A sweeping new analysis has cast serious doubt on the safety and efficacy of tramadol, the world's most commonly prescribed opioid painkiller. The research concludes the drug provides only clinically insignificant pain relief while more than doubling a patient's risk of experiencing serious and potentially deadly side effects, particularly cardiovascular events.
Decades of Prescriptions Based on Flawed Belief
For nearly five decades, doctors have prescribed tramadol for moderate to severe chronic pain, partly due to a long-held clinical belief that it carried a lower addiction potential than stronger opioids like oxycodone or fentanyl. This perception of relative safety fuelled its widespread use, with the United States alone seeing over 16 million prescriptions in 2023.
However, researchers in Denmark have now conducted a comprehensive review of past clinical trials, challenging this established practice. Their analysis, published in the BMJ, examined 19 studies involving more than 6,500 people who took either tramadol or a placebo.
Negligible Benefits Versus Significant Harms
The findings were stark. The researchers stated that 'tramadol may have a slight effect on reducing chronic pain (low certainty of evidence) while likely increasing the risk of both serious… and non-serious adverse events.' Crucially, they concluded that 'the potential harms associated with tramadol use for pain management likely outweigh its limited benefits.'
Compared to a placebo, patients taking tramadol had 113% higher odds – more than double – of experiencing any serious adverse event. This increased risk was 'mainly driven by a higher proportion of cardiac events and neoplasms [tumours].' The 'cardiac events' category included documented incidents of myocardial infarction (heart attack), chest pain, and congestive heart failure.
A Dangerous Overlap for Vulnerable Patients
The demographics of tramadol use make these cardiac risks especially concerning. The drug is frequently prescribed to older adults suffering from chronic pain conditions like osteoarthritis and nerve pain. The average age of participants in the reviewed studies was 58, placing them squarely in the high-risk demographic for cardiovascular disease.
While no precise data tracks tramadol use specifically in heart patients, the significant demographic overlap suggests many people with underlying, perhaps undiagnosed, heart conditions are likely being exposed to the drug. For them, tramadol may act as a triggering or exacerbating factor for a cardiac event.
The common side effects reported in the studies also included nausea, dizziness, and constipation. Like all opiates, tramadol also carries a risk of addiction, though it is classified as Schedule IV in the US, indicating a lower abuse potential than some other opioids.
Call for a Clinical Rethink on Pain Management
The researchers stopped short of calling for regulatory bodies to revoke the drug's approval. Instead, they urged doctors to 'reconsider' prescribing it and to substitute it with 'safer alternatives.' They pointed clinicians towards options such as non-opioid pain relievers and drug-free therapies including specific physical therapies and cognitive behavioural therapy.
This new evidence places physicians in an even more challenging position amid the ongoing opioid crisis, caught between the pressure to curb opioid prescriptions and the duty to manage genuine, debilitating patient suffering. The study fundamentally challenges tramadol's reputation as a 'safer' opioid and suggests that for chronic pain management, its risks may far outweigh its meagre benefits.
