Subscription is FREE for qualified healthcare professionals in the US.

DEA Redesignates Tramadol Schedule IV Drug

July 23, 2014
Final ruling takes effect on August 18, 2014, and follows a year of hearings and comments.

The Drug Enforcement Administration (DEA) has officially changed tramadol from a non-classified drug to a schedule IV drug, effective August 18, 2014.1 First approved by the US Food and Drug Administration (FDA)  in 1995, tramadol (Ultram) is a centrally acting opioid analgesic. Since its approval, there has been debate over whether tramadol has the same potential for abuse as other opioids. In September 2010, the assistant secretary of the Health and Human Services provided the DEA with evidence suggestion the scheduling change.

Tramadol is metabolized via CYP2D6 to its active metabolite (O-desmethytramadol). When tramadol was first approved, its abuse potential was felt to be low because of its experience in Europe, where a risk of abuse rate was cited as 1.5 cases per 100,00 patients.2 However, after its approval (and growing concerns about abuse of other opioids), the FDA recommended that a strict independent post-marketing surveillance program be established and sponsored by the manufacturer of Ultram, Ortho-McNeil. According Medpage Today, the oft cited “monthly incidence of abuse was 2 to 3 cases per 100,00 patients in the first 2 years following its approval" was reported by the committee.3  Moreover, patient who abruptly stopped tramadol also underwent withdrawal symptoms similar to that of opioids.

The DEA noted that those supporting the change included a local muti-agency prescription drug-abuse task force, which described tramadol as “a ‘loop hole’ drug which is addictive, abused, and diverted.”1 By going from a non-controlled to controlled status, the DEA will ensure that tramadol “is subject to the same controls as other similarly addictive controlled substances.” Another commentator noted that although analgesics are addictive to a very small percentage of people that use them, “scheduling this drug would reduce the number of emergency room visits and number of overdose deaths,”1 which have reportedly increased dramatically over the last decade. Within the US, over 16,000 visits to the emergency department have been linked to tramadol in 2010.3

Moving from non-controlled to schedule IV status should not impact access to prescription to tramadol. The DEA noted that schedule IV controlled medications are, in fact, readily available for those with a valid prescription and appropriate medical condition. In addition, these types of prescriptions have the added convenience of being easily transferrable between pharmacies, phoned-in by prescribers, and refilled 5 times over a 6-month period.

Last updated on: May 19, 2015