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Dangerous Medication
 
THE LAW FIRM OF ALLEN L. ROTHENBERG

FDA ALERT
alli
xenical
We can help. If you have suffered from any of the deadly side effects while taking Alli® or Xenical® (orlistat) or if a loved one has been severely injured while on Alli or Xenical please fill out the form on this page or call 1-800-624-8888.

Food and Drug Administration Issues Safety Alert on
ALLI / XENICAL (Orlistat)

FDA is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli.
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.
Alli

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.

Dangerous side effects of Alli or Xenical may include:
  • Liver Damage
    		•
  • Weakness or Fatigue
    		•
  • Brown Urine
    		•
  • Jaundice
    		•
  • Vomiting
    		•
  • Nausea
    		•
    If you or a loved one has taken All® or Xenical® and developed any of the dangerous side effects listed above, please contact
    The Law Firm of Allen L. Rothenberg
    1-800-624-8888 or 1-800-ROTHENBERG
    for a free consultation or submit a free online case evaluation.
    The case evaluation is free, and remember, we charge no fee unless we get you money.
    ©2010 The Law Firm of Allen L. Rothenberg. The Injury Lawyer. DangerousMedication.com All rights reserved.
    While this firm maintains joint responsibility, cases of this type may be referred to co-counsel for principal responsibility