medications which block some of the fat you eat, keeping it from being absorbed by your body.  They are used together with a reduced-calorie diet and weight maintenance to treat obesity in people with certain risk factors, such as diabetes, high blood pressure, and high cholesterol or high triglycerides.

The following side-effects are common with the use of Xenical and Alli.  Drugs.com states that they are the natural effect of the medication’s fat-blocking action and are actually signs that the medication is working properly.  These side-effects are usually temporary and may lessen are you continue treatment:

    •    oily spotting in your undergarments;
    •    oily or fatty stools;
    •    orange or brown colored oil in your stool;
    •    gas with discharge, an oily discharge;
    •    loose stools, or an urgent need to go to the bathroom, inability to control bowel movements;