© 2022 MJH Life Sciences and Pharmacy Times. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmacy Times. All rights reserved.
The Drug Enforcement Administration has officially placed tramadol, a centrally acting opioid analgesic, into schedule IV of the Controlled Substances Act.
As of August 18, 2014, the Drug Enforcement Administration (DEA) has officially placed tramadol, a centrally acting opioid analgesic, into schedule IV of the Controlled Substances Act.
In the past, it was widely believed that tramadol had a better safety profile than other opioid analgesics. Now that the drug has been deemed a Schedule IV substance, however, health care professionals may be less likely to prescribe it to patients for pain.
Within the first 2 years of the drug’s approval for use in the United States, between 2 to 3 patients out of every 100,000 were abusing tramadol, experts found. Researchers also discovered that patients were susceptible to suffering from opioid-like withdrawal symptoms after stopping tramadol treatment. In fact, 40% of the adverse effects associated with tramadol are linked to discontinuation of the painkiller.
In 2010 alone, more than 16,000 visits to the emergency room were documented as resulting from the use of tramadol for non-medial purposes.
This past June, the United Kingdom decided to place tramadol under strict restrictions. Several states have been implementing laws of their own to schedule tramadol as a controlled substance. As a result, the level of exposure to the drug has dropped in those areas.
Now that the DEA has stepped in, there is potential for the amount of tramadol exposure to decrease across the nation as a whole.
“As confirmed by the association, current distributors of tramadol are DEA registrants with existing controlled substance storage that complies with DEA regulations,” the agency explained in its declaration. “The DEA understands that handlers of tramadol may need to make modifications to their current security procedures for compliance. These modifications necessary for security compliance will be a 1-time modification to provide for the appropriate storage, revision of operating procedures, training of staff, and amendments to suspicious order monitoring systems to include customer verifications.”