In February 2007, the FDA approved Alli--an over-the-counter version of the diet drug Orlistat (Xenical).

The Public Citizen's Health Research Group has voiced concerns about Orlistat’s safety and efficacy for the past 10 years, as it's been shown to cause pre-cancerous lesions of the colon.

In April of 2006, a group of doctors with Public Citizen petitioned the FDA to ban Orlistat and deny OTC status to the lower dosage version Alli, offering testimony that Orlistat raises the risk of both colon cancer and gallstones.

Public Citizen cited unpublished studies on Orlistat, showing:

• Orlistat increases the precursor markers to colon cancer by 60 percent in rats.
• When eating a high fat diet and taking Orlistat, the cancer risk increased 2.4 fold.
• Fat soluble vitamin E depletion, due to Orlistat's fat blocking action, raises the risk of colon cancer even further.
• Recorded adverse reactions to Orlistat include: 39 cases of increased abnormal blood thinning; several cases of bleeding episodes; 10 hospitalizations, four with life threatening reactions, and one death.
• Dangerous thinning of the blood can occur in people taking drugs like Warfarin (an anti-coagulant), or who suffer from vitamin K deficiency.

In addition, the FDA itself found 37 cases of gallstones in patients of all ages, between 1999 and 2006, prior to releasing Alli for over-the-counter sale.

The safety analysis from the Public Citizen's Health Research Group is that Alli "has marginal weight loss benefits, common and bothersome G-I tract reactions, significant decrease in absorption of fat soluble vitamins, and problematic use in the millions of people using Warfarin or Cyclosporine."

The FDA denied Public Citizen's petition on the same day they approved Alli as an OTC.

Public Citizen's Health Research Group

Statement to the FDA of Dr. Wolfe February 2007

Petition to the FDA to Remove Orlistat April 2006

Testimony Before the FDA Advisory Committee January 2006

Alli and Gallstones June 2007