The Food and Drug Administration has approved only a few prescription drugs for weight loss, primarily appetite suppressants, such as sibutramine, phentermine, phendimetrazine and diethylpropion. The FDA removed some appetite suppressants from the market because of potentially life-threatening side effects that include increased blood pressure and heart rate. Xenical is effective and safe with a different mechanism of action, but also has unpleasant side effects.
Indication
The FDA approved Xenical as a new molecular entity in 1999. Xenical contains orlistat, the active pharmaceutical ingredient, in 120-mg capsules to be taken orally. According to the product label, Xenical is for obesity management including weight loss when used in conjunction with a reduced calorie diet, to reduce the risk of weight regain after weight loss and for obese patients with an initial body mass index equal to or above 30 or equal to or above 27 in the presence of other risk factors, such as diabetes, high blood pressure and high cholesterol and fats. Body mass index, BMI, is a measurement of your weight and height, and can indicate your body fatness and be used to screen for health troubles associated with weight. The higher your BMI, the greater your risks of obesity, diabetes, cardiovascular disease and other conditions.
Features
Orlistat inhibits your fat enzymes, blocking one-third of the amount of fat you ingest from foods from being digested in your stomach and absorbed through your intestines into your body. As a result, you absorb fewer calories from your meals. The undigested fat goes through your intestinal tract and out of your body. This can cause some undesirable side effects that include smelly gas, oily stools and sudden, uncontrollable need for a bowel movement.
Effectiveness
The recommended dosage of Xenical is one 120-mg capsule three times daily with meals containing fat. Clinical trials demonstrate that Xenical causes weight loss in as little as two weeks and continues for more than a year. Results from five clinical trials demonstrated that patients taking Xenical for six months have a mean weight loss of 12.4 lbs, and patients taking Xenical for 12 months have a mean weight loss of 13.4 lbs. Of patients who completed one year of treatment with Xenical, 57 percent lost at least 5 percent of weight. Of patients who completed two years of treatment with Xenical, 40 percent lost at least 5 percent of weight.
Considerations
Taking Xenical may increase your risk of deficiencies of fat soluble vitamins, such as vitamins A, D, E and K. Taking vitamin supplements two hours before or after meals may help to replenish them. Even with vitamin supplements, some people who take orlistat, particularly adolescents, have reduced vitamin D concentrations, according to research by scientists at the National Institute of Child Health and Human Development and published in "Pharmacotherapy" in 2002. Consult your doctor, pharmacist or dietitian about your diet, taking supplements and monitoring your vitamin D levels when prescribed Xenical.
References
- National Institute of Diabetes and Digestive and Kidney Diseases: Prescription Medications for the Treatment of Obesity
- Tribune Media Services: Only 3 Prescription Weight-Loss Drugs Are Approved by the FDA
- Food and Drug administration: FDA Approved Drug Products
- Genentech: Xenical Prescribing Information
- Centers For Disease Control and Prevention: Healthy Weight - It's Not a Diet, It's a Lifestyle!
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