New Warnings on Weight Loss Drugs Alli and Xenical

New Warnings on Weight Loss Drugs Alli and Xenical
Given the preponderance of obesity in America, and elsewhere in the world, it is not surprising that more and more people are turning to alternative means of losing weight, in addition to or rather than the tried-and-true exercise-diet combination. Orlistat, sold under the brands Alli and Xenical, is the FDA-approved weight loss drug that is the most popular, but repeated studies show that there is a real danger of both liver and kidney damage from their use and consumers should beware.

In August of 2009, the U.S. Food and Drug Administration (FDA) issued an Early Communication regarding an ongoing safety review of the drug after receiving a total of 32 reports of serious liver injury in patients taking orlistat. Of the 32 cases of liver injury reported, 27 required hospitalization, with six resulting in liver failure. In May of 2010, the FDA announced that it would require liver-injury warnings on both Alli (sold over the counter) and Xenical (available through prescription).

Now Canadian researchers have discovered an increase in kidney damage among patients taking orlistat. Searching through Canadian health data, they found that 0.5 percent of patients prescribed the drug were hospitalized for kidney problems in the year prior to treatment. That hospitalization rate rose to 2 percent after patients had been on the drug for a year.

Orlistat works by blocking the absorption of ingested dietary fats. The FDA approved Xenical (orlistat 120mg) as a prescription product in 1999 for the purpose of obesity management, to be taken in conjunction with a reduced caloric diet. The over-the-counter version, orlistat 60 mg which is sold as Alli, was approved for use by overweight adults ages 18 and older in 2007.

Alli pamphlets state that the drug is only expected to help lose 5 to 10 pound in 6 months. Some dieters feel the small amount of weight loss could be accomplished by cutting out a few soft drinks weekly without taking the diet pill. In addition there are some unpleasant side effects reported with Alli, namely, leakages and oily discharge that can cause soiled underwear. Prior to the drug launch there was marketing materials for the new drug that stressed the importance of keeping meals under 15 grams of fat to avoid this problem. Some pamphlets even recommended starting the program when off of work.

The consumer group Public Citizen is demanding that the FDA remove these drugs from the marketplace due to repeated reports and studies of adverse side effects to liver, kidneys and the pancreas. While these side effects are serious, they only affect a very small portion of the 40 million people who have taken a version of orlistat. Dr. Richard Besser, Senior Health and Medical Editor for ABC News said “that although 40 million people have tried the drug, only 13 cases of liver failure, 47 cases of acute pancreatitis and 73 cases of kidney stones have been reported, and there are no studies to show that these conditions were actually caused by taking the weight loss drugs.” But buyer beware.

Popular Posts

Blog Archive