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. According to the manufacturer, the active ingredient in Alli attaches to some of the natural enzymes in the digestive system, preventing them from breaking down about a quarter of the fat you eat.
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 usual 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.
Alli Claims it it is Safe
In a press release GSK, stated "...alli (60 mg orlistat capsules) is safe and effective when used as directed. As the most extensively studied weight-loss medication on the market, the safety and efficacy of orlistat is very well established..."
The manufacturer alleges that 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.
Alli & Orlistat the OTC Version of Xenical
Xenical (orlistat 120mg) was approved as a prescription product by FDA in 1999 for obesity management in conjunction with a reduced caloric diet, and to reduce the risk of regaining weight after prior weight loss. In 2007, Alli (orlistat 60mg) was approved for OTC use for weight loss in overweight adults, 18 years and older, in conjunction with a reduced-calorie and low-fat diet. Currently, orlistat is approved for marketing in approximately 100 countries. In January 2009, a nonprescription version of orlistat was approved for sale in the European Union.
FDA Alli Warning - Liver Injury & Liver Damage Reported to FDA
Between 1999 and October 2008, 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. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain. Hospitalization was reported in 27 of the 32 cases.
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 issues here are complex, but FDA has benefited from the input of the Board, including comments from representatives from three FDA Centers and several other Agencies in the Department of Health and Human Services," said Steven Osborne, M.D., executive director of the 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. 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.
Alli Injury Lawsuit & Alli Liver Damage Lawsuits
If you or a loved one have taken ALLI and been diagnosed with liver damage, liver failure, jaundice, high or elevated liver enzymes and had a liver transplant, then call us to discuss your legal rights to monetary damages for these Alli related injuries. Just because FDA has not announced recall of Alli, an injured consumer with liver damage can still file a lawsuit for their liver injury. If you have experienced other problems from Alli including unexplained gall bladder problems, gall bladder pains or even had to have a gall bladder removal or surgery, then call us to discuss any concerns regarding Alli and Gall Bladder Problems. Though Alli related gall bladder problems was not mentioned by FDA, we have had several clients have informed us of these complaints and we would like to gather more information on the matter.
The Willis Law Firm has represented thousands of clients across the United States in defective and recalled medical devices, herbal & (OTC) Over the Counter medications, drugs, recalled drugs and other product liability claims. Mr. Willis is a Board Certified Trial Lawyer with 25+ years of legal experience. Call and talk to the Willis Law Firm about your legal rights in an alli diet drug lawsuit and information about an alli class action lawsuit.
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