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Xenical liver injuries have been reported to the U.S. Food and Drug Administration (FDA) ever since it was approved for use as a weight loss drug in 1999. Xenical (orlistat is its generic drug name) works by blocking the absorption of fat consumed, and it was designed to be used along with a good diet and exercise.

Xenical: One of the Weight Loss Drugs

Xenical, made by Roche Laboratories, is used in 120-mg doses. The generic version, sols over-the-counter (OTC), orlistat, was approved by the FDA in 2007 — at 60 mg. Alli, made by a different company GlaxoSmithKline, is the same drug, also sold over-the-counter. Clinical research programs have established that orlistat, whether in the form of Xenical or Alli, has many potential negative side effects, including:

• intestinal gas with oily discharge
• increased number of bowel movements
• an urgent need to have bowel movements
• inability to control bowel movements
• numbness and tingling
• yellowing of the skin or whites of the eyes (i.e., jaundice)
• weakness and stomach pain

FDA's Early Communication about Xenical Liver Injuries

On Aug. 24, 2009, the FDA released an Early Communication about Xenical and liver injuries, noting that their Center of Drug Evaluation and Research (CDER) has received 32 reports of Xenical-linked liver injuries since 1999. Of the patients affected, 27 were hospitalized for their liver injuries and six experienced liver failure. The CDER is reviewing additional data from Roche and GSK about suspected cases of liver injuries.

Symptoms of Liver Injuries

All drugs — whether for weight loss or another indication — have some side effects for some people. However, the FDA says that anyone who has used Xenical/Alli/orlistat should seek medical attention if they experience symptoms of liver injury, which includes:

• abdominal pain
• brown urine
• fever
• itching
• jaundice
• light-colored stools
• loss of appetite
• nausea
• vomiting
• weakness/fatigue

A spokesman for Roche Laboratories, Terry Hurley, responded to the FDA's Early Communication, stating that "Patient safety is very important to us and we continue to work very closely with the FDA. At this time, per the FDA's alert, no causal relationship can be established and changes in prescribing are not recommended."

Speak to an Attorney about Xenical Liver Injuries

Patients who experience liver injuries can also report their cases to the FDA's MedWatch Adverse Event Reporting program. A Xenical plaintiffs' attorney can provide a great deal of information about liver injuries and the legal rights of individuals who have suffered harm from Xenical, Alli, or another drug.

Consult a Xenical lawyer in your area who is knowledgeable about Xenical liver injuries, and learn about your legal options. It's best to stay well informed.