This past February the FDA approved Alli, an over-the-counter version of the diet drug Orlistat (Xenical) manufactured by GlaxoSmithKline. The company's website, myalli.com, and literature offer the potential for greater weight loss than dieting alone if you do everything right and a warning of unpleasant and embarrassing side effects if you don't.

The drug was introduced as the stronger, prescription-only Xenical several years ago. It works in the digestive system by blocking the absorption of about 25% of fat that is consumed. In a theoretical 3,000 calorie-a-day diet with about 100 grams of fat, the drug would eliminate about 225 calories. But it can also result in what the manufacturer describes as loose stools and gas with an oily discharge. "It's probably a smart idea to wear dark pants, and bring a change of clothes with you to work," the drug's official website says.

Natural health researcher Mike Adams (newstarget.com) offers his opinion of Alli in a featured article "Miracle" weight loss drug Alli delivers more than you bargained for-diapers optional):

When it comes to weight loss, consumers are looking for a magic bullet -- a miracle pill that eliminates the responsibility of having to actually make adult decisions about their own health. GlaxoSmithKline has delivered the pot-of-weight-loss-gold at the end of the rainbow in the form of an over-the-counter drug called, "Alli." While Alli will no doubt be a huge commercial success, it will prove to be an utter weight loss failure. Even in clinical trials, the drug only produced a few pounds of weight loss per year. You could lose more by walking five minutes a day, or drinking half a can of soda less than what you do now. As a serious weight loss aid, Alli falls short. Very short. I'm also concerned about the fact that the drug interferes with the absorption of essential fatty acids. Given that most overweight people are already extremely deficient in omega-3 fatty acids, DHA and other healthy oils, this Alli drug is likely to put them in an even worse state of deficiency.

Speaking of shorts, Adams continues, "Alli has some very entertaining side effects. The drug can cause explosive oily stools to involuntarily eject from your bowels. While that may sound like fun if you're at a frat party, it's certainly not an enjoyable experience when commuting, driving, or hanging out at the office. Dirtying your britches is bound to make the gossip rounds in mere minutes, earning you new nicknames and a repulsive, date-spoiling reputation that will be difficult to overcome. The manufacturer of Alli actually recommends that consumers "carry an extra pair of pants" with them at all times, just in case the side effects kick in. Why not just wear diapers?"

Another health concern is that Orlistat, for the past 10 years, had been shown to cause pre-cancerous lesions of the colon. From an article featured on the website mercola.com, Doctors Outraged--FDA Ignored Cancer Risk When Approving Alli 7/07:

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 showing that:

• 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.

Dr. Joseph Mercola added this comment: "The sad truth is, although obesity is rampant, OTC diet pills are often purchased by women who are not obese at all. One of Public Citizen's main concerns over the approval of Alli for over-the-counter sale, is that countless numbers of people will expose themselves to radical and unnecessary health risks, for no reason whatsoever. I agree with their sentiment."

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