The Diversion of Ultram®, Ultracet®, and Generic Tramadol HCl

Abstract

Ultram® (tramadol HCl) was approved by the Food and Drug Administration in 1994 as a non-scheduled drug under the Controlled Substance Act. The non-scheduled status was contingent on the development and implementation of a comprehensive postmarketing surveillance program by an Independent Steering Committee external to Ortho-McNeil Pharmaceutical charged with monitoring abuse and recommending scheduling if unexpectedly high abuse occurred. The program developed by this committee was composed of a variety of studies, and the results of the first three years of the surveillance efforts revealed that the rate of Ultram abuse was low. At a meeting of the FDA in 1998 to reexamine the scheduling status of Ultram, it was recommended that the scope of the postmarketing surveillance program be broadened to include data on diversion. After one year pilot study, by January 2002, a nationwide diversion survey was fully operational. This brief communication describes the experiences of this diversion study, and compares the findings on the diversion of Ultram and other tramadol HCl products with that of more widely abused drugs. Survey data suggest that the diversion of Ultram and other tramadol products is low, and overall, diversion investigators did not consider tramadol to be a problem in their respective jurisdictions.