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Pharmacy and Medications

Is tramadol addictive?

06/24/2009

Question:

Is tramadol addictive?

Answer:

Evidence-based medicine suggests it is addictive and the extracts and quotes stated below verify this statement:

"Tramadol is a central-acting synthetic opioid with weak mu-opioid activity, and is approved for treatment of moderate to moderately severe pain in adults. Tramadol has a nonscheduled status under the Controlled Substance Act (CSA), which means tramadol has no substance abuse potential." (The term "abuse" herein denotes substance abuse or dependence.)

MedWatch has received 766 case reports of abuse associated with tramadol, as well as 482 cases of withdrawal associated with tramadol from the drug's initial U.S. marketing in 1995 through September 2004.

From 1995 to 2002, DAWN reported drug-related emergency department visits mentioning tramadol in more than 12,000 cases. Tramadol case numbers significantly increased 165% during this time.

The FDA's Drug Abuse Advisory Committee performed a formal review of the tramadol abuse evidence in 1998, including the data from Ortho-McNeil's surveillance studies and federal case reporting/surveillance programs. The FDA did not recommend changing tramadol's unscheduled status. The FDA's considered decision, to not schedule tramadol as a controlled substance, implies its abuse risk to the general population is low in comparison to its analgesic benefit.

In October 2005, the World Health Organization (WHO) sent an official request to the FDA of the United States to collect information on seven substances for the review of Dependence-Producing Psychoactive Substances. Tramadol was one of the substances on the list of seven products.

Submitted by Jennifer Prout
PharmD Candidate, The Ohio State University College of Pharmacy

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Response by:

The Ohio State University Carmen M Hadley, RPh, CSPI
Clinical Instructor
Central Ohio Poison Center
Nationwide Children’s Hospital
College of Pharmacy
The Ohio State University