Tramadol is an opioid marketed for the relief of moderate to severe pain. It exposes patients to the adverse effects of opioids (intestinal, neuropsychological, and respiratory disorders, dependence and addiction, etc.), and to specific adverse effects, including hypoglycaemia and cardiac arrhythmia, with a risk of overdose in combination with other medicines or in some patients.

Tramadol became the best-selling opioid in France after dextropropoxyphene (combined with paracetamol) was withdrawn from the market due to its lethal risks. Tramadol is the analgesic most implicated in unintentional overdose. Tramadol, along with morphine, is the opioid most implicated in fatal accidental overdoses.

British and Korean epidemiological studies have shown greater mortality in patients exposed to tramadol than in controls, such as patients exposed to non-steroidal anti-inflammatory drugs (NSAIDs). In another British study, from 2004 to 2014, mortality attributed to tramadol use increased in parallel with tramadol use. In 2014, tramadol regulations were tightened, consumption decreased and so did mortality.

These studies have certain limitations that expose them to various biases but tend to suggest an increased risk of death related to tramadol. This confirms that when using a so-called weak opioid, despite wide differences in reputation and regulation, it is prudent to be at least as vigilant as with morphine.

Pain management must involve better use of non-pharmacological methods of pain relief and careful management of paracetamol and NSAID analgesics (ibuprofen, naproxen).

©Prescrire 1 June 2020

Source: "Tramadol: increased mortality?" Prescrire International 2020; 29 (216): 152-153. Subscribers only.

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