Balls Hen House Pharmacy

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Volume 5, Issue 10

FDA Approves Alli™ (orlistat 60mg capsules) Over-the-Counter
Contributed by: Derek Blau, Pharm.D. Candidate
                      KU School of Pharmacy

April 2007

What is Alli™?
Alli ™, also referred to by its generic name orlistat, is the only FDA approved over-the- counter medication for weight loss.  Previously orlistat was only available by prescription from a physician under the tradename of Xenical™ at a dosage of 120mg.  The strength approved for over-the-counter use is 60mg.  Alli™ is more than just a pill, it is a weight loss program which combines medication along with a comprehensive support program.  The Alli™ package will include companion guides, a guide to healthy eating, a daily journal, a calorie and fat counter, quick fact cards, and free access to an individualized online action plan.  Alli™ was approved for over-the-counter use in February 2007 and is expected to be available this summer.

Who should take Alli™?

  • Alli™ is indicated for weight loss in adults 18 years or older when used along with a reduced calorie, low fat diet
  • Alli™ is for people who:
  • are considerably overweight with a Body Mass Index (BMI) > 30
  • have a BMI > 27 and other risk factors such as high blood pressure, high cholesterol, heart disease, or diabetes

How does it work?
Unlike other weight loss agents, which work in the brain to suppress appetite or increase metabolism, Alli™ works in your digestive system to block the fat in the food you eat from being digested.  Alli™ to lipases, digestive enzymes which help breakdown fat, inhibiting the enzymes from breaking down some of the fat you've eaten.  The undigested fat can not be absorbed and is eliminated in you bowel movements.


How do I take it?
The recommended daily dose of Alli™ is one 60mg capsule three times a day with meals.  Alli™ must be used in conjunction with a reduced calorie, low fat diet containing approximately 15 grams of fat per meal.

What are the side effects associated with Alli™?

  • The most common side effects associated with Alli™ are:
  • Headache
  • Gas with oily spotting
  • Flatulence
  • More frequent stools
  • Fecal incontinence or difficulty controlling bowel movements
  • Stomach upset
  • Loss of fat soluble vitamins (replace by taking multivitamin)
**Adverse events increase when eating meals containing > 15 grams of fat


What should I do before I start taking Alli™?
Before you start taking Alli™ you should consult your healthcare provider to determine if it is appropriate for you.  If you have any questions or would like more information about Alli™, you can ask your local pharmacist or go to www.myalli.com.

Co-edited by:
Sarah Hare, Pharm.D.
Miranda Wilhelm, Pharm.D.

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