Coming Soon: OTC Solution for Weight Loss

According to the National Institutes of Health, approximately 65% of adults in the United States are considered to be overweight or obese.¹ For many individuals, a potential weight-loss solution soon may be found in their local pharmacies, without the need for a prescription.

Conditional Approval

In April 2006, the FDA announced that GlaxoSmithKline had received conditional approval to market a nonprescription-strength version of Xenical (orlistat) under the brand name Alli. No definite date has been announced as to when the drug will receive its final approval. When it is approved, Alli will be the first FDAapproved weight-loss medication available without a prescription and will be half the strength of the prescription version distributed by Roche.

Alli will be available as 60-mg capsules to help individuals lose weight by blocking fat absorption in the small intestine. GlaxoSmithKline estimates that the use of Alli will cost patients approximately $12 to $25 per week. According to the manufacturer's recommendation, Alli should be used by overweight but not obese adults in conjunction with a diet reduced in fat and calories.

Counseling Patients

Pharmacists can play a fundamental role in providing patients with essential counseling information with regard to the proper use of this product and identifying potential contraindications. This counseling is especially important for some diabetic patients or for patients taking drugs such as cyclosporine or warfarin. Patients with gallbladder problems or those with chronic malabsorption disorders should not use orlistat.

Prior to recommending the use of this product, pharmacists should do the following:

• Determine whether the patient has a history of allergies to any medications
• Determine whether the patient is currently taking any other medications for weight loss management
• Review the patient's concurrent medication profile and medical history
• Determine whether the patient is or is planning to become pregnant
• Determine whether the patient has any history of eating disorders

Orlistat is to be taken 3 times a day along with main meals that contain fat or at least 1 hour after a meal. Because the use of orlistat can interfere with an individual's absorption of some fat-soluble vitamins, patients should be encouraged to take a daily multivitamin supplement that contains the fat-soluble vitamins. The multivitamin supplement should be taken at least 2 hours before or after taking orlistat.

Patients also should be informed of the potential side effects associated with the use of orlistat, which can include headache; oily spotting; gastrointestinal distress; flatulence with discharge; fatty, oily stool; and increased defecation. Patients also should be reminded that the weight-loss effects of the agent are diminished if the drug is discontinued. Most importantly, patients should understand that taking this drug is only one step to achieving their desired weight-loss goal. The drug should be taken in combination with a diet of reduced fat and calories, with no more than 30% of calories from fat. It also is important to include a regular exercise regimen as part of any weight-loss plan.

With more and more drugs becoming available over the counter, pharmacists are the best resource for patients to ensure that these drugs are taken safely and appropriately according to the manufacturer's recommendations.

Ms. Terrie is a clinical pharmacy writer based in Haymarket,Va.

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