By Pat Anson, PNN Editor
Patients recovering from surgery who take the opioid tramadol have a slightly higher risk of prolonged use than those receiving oxycodone or other short acting opioids, according to a large Mayo Clinic study.
Prescriptions for tramadol – which is sold under the brand names Ultram and ConZip – have been increasing because it is widely perceived as a “safer” opioid with less rick of addiction. The new study, published in The BMJ, appears to debunk that claim, at least for surgery patients.
Mayo Clinic researchers looked at health data for over 350,000 patients who were prescribed opioids after undergoing 20 common surgeries in the U.S. between 2009 and 2018. A little over 7% of the patients were still refilling opioid prescriptions 90-180 days later. When the researchers dug a little deeper into the data, they found that patients taking tramadol had a 6 percent higher risk of prolonged use compared to other opioids.
"This data will force us to reevaluate our postsurgical prescribing guidelines," says lead author Cornelius Thiels, DO, a general surgery resident in Mayo Clinic School of Graduate Medical Education. "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."
Tramadol is a synthetic opioid that was classified as a Schedule IV controlled substance by the Drug Enforcement Administration in 2014, a category that means it has a low potential for abuse. That same year, hydrocodone was rescheduled as a Schedule II drug, meaning it has a high potential for abuse.
Many patients who were taking hydrocodone were switched to tramadol as a result of the rescheduling.
Over half (53%) of the patients in the Mayo Clinic study were prescribed hydrocodone, about a third (37.5%) received oxycodone (also a Schedule II drug) , and only 4% received tramadol.
"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, the scientific director of research for the Mayo Clinic Division of Emergency Medicine. "This doesn't tie to the idea that tramadol is less habit forming than other opioids."
Jeffery and his colleagues say the DEA and FDA should consider reclassifying tramadol to a level that better reflects the risk of prolonged use.
"Given that tramadol is not as tightly regulated as other short-acting opioids, these findings warrant attention," said Thiels.
In 2017, the FDA banned the use of tramadol in children under the age of 12, citing a handful of cases where children died or had serious breathing problems after using the drug.
Tramadol was classified as a Schedule 3 drug in the United Kingdom in 2014. It is an unscheduled drug in Canada, but Health Canada is currently reviewing its status.