Weight Loss Drugs, Xenical and Alli, Receive New FDA Warning Label

Patient Expert

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;

an increased number of bowel movements;

stomach pain, nausea, vomiting, diarrhea, rectal pain; or

weakness, dark urine, clay-colored stools, itching, loss of appetite, or jaundice (yellowing of the skin or eyes).

Other side effects that may occur while taking Xenical include:

problems with your teeth or gums;

cold symptoms such as stuffy nose, sneezing, cough;

fever, chills, sore throat, flu symptoms;

headache, back pain; or

mild skin rash.

Notice that the symptoms of severe liver injury overlap with common side-effects of orlistat use. Side-effects other than those listed here may also occur. Talk to your doctor about any side-effect that seem unusual or are especially bothersome. You may report side effects to FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch and click on "How to Report."

During the FDA's initial review, 32 reports of serious liver injury were identified, including 6 cases of liver failure. Then the FDA conducted a comprehensive review of available data on** severe** liver injury associated with Xenical through August 7, 2009, and a review of post-marketing data on Alli from 2007 through October 1, 2008. It was during this comprehensive review that the 13 cases of severe liver injury were identified.

The FDA stresses that some patients in the reported cases also used other drugs or had other conditions that may have contributed to the development of severe liver injury. Severe livery injury can occur in people not taking drugs and without a distinct cause.

I have never used Xenical nor Alli. In fact, I've never used any weight-loss prescription medication. Back in college I tried an appetite suppressant for a short period of time but it didn't seem to benefit me so I stopped.

What about you.

Have you taken any prescription or OTC weight-loss medications?** Do you use Xenical or Alli?**** Would you call your doctor if you noticed any of the potential and rare side-effects mentioned above?**
Ever since reading the FDA announcement last week, it seems that the Alli commercials are much more prominent. Actually it's probably just that I'm more aware and noticing the product mentions whereas before I would tune out the commercials entirely.

SOURCES: The May 26, 2010 FDA announcement regarding Xenical and Alli.

Xenical information at Drugs.com.

May 23, 2010
Weight: 246.5 lbs
Blood Pressure: 120/79
Pulse: 68

May 30, 2010
Weight: 242.1 lbs
Blood Pressure: 119/72
Pulse: 65