title: Postmarketing surveillance of abuse liability of sibutramine.
abstract: The abuse liability of medications is a growing concern as the number of newly approved psychoactive medications increases. Postmarketing surveillance can assist in determining abuse liability, but strategies are not well-defined for medications believed to be at low abuse risk. Using a newly approved medication (sibutramine--an anorectic drug), a novel approach to postmarketing abuse surveillance was introduced. A one-page anonymous questionnaire covering sibutramine, a scheduled anorectic drug (phentermine), and a fabricated name was added to the intake process of 58 treatment programs. From the 8780 completed questionnaires, 8.8% had heard of sibutramine and phentermine. For continued use to get high (a proxy for abuse), the rate for sibutramine was lower than for phentermine (0.6 vs. 2.2%, McNemar's chi(2) = 110.45, P < 0.001) but was higher than for the fabricated name (0.6 vs. 0.3%, McNemar's chi(2) = 11.86, P < 0.001). These results suggest the risk of abuse associated with sibutramine was lower than that associated with a known abused drug, one that itself is considered low risk despite decades of population exposure. The relatively high rate of hearing of sibutramine may be due to the direct-to-consumer advertisement. This approach is only one indicator in a surveillance framework but appears promising and validates findings from laboratory-based abuse liability studies that also indicate low abuse liability for sibutramine.
authors.affiliation: Department of Psychiatry and Behavioral Neurosciences, Addiction Research Institute, Wayne State University, 2761 E Jefferson, Detroit, MI 48207, USA. carfken@med.wayne.edu
authors.forename: Cynthia L
authors.initials: CL
authors.lastname: Arfken
authors.forename: Charles R
authors.initials: CR
authors.lastname: Schuster
authors.forename: Chris-Ellyn
authors.initials: CE
authors.lastname: Johanson
mesh_terms: D000328:Adult; D001067:Appetite Depressants; D003503:Cyclobutanes; D005260:Female; D006801:Humans; D008297:Male; D010645:Phentermine; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D016320:Substance Abuse Treatment Centers; D019966:Substance-Related Disorders / Q000453:epidemiology* / Q000517:prevention & control; D011795:Surveys and Questionnaires
chemical_list: D001067:Appetite Depressants; D003503:Cyclobutanes; D010645:Phentermine; C058254:sibutramine