Xenical and Alli Liver Damage Side Effects: FDA Early Communication
The FDA officially announced yesterday that they are reviewing reports that raise concerns that popular weight loss drugs containing orlistat, such as Xenical and Alli, may cause serious liver damage side effects. Although no definite association between reports of liver injury and orlistat have been established at this time, the FDA has identified this as an emerging safety issue.
>>FDA Link: Xenical and Alli Liver Injury Investigation
The product liability lawyers at Saiontz & Kirk, P.A. have been monitoring the potential for Xenical and Alli liver damage lawsuits since Scrips News reported that the FDA discussed orlistat’s potential link to hepatoxicity at an April 16 meeting of its Drug Safety Oversight Board (DSB). At that time, the FDA did not state how many post-marketing liver damage reports they were investigating, but more information was provided in an early communication issued August 24.
Xenical is a prescription medication that contains 120mg of orlistat, and Alli is an over-the-counter product that contains 60mg of orlistat. Both drugs are used to promote weight loss when taken together with a reduced calorie and low-fat diet.
According to the new information provided by the FDA:
- Between 1999 and October 2008, 32 reports of serious liver injury have been submitted to the FDA’s Adverse Event Reporting System
- 6 of the reports involved liver failure
- 27 of the cases resulted in hospitalization
- 30 of the 32 reports occurred outside the United States
- The most commonly reported adverse events included jaundice (yellowing of the skin or whites of the eyes), weakness and abdominal pain
- Other data on suspected cases of liver injury submitted by the manufacturers of olistate are also being reviewed
An early communication does not mean that there is a causal relationship between Alli and Xenical with the emerging liver damage reports. It also does not mean that the FDA is advising healthcare professionals or consumers to discontinue the products. In fact, the FDA indicated that the products should continue to be used as prescribed or directed at this time.
The FDA releases information like this based on current analysis of available data concerning potential Alli and Xenical side effects. The agency indicates that they will release additional findings concerning orlistat once their review is complete, which will also likely include any conclusions about whether the information warrants regulatory actions, like stronger warnings.
ALLI AND XENICAL LIVER INJURY LAWSUITS
At this time, the lawyers at Saiontz & Kirk, P.A. are continuing to closely follow this investigation to determine whether users the orlistat drugs who suffered a serious or fatal liver injury may be entitled to compensation through an Alli lawsuit or Xenical lawsuit.
If you, a friend or family member have been diagnosed with liver failure, liver injury or hepatitis after taking Alli or Xenical, you can submit information to be reviewed as part of our evaluation of this potential litigation by requesting a free claim evaluation.