FDA issues Alli Warning

August 25, 2009, The U.S. Food and Drug Administration (FDA) announced that it is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical and the over-the-counter medication Alli.  Between 1999 and 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain. NOTE: Some cases of severe Alli liver damage and liver failure have been reported to the FDA.

***If you have taken Alli and are having any medical problems or have questions about Alli Liver Testing, then we encourage you to contact your physician for liver enzyme tests or other appropriate liver testing to make sure you are alright.

Alli Works by Passing Fat

Alli claims that undigested fat cannot be absorbed and passes through the body naturally. Because of the way in which alli works, eating meals with too much fat may cause the patient to unusual bowel side effects including: gas with oily spotting, loose stools and more frequent stools that may be hard to control. Alli only works on enzymes that break down fat, not on other enzymes. So carbohydrates and proteins are not affected. You still absorb those nutrients. But, since fat grams have more than twice as many calories as carbs and proteins, alli capsules work on the worst offenders - the calorie-dense fat grams.

Glaxo Smith Kline (GSK) the manufacturer of alli, claims alli is safe when used as directed - it works only in your digestive system, not in your heart or brain. thereby reducing the users jittery effects, sleeplessness and a racing heart.

As indicated above 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. In addition to the 32 reported cases, this issue was discussed at the CDER Drug Safety Oversight Board in April 2009, and FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat. FDA's analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time.

The FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at the FDA's Center for Drug Evaluation and Research Drug Safety Oversight Board."The FDA's analysis of these data is ongoing, and no definite association between liver injury and orlistat has been established at this time. GSK has not announced any Alli Recall due to liver damage injuries to consumers. Consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.

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