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Xenical Side Effects May Lead To Permanent Kidney Damage, Liver Damage, other Organ Damage Lawsuits

Xenical | Lawsuits, Lawyers | Side Effects: Permanent Kidney Damage, Liver Injuries, Liver Damage, Abdominal Pain, Liver Failures, and other Organ Damage

The Food & Drug Administration (FDA) is conducting a safety review of orlistat, the popular weight-loss drug sold over-the-counter as Alli, and in prescription form under the name Xenical.  According to the agency, Xenical and Alli have been associated with more than 2 dozen reports of liver injuries.

Xenical, which is made by Roche, was approved in 1999. Alli, a lower-dose version of the drug that is made by GlaxoSmithKline, was approved for over-the-counter sales last year. Alli became enormously popular as soon as it hit stores, generating sales of $131 million in its first full year on the market.

Unlike other weight loss remedies, neither Alli nor Xenical work by suppressing the appetite or increasing metabolism. Instead, orlistat prevents the digestive system from absorbing dietary fat, thereby reducing daily calorie intake. Both Alli and Xenical are meant to be used in conjunction with a low-fat diet.

According to an FDA Early Communication issued today, between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using a version of orlistat were submitted to the FDA’s Adverse Event Reporting System.  the agency said 30 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.

Despite the safety review, the FDA is not advising healthcare professionals to change their prescribing practices with orlistat. The agency said consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed. However, users of either drug should consult their health care professional if they are experiencing symptoms possibly associated with the use of orlistat and development of liver injury, particularly weakness or fatigue, fever, jaundice or brown urine. Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.

The FDA said it will  communicate its findings to the public as soon as its review of orlistat is complete.

Legal Help For Victims Affected By Xenical

If You Have Been injured, Get The Help You Need. If you or somebody you know took Xenical and developed liver damage, our attorneys can help. Call now or fill out our form for a free case review or call us anytime at 1-800-YOURLAWYER (1-800-968-7529).


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Study confirms liver, kidney toxicity risks of weight loss drugs, finds a new danger

Dec 11, 2012
A new study underscores the dangers of a popular weight-loss drug available in both prescription and over-the-counter forms and it also presents a new and potentially more serious reaction. reports on a new study from researchers at University of Rhode Island who found the drug orlistat, sold over-the-counter as alli and in prescription form as Xenical, increase a person's risk of experiencing "severe toxicity" of their liver, kidneys, or other internal organs. Several other studies...

Europe Regulators Launch New Orlistat Review

Sep 26, 2011 | Parker Waichman LLP
European regulators have launched a safety review of the orlistat-containing medications, Alli and Xenical, following more reports of liver problems linked to the drugs.  At least four of the reports involved serious liver problems in patients who had taken 120 mg orlistat (Xenical), one of which was fatal.Both Xenical and Alli prevent fat from being absorbed by the body.  Alli is sold over the counter and contains 60 mg of orlistat, while Xenical is sold via prescription...

Alli, Xenical Get Warnings For Severe Liver Injury

May 27, 2010 | Parker Waichman LLP
The safety labels for Xenical, and its over-the-counter counterpart, Alli, are being modified to include information about potential rare occurrences of severe liver injury in patients, the U.S. Food & Drug Administration (FDA) announced yesterday. The popular weight loss medications have been used by an estimated 40 million people worldwide. Both Xenical and Alli contain the same active ingredient, orlistat. Prescription Xenical contains 120 milligrams of orlistat. Alli, sold...

Glaxo Defends Alli Safety Record

Sep 14, 2009 | Parker Waichman LLP
Last month we wrote that the U.S. Food & Drug Administration (FDA) was conducting a safety review of orlistat, the popular weight-loss drug sold over-the-counter as Alli, and its prescription version, Xenical. According to the agency, Xenical and Alli have been associated with dozens of reports of liver injuries. Now, Alli maker, GlaxoSmithKline, is struggling to improve its image following dropping sales as a result of the investigation.According to the Associated Press (AP), Alli sales...

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