FAQ
Nonprescription Orlistat (Alli®): A New Weight Loss Option
Obesity is an important public health in the United States, with an estimated 66% of Americans classified as being overweight or obese. The prevalence of obesity has continued to increase since the 1970s, and recent statistics reveal that 31% of the population is currently obese. This news is especially alarming considering the association of obesity with a number of diseases including hypertension, type 2 diabetes, dyslipidemia, cardiovascular disease, osteoarthritis, and various cancers. Although diet and exercise remain the staple management options for weight management, pharmacotherapeutic agents are an option for some patients. Currently, sibutramine (Meridia®) and prescription strength Orlistat (Xenical®) are the only 2 agents FDA-approved for weight management. Generally, these agents are only recommended for patients with a body mass index (BMI) of > 30 kg/m2 or > 27 kg/m2 in the presence of concomitant obesity-related risks or diseases. The most recent development in weight management is the availability of Alli, a nonprescription orlistat product. Orlistat was first approved as a prescription weight loss agent in 1999, with the recommended dosage of 120 mg 3 times daily with meals.
How does orlistat work to promote weight loss?
The drug is not systemically absorbed and works as an inhibitor of pancreatic and gastric lipases, enzymes are necessary for the breakdown of fats into absorbable fatty acids and monoglycerides. At recommended prescription doses (120 mg), orlistat can inhibit up to 30% of ingested fat from absorption in the gastrointestinal tract; at nonprescription doses (60 mg) approximately 25% of dietary fat is not absorbed. Orlistat has been the subject of many clinical studies and its safety record is well established.
Who should take nonprescription orlistat?
Nonprescription orlistat can be considered for weight loss in overweight and obese adults over the age of 18 with a BMI of > 27 kg/m2. For adolescents between the ages of 12 and 18 years, orlistat is available by prescription only. Orlistat should be used in combination with exercise and a low fat diet.
Who should not take nonprescription orlistat?
Nonprescription orlistat is not recommended for patients taking cyclosporine or those receiving other immunosuppressant agents for organ transplant. Patients who have malabsorption syndromes, eating disorders, gallstones or kidney stones, or pancreatitis should not use orlistat. Patients who are not overweight or those who are pregnant or breastfeeding should not use orlistat. Diabetic patients, patients with hypothyroidism, and those receiving warfarin require monitoring and should use orlistat only with the advice of a physician.
How should orlistat be used?
The recommended dose of nonprescription orlistat is 60 mg (1 capsule) with each fat-containing meal up to three times daily. Although the prescription strength dose is 120 mg, the lower dose is recommended to limit the severity of gastrointestinal side effects. If a meal is missed or contains no fat, the orlistat dose may be omitted. If a dose is missed, orlistat may be taken up to 1 hour after a meal or the dose may be omitted. It is recommended that patients take a daily multivitamin at bedtime to avoid vitamin deficiency due to the reduced absorption of fat-soluble vitamins. Patients should be counseled that dramatic weight loss with orlistat alone is unlikely.
How much weight loss should patients anticipate with nonprescription orlistat?
Onset of weight loss is generally seen within 2 weeks of therapy and maximum weight loss often occurs around 6 months. In clinical studies of mildly obese individuals (BMIs of 25 to 28 kg/m2) with orlistat 60 mg, mean weight loss was 1.6 kg after 4 months of treatment. In patients with baseline BMIs ranging from 28 to 43 kg/m2, pooled study data reveal that 42% of patients receiving orlistat 60 mg achieved weight loss of ≥ 5% after 6 months of treatment (average weight loss 2.3 kg).
What adverse effects may occur?
Adverse reactions associated with orlistat are primarily gastrointestinal in nature and are commonly observed in the early months of treatment. Gastrointestinal reactions may be exacerbated by eating meals high in fat, and it is generally recommended to avoid meals with greater than 30% fat content. Gastrointestinal side effects include abdominal discomfort, bloating, flatulence, increased frequency and urgency of bowel movements, diarrhea, oily or fatty stools, and fecal incontinence. According to the manufacturer, studies have noted that the 60 mg dosage has fewer GI-related adverse effects compared to the 120 mg dosage; more patients discontinued treatment early due to adverse effects with the 120 mg dosage (5.4%) compared to the 60 mg dosage (3.2%)
GlaxoSmithKline, in response to FDA concerns and in anticipation of consumer inquiries, has developed a special consumer information starter kit for Alli. The starter kit contains a quick facts card, companion guide, healthy eating guide, fat and calorie counter, daily journal, and an optional free 12 month behavioral program accessible at: www.myalli.com. As compared to prescription strength Xenical®, nonprescription Alli® costs significantly less (approximately $63 per month for the Alli® starter pack).
In conclusion, patients must understand that there are no quick fixes or “magic bullets” for weight loss. Although nonprescription orlistat provides a relatively safe and effective companion to lifestyle changes including daily exercise and healthy eating, patients must be educated on proper use of this medication. In order to help consumers make informed choices about starting and proper use of this medication, pharmacists should be familiar with orlistat including dosing and administration, adverse effects and interactions. Pharmacists and other health care professionals must assess the individual needs of each consumer before making recommendations.
References:
National Heart, Lung, and Blood Institute. The practical guide: identification, evaluation, and treatment of overweight and obesity in adults. Available at: http://www.nhlbi.nih.gov/guidelines/obesity/ob-home.htm. Accessed June 20, 2007.
U.S. Food and Drug Administration. Joint meeting of the nonprescription drugs advisory committee and endocrinologic and metabolic drugs advisory committee. Available at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4201B1_01_GSK-Brief.pdf. Accessed June 18, 2007.
GlaxoSmithKline. Alli. Available at: www.myalli.com. Accessed June 20, 2007.
OTC orlistat (Alli) for weight loss: an update. Pharmacist's Letter/Prescriber's Letter 2007;23(7):220702.