摘要：Abuse of widely available, over-the-counter drugs and supplements such as laxatives and diet pills for weight control by youths is well documented in the epidemiological literature. Many such products are not medically recommended for healthy weight control or are especially susceptible to abuse, and their misuse can result in serious health consequences. We analyzed the government’s role in regulating these products to protect public health. We examined federal and state regulatory authority, and referred to international examples to inform our analysis. Several legal interventions are indicated to protect youths, including increased warnings and restrictions on access through behind-the-counter placement or age verification. We suggest future directions for governments internationally to address this pervasive public health problem. Abuse of widely available, over-the-counter (OTC) drugs and supplements such as laxatives and diet pills by adolescents and adults for weight control is well documented as a national problem in the United States in the epidemiological literature. 1,2 Many of these products are not medically recommended for healthy weight control or are ineffective for weight loss, even in the short term. 1,3–5 Abuse of these products affects both males and females of all racial, ethnic, and socioeconomic groups. 1,6 The National Comorbidity Survey Replication, a nationally representative study of US households, found that 50% of people with bulimia nervosa, a disorder often associated with abuse of laxatives and diet pills, develop the illness by age 18 years. 7 Among US adolescents, 6% of girls and 4% of boys reported past-month use of diet products without physician advice. 2 Serious health consequences can result from abuse of these OTC products, such as acute and chronic impairment of gastrointestinal and cardiovascular systems, sometimes resulting in death. 8 Adverse effects include dehydration, chronic diarrhea and constipation, metabolic acidosis, hypokalemia, and other fluid and electrolyte disorders; cardiac arrhythmia; hemorrhagic and ischemic stroke; and hepatic and renal failure. 3,4,9–12 Products and product categories that have been widely abused for weight control include those explicitly marketed for such purposes, but also other products only believed to aid in weight control, including laxatives and syrup of ipecac. 9,13,14 OTC laxatives are medically approved to treat constipation, but have received a fair amount of attention in the epidemiological and medical literatures because of their prevalence of abuse. Based on their review of more than 70 studies, Neims et al. estimated the lifetime prevalence of laxative abuse for weight control to be 4% of the general US population, affecting many millions of Americans. 15 Estimates of the lifetime prevalence of laxative abuse from studies of patients diagnosed with bulimia nervosa or eating disorders not otherwise specified have ranged from 15% to as much as 62%. 16 In a large, community-based sample of adolescents, past-year use of laxatives for weight control purposes was estimated to be 2% in girls and 1% in boys. 6 In 2007, the US Food and Drug Administration (FDA) approved the first nonprescription diet drug, orlistat, for OTC status. Orlistat is a weight-loss drug that prevents the absorption of fat from food and has a laxative-like effect. 17 Prescription strength orlistat was approved at 120 milligrams in 1999 for obesity management, and in 2007, the FDA approved orlistat 60 milligrams for OTC status under the name alli. Concerns about potential misuse and abuse of orlistat were raised by eating disorder experts upon its OTC approval 18 and continue to be raised globally as the drug becomes more accessible internationally. 19 Studies are emerging to support these concerns. A study with a clinical sample of patients with eating disorders found that 6% misused alli, most often in an effort to compensate for a binge eating episode. 20 Despite the ineffectiveness and potential harm of many products used and misused for weight control, the global market for diet management and weight loss products was estimated to be $363 billion in 2009 and is projected to reach $586 billion by 2014. 21 In addition, the sale of products not overtly marketed for weight loss but abused for weight control generates millions of dollars each year. In 2008, total sales of OTC laxatives in the US approached $290 million. 22 It is significant that OTC laxatives are substantially less expensive than alli, and thousands of pills can be purchased for a fraction of the price of alli. 23,24 Both drug products are widely available in retail establishments, pharmacies, and on the Internet, and both are advertised directly to consumers, with the manufacturer of alli employing a celebrity spokesperson in its advertisements. 25 In light of the epidemiological evidence documenting the abuse of OTC laxatives and the increasing concerns over potential misuse of alli, we obtained a pilot grant to examine current US regulations pertinent to these 2 OTC drug products. We analyzed the US government’s legal authority to increase regulation to address outstanding public health concerns. Available legal methods include requiring warning labels and regulating permissible locations where such products may be sold. We thus analyzed federal and state regulatory authority and looked to specific international examples of countries with known regulation of diet products to inform our analysis and provide context for the consideration of alternative restrictions. We have set forth this research and provided recommendations for increased regulations. Definitions of Terms Relating to Drug Dispensation Term Definition BTC Behind the counter of any retail establishment (no pharmacist required to be on the premises) BTC pharmacy Behind the counter of pharmacies only (requiring contact with pharmacy staff) OTC Over-the-counter of any retail establishment (not requiring prescription or contact with pharmacy staff) OTC pharmacy Over-the-counter in pharmacies only but not requiring contact with a pharmacist Prescription Requires physician prescription (only available in pharmacies and requiring contact with pharmacy staff to obtain drug) Retail establishment Place that sells over-the-counter products Pharmacy Place that sells over-the-counter products and prescription-only products; also called drug stores Open in a separate window
