News Brief: Public Citizen Seeks Tighter Restrictions on Opioid Tramadol

The opioid tramadol (CONZIP, ULTRACET, ULTRAM) should be moved to a more restrictive classification of controlled substances because it is overprescribed, often misused, highly addictive and potentially deadly, Public Citizen said in a Nov. 6, 2019, petition to the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA).[1]

Tramadol was first marketed in the U.S. in 1995 and is approved by the FDA for use in adults for the management of severe pain for which alternative non-opioid treatments are inadequate. It was not even categorized as a controlled substance for 20 years in the U.S. before finally being placed in the weakly controlled schedule IV under the Controlled Substances Act in 2014. Schedule IV drugs are those considered to have a low potential for abuse and a low risk of dependence.

Placing tramadol in schedule IV is one of the many factors contributing to the ongoing opioid overdose epidemic, Public Citizen told the agencies. The epidemic claimed nearly 400,000 lives from 1999 to 2017.

Since 2014, evidence has accumulated showing that tramadol poses significant public health risks similar to the more tightly controlled schedule II opioids. It has become one of the most commonly prescribed opioids in the U.S. and, according to government health studies, was misused by more than 1.5 million people in 2018.

Unlike those opioids appropriately placed under the weaker restrictions of schedule IV, controlled substances in schedule II are known to have a high potential for misuse. They include fentanyl, hydrocodone and oxycodone. Under this schedule, much tighter restrictions on prescribing drugs are imposed to prevent misuse and abuse. Public Citizen urged the DEA and FDA to reschedule tramadol expeditiously to schedule II.

Public Citizen’s Health Research Group has designated tramadol as Do Not Use because unlike other opioids, it can cause seizures.
 

References

[1] Public Citizen. Citizen petition to the Drug Enforcement Administration and the Food and Drug Administration to Reschedule Tramadol from Schedule IV to Schedule II. November 6, 2019. https://www.citizen.org/wp-content/uploads/2497.pdf. Accessed November 10, 2019.