The Drug Enforcement Administration (DEA) has officially declared tramadol as a Class IV substance, including its salts, isomers, and salts of isomers. This new scheduling will go into effect August 18, 2014.
Tramadol is a centrally acting opioid analgesic that was initially approved in 1995 under the brand name Ultram (Janssen). It is a racemic mixture, where the (+) enantiomer is involved with binding to the mu opioid receptor and inhibition of reuptake of serotonin, while the (-) enantiomer is responsible for preventing the reuptake of norepinephrine.
In September 2010, the DEA was presented with a scientific and medical evaluation, along with a scheduling recommendation. After assessment of tramadol’s abuse potential, legitimate medical use, and dependence liability the Assistant Secretary of the HHS recommended that tramadol be scheduled as a Class IV substance. The final decision was supported by the following factors:
- Tramadol has a low potential for abuse relative to the drugs or substances in schedule III. The abuse potential of tramadol is comparable to the schedule IV controlled substance propoxyphene;
- Tramadol has a currently accepted medical use in treatment in the U.S. Tramadol and other tramadol-containing products are approved for marketing by the FDA to manage moderate to moderately severe pain; and,
- Abuse of tramadol may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.
As of the effective date, manufacturers will be required to print “C-IV” on the labeling of commercial containers of tramadol.
For more information visit DEA.gov.