DEA-classified ‘safe’ pain med might be riskier than you think

By John Murphy, MDLinx
Published July 17, 2019

Key Takeaways

The opioid drug tramadol is classified as safer and less addictive than other common opioids like oxycodone and hydrocodone. Yet, patients prescribed tramadol postoperatively have a somewhat higher risk of prolonged use than patients given the other opioids, Mayo Clinic researchers reported in an article in The BMJ.

“We found that people who got tramadol were just as likely as people who got hydrocodone or oxycodone to continue using opioids past the point where their surgery pain would have been expected to be resolved,” said senior author Molly Jeffery, PhD, scientific director, Division of Emergency Medicine Research, Mayo Clinic, Rochester, MN. “This doesn’t tie to the idea that tramadol is less habit forming than other opioids.”

The Drug Enforcement Agency classifies tramadol as a Schedule IV substance—a drug with a low potential for abuse and a low risk of dependence. Oxycodone and hydrocodone are Schedule II controlled substances—dangerous drugs with a high potential for abuse that could lead to severe dependence.

Due to the opioid crisis, some physicians have reduced the number of pills in each opioid prescription, or they prescribe non-opioid pain medicine instead. Meanwhile, tramadol has become one of the most commonly prescribed opioids in the United States, often for treating acute pain after surgery. This upsurge is likely due to physicians’ perception that tramadol is safer and less addictive than other short-acting opioids, the researchers speculated.

However, the Centers for Disease Control unexpectedly reported that many patients who were prescribed tramadol for acute pain were still using the drug 1 year later, and some patients were still taking it up to 3 years later.

It was this news that prompted the Mayo Clinic researchers to begin their own investigation.

Greater risk with tramadol

For this observational study, the researchers reviewed administrative claims data from patients nationwide who underwent 20 common surgeries between January 2009 and June 2018, and found that 357,884 had filled a prescription for opioids after surgery.

Of these patients:

  • 7% had at least one opioid refill 90-180 days after surgery (which the researchers defined as “additional use”)
  • 1% refilled their prescription 180-270 days after surgery (defined as “persistent use”)
  • 0.5% had 10 or more prescription fills or ≥ 120 days’ supply (defined as “long-term use”)

In all three categories, patients were more likely to be prescribed tramadol than another short-acting opioid: 6% more likely for “additional use” patients, 47% more likely for “persistent use” patients, and 41% more likely for patients on “long-term use.”

The researchers wrote: “Our study suggests that tramadol carries a similar or somewhat greater risk of transitioning from acute to prolonged use compared with other short-acting opioids.”

Reschedule tramadol?

“Given that tramadol is not as tightly regulated as other short-acting opioids, these findings warrant attention,” said lead author Cornelius Thiels, DO, general surgery resident, Mayo Clinic School of Graduate Medical Education.

“This data will force us to reevaluate our postsurgical prescribing guidelines,” he added. “And while tramadol may still be an acceptable option for some patients, our data suggests we should be as cautious with tramadol as we are with other short-acting opioids.”

Dr. Thiels and coauthors concluded: “[F]rom the standpoint of opioid dependence, the Drug Enforcement Administration and FDA should consider rescheduling tramadol to a level that better reflects its risks of prolonged use.”

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