FDA Issues Update on Safety Review of Orlistat (Alli and Xenical)

Liver Damage Reported

The 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.

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.

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.

AUG-24-09: FDA Issues Update on Safety Review Orlistat [FDA: LIVER DAMAGE REPORTED WITH ORLISTAT]

Legal Help

If you or a loved one has suffered adverse health effects from using this drug, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.

Related Law Suits

FDA Issues Update on Safety Review Orlistat Law Suit and Settlement

FDA Issues Early Safety Communication About Meridia Diet Pill Law Suit and Settlement

FDA Issues Safety Warning About Valproic Acid and Divalproex Sodium Law Suit and Settlement

UPDATE 1: Caraco Digoxin Recall Law Suit and Settlement

FDA Review of Prostate Cancer Treatment Prompts Warning of Risk for Diabetes Law Suit and Settlement

Health Canada Issues Warning Law Suit and Settlement

FDA Issues Warning about Promethazine Hydrochloride Injection Law Suit and Settlement

FDA Issues Warning Regarding Topical Ibuprofen Drug Products Law Suit and Settlement

Clopidogrel Marketed as Plavix FDA Issues Public Health Advisory Law Suit and Settlement

FFDA Issues Warning about Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution Law Suit and Settlement

See more stories from this source.

Class Action Law Suits

Newsworthy Law Suits
Defective Products Lawsuits
Discrimination Lawsuits
Drug & Medical Claims Lawsuits
Food & Dietary Supplement Lawsuits
Insurance Lawsuits
Malpractice Lawsuits
Personal Injury Lawsuits
Real Estate Lawsuits
Investment Fraud Lawsuits

Related Law Articles

Employee Lawsuits (An Introduction and Topic Overview)
How employers can cope with the siege of employee lawsuits

Mitchell Report Summary
Report on Steroid Drug Use in Major League Baseball by Senator George Mitchell

Employee Lawsuits: Negligent Hiring and Retention
Employers must check references, criminal records, other background material.

Paxil Lawsuit
Paxil Claims, Lawsuits, and Injuries

National Practitioner Data Bank Fact
NPDB identifies unprofessional healthcare practitioners

Military Veterans Benefits
How to obtain full range of benefits for veterans and dependnets

is===1

Related Law Questions

Did I harass someone?
Oh, yes. This can be taken in as so many things, especially since you had testif...

Can failure of an employer to provide healthy working conditions lead to wrongful discharge?
The Occupational Safety & Health Administration (OSHA) protects workers from...

What role does financial means determine which parent gains custody?
was(am) a single male that gained custody of my daughter when she was three. Thi...

Am I liable for back rent to a roommate who would physically abuse me, which is what forced me to leave?
I suggest U talk to a Legal Aid Attorney with housing law experience. Or the alt...

How can I prove my wife only married me to get a green card?
The problem with an annulment is that they are hard to get-- they are not someth...

Related Law Bulletins

Medical Malpractice: NY MD's Malpractice Ins. Premiums- Is $170,000 enough?
Obstetricians and neurosurgeons in New York pay over $170,000 per ...

$16 Million Jury Award for Heart Attack Death Among Largest Medical Malpractice Verdicts in Connecticut
October 3, 2007 issue of Newsday reports: "BRIDGEPORT, Conn. - A S...

Insurance Department Issues Second Annual Ohio Medical Liability Closed Claim Report
COLUMBUS — The Ohio Department of Insurance has issued its secon...

Medical Malpractice: Your Case Is On The Trial Calendar-Can Defense Lawyers Talk to Your Doctor?
Your New York attorney has notified the Court that your case is re...

Medical Malpractice - Your Child's Been Diagnosed With Brain Damage and Cerebral Palsy
You're in labor. Your due date is tomorrow. Your contractions are ...

Lawyers! Become an Approved Expert to Answer Questions.

Apply Now!
You'll get lots of targetted traffic to your website and new client leads!