Tighter Restrictions Needed on Overprescribed Opioid, Public Citizen Tells DEA and FDA

Evidence Shows That Tramadol Is Overprescribed, Often Misused, Highly Addictive and Potentially Deadly

WASHINGTON, D.C. – An opioid that is used to treat severe pain in adults should be moved to a higher classification of controlled substances because it is overprescribed, often misused, highly addictive and potentially deadly, Public Citizen said today in a petition to the U.S. Drug Enforcement Administration (DEA) and the U.S. Food and Drug Administration (FDA).

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 with 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. According to the Centers for Disease Control and Prevention, 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 of 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 urges the DEA and FDA to reschedule tramadol expeditiously to schedule II.

“The failure to designate tramadol as a controlled substance when it was initially approved by the FDA and the subsequent placement of the drug in a less restrictive category has promoted the false belief that the drug must have a much better safety profile than other opioids,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “The dangerous misperception of tramadol’s safety has led to reckless overprescribing of the drug during the past several years of the opioid epidemic.”

Read the petition here.