Obesity experts say the recall of the over-the-counter fat-blocking diet pill Alli is a setback for dieters.
The maker of Alli (pronounced AL-eye) is voluntarily recalling all the weight loss products from U.S. and Puerto Rico retailers because the company believes that some packages of the product were tampered with and may contain product that is not authentic.
GlaxoSmithKline (GSK) Consumer Healthcare said it received inquiries from consumers in seven states about bottles of Alli that contained tablets and capsules that were not the weight-loss product. Alli, a non-prescription version of the drug orlistat, prevents about 25% of fat from being absorbed by the intestines.
This is a real setback for patients and doctors who are trying to manage weight to improve health, says obesity researcher Donna Ryan, professor emeritus at the Pennington Biomedical Research Center in Baton Rouge. From a patient perspective, it is a loss. Patients say the medication works. It helps them avoid tempting high-fat meals and snacks.
From a doctor's perspective, this is the only over-the-counter medication that had evidence published in peer-reviewed journals to support efficacy and safety, Ryan says. Everything else on the shelf next to it has simply a claim and almost all have no effect whatsoever. There is four-year data to support this medication as being effective in preventing weight regain.
GSK is conducting an investigation of the tampered products and is working with the Food and Drug Administration on the retailer-level recall. Safety is our first priority, said Deborah Bolding, a spokeswoman for the company. We want people to look at the Alli they have at home on their medicine shelf and make sure it's authentic.
If they think they have a product that has been tampered with, we'd like them to call us at 800-671-2554 and get the product back to us. We'll make it easy for them to get it back to us. If that product has in fact been tampered with, it will be part of the investigation, Bolding says.
Alli is a turquoise blue capsule with a dark blue band imprinted with the text 60 Orlistat, she says. It is packaged in a labeled bottle that has an inner foil seal imprinted with the words: Sealed for Your Protection. Consumers should confirm any Alli in their possession matches this description. Pictures of the product are available on the company's website, www.myalli.com.
A range of tablets and capsules of various shapes and colors were reported to be found inside bottles, Bolding says, and some bottles inside the outer carton were missing labels and had tamper-evident seals that were not authentic. These tampered products were purchased in retail stores.
Alli is offered in a 60-milligram dose and is supposed to be taken up to three times a day with meals. Those meals should contain no more than 15 to 20 grams of fat or the dieter risks side effects such as urgent need to go to the bathroom, gas or loose stools.
Motivated dieters who are eating better and exercising can expect to drop a little more weight if they take the drug. The Alli label says that for every 5 pounds a person loses on his or her own, Alli will increase that loss by another 2 to 3 pounds. The medication costs between $50 to $70, depending on the pill count of the package.
Orlistat is sold in a larger dose by prescription as Xenical by Roche Holding AG.