Xenical, Alli Recall Petition Still Pending

Austin Kirk

By Austin Kirk
Posted October 4, 2011


The FDA has not responded to a petition filed earlier this year by the consumer advocacy group Public Citizen for an Xenical recall and Alli recall to be issued for the weight-loss drugs, which have been linked to an increased risk of liver failure, liver damage, pancreatitis and kidney failure. The Xenical and Alli lawyers at Saiontz & Kirk, P.A. represent individuals throughout the United States who have experienced these side effects, and urge the FDA to remove the orlistat medications from the market.

The prescription drug Xenical and a lower dose over-the-counter version sold as Alli both contain the active pharmaceutical ingredient orlistat, which is designed to promote weight loss when taken together with a reduced calorie low-fat diet. However, the minimal weight-loss benefits are substantially outweighed by the risk of serious and potentially life-threatening side effects of Alli and Xenical.

On April 14, 2011, Public Citizen filed a petition for the FDA to recall Alli and Xenical by banning the use of orlistat. This was actually Public Citizen’s second petition for the FDA to recall Xenical, after the FDA rejected a prior petition to remove Xenical from the market in 2006.

The FDA indicated in August 2009 that they were reviewing the potential risk of liver damage from Alli and Xenical. At that time, the agency indicated that they were aware of at least 32 reports of serious liver injury with orlistat between 1999 and October 2008, including at least 6 reports of liver failure and 27 cases that resulted in hospitalization

In April 2011, a study published in the Archives of Internal Medicine, which examined data on nearly 1,000 users of Xenical in Canada, found that about 1 in 50 users of the weight-loss drug could expect to be hospitalized for kidney problems. While researchers found that approximately 2% of users were hospitalized for kidney damage on Xenical, that compares with only about 0.5% for the rest of the population.

According to a recent analysis by Public Citizen of adverse event reports submitted to the FDA, there have also been 47 cases of acute pancreatitis and 73 cases of kidney stones, as well as at least 12 reports of severe liver injury from outside the United States.

Last month, the European Medicines Agency (EMA) indicated that a review of the risk-benefits analysis for Xenical and Alli has been launched to evaluate the risk of liver injury. If the EMA concludes that the risks outweigh the benefits, Alli and Xenical could be recalled across Europe.


The lawyers at Saiontz & Kirk, P.A. are continuing to review potential claims for individuals who may be entitled to compensation through an Xenical lawsuit or Alli lawsuit after suffering any of the following potential side effects:

  • Liver Damage
  • Liver Failure
  • Kidney Failure
  • Pancreatitis

To review a potential case for yourself, a friend or family member for health problems caused by Alli or Xenical, request a free consultation and claim evaluation.

5 Comments • Add Your Comments

  • Dolores says:

    I was taking Xenical as recommended by my doctor. Because it was so expensive he suggested I use the internet to purchase. I have to admit I did have favorable results until I could no longer afford to buy. Then Alli came out and I used these.

    Posted on April 30, 2012 at 4:41 pm

  • Cary says:

    I hope orlistat will come back as a prescription drug for there are people who need it. I have small bowel radiation damage, SIBO, inflammatory bowel disease, and divertiulosis due to complications from cancer. Needless to say, my intestines do not work properly. Per my physicians, no fresh veggies, fruit or high fiber anything, very little fruit or veg juice, all foods needed for healthy intestines are banned from my diet as they could kill me. Before Alli, pain was on a daily basis. Every 4-8 weeks I had problems with bowel obstruction and ER visits. Since I began taking orlistat (Alli) 4 yrs ago, which helped to put the fat back into the stool, I have no further ER visits. For me, one orlistat a day has been a life saver. Nothing on the market has worked and believe me I have tried them. It is terrifying to think I have to return to those pain filled days. I hope orlistat will again be released as a prescription for those of us in dire need. Doctors should be a able to keep watch on patients liver profiles. I’m sure most of those individuals with liver damage were not being monitored properly. Prescription dosage and monitoring should be benficial to all.

    Posted on May 6, 2012 at 5:45 pm

  • Leona says:

    I have taken Xenical twice now and both times i have had wonderful weight lose results with no further problems or illnesses. I went back to my gp after having my son to be put back on them to be told they are no longer available, i am totally gutted and think they should be made available again.

    Posted on January 8, 2013 at 3:41 pm

  • Dan says:

    As one who used Alli, I don’t buy any of the above agruments for any reason. It is with great regret I used the product for about six months and and staryes to bleed rectally. My prognosis stage III, rectal cancer.

    Do not use this product, its causes cancer in laboratory mice, people!

    Liver damage is just half-truths.
    If you can’t lose weight by good nutrition, or excercise…you have a problem beyond what this product could do to you.

    Dan, Portland Or.

    Posted on July 12, 2013 at 9:02 pm

  • Doug says:

    After taking Zenical I had pancreatitis several times and I now have elevated Amalyze and Lipase levels and have been diagnosed with chronic pancreatitis, which will most likely shorten my life the 20 pounds that I lost was not worth it!!

    Posted on September 18, 2013 at 7:43 pm

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