One of the world’s most widely used opioid pain relievers, tramadol, offers limited benefits for pain and may significantly increase the risk of serious cardiovascular events, a recent study shows.
Tramadol has been prescribed for nearly five decades for moderate to severe chronic pain and is considered less addictive than strong opioids such as oxycodone or fentanyl. In the United States, more than 16 million prescriptions were registered in 2023 alone.
Researchers in Denmark analyzed 19 clinical trials involving more than 6,500 people, comparing tramadol with a placebo. The results show that the drug provides only a slight reduction in chronic pain and doubles the risk of serious adverse events. These include chest pain, coronary heart disease and congestive heart failure, but also more common side effects such as nausea, dizziness and constipation.
“Tramadol may have a mild effect on chronic pain reduction (low-certainty of evidence), but probably increases the risk for both serious and less serious adverse events“, note the authors of the study, according to the Daily Mail. “The potential harms associated with the use of tramadol for pain management probably outweigh the limited benefits“.
A commonly prescribed but risky drug
Tramadol can be administered both in hospital and at home as an outpatient treatment. Although it has a lower risk of addiction than stronger opioids, it does exist and should be considered. The study highlights the difficulty for doctors to find a completely safe opioid for pain relief, caught between the pressure to limit prescriptions and the responsibility to help patients in pain.
Participants in the analyzed studies were, on average, 58 years old, an age group at high risk for heart disease. The researchers argue that tramadol could trigger or worsen these problems, especially since many chronic pain patients are also elderly people at cardiovascular risk.
Of the 19 studies reviewed, five looked at neuropathic pain, nine at osteoarthritis, four at chronic low back pain and one at fibromyalgia. The analysis showed that the increased risk of serious adverse events is mainly driven by a higher proportion of heart disease and tumors. Compared to placebo, patients taking tramadol were 113% more likely to experience a serious adverse event.
Researchers’ recommendations
Although the study does not suggest withdrawing the drug from the market, the authors recommend that doctors “reconsider” tramadol prescriptions and replace it with safer alternatives such as non-opioid pain relievers or drug-free therapies such as specific physiotherapy and cognitive behavioral therapy.
The study was published in the British Medical Journal (BMJ) and raises serious questions about the safety of tramadol, a drug previously considered more “sure” in the context of the opioid crisis.
