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Tapentadol – Risk of Seizures & Serotonin Syndrome

Following an EU-wide review of safety data and spontaneous reports of serious adverse events, European & UK regulators have strengthened warnings about the risks of both seizures and serotonin syndrome associated with the tramadol-like opioid tapentadol.

Regulators have provided the following advice for Healthcare Professionals:

  • tapentadol, like all opioid medicines, can induce seizures
  • tapentadol should be prescribed with care in patients with a history of seizure disorders or epilepsy
  • tapentadol may increase seizure risk in patients taking other medicines that lower seizure threshold, for example, antidepressants such as SSRIs, SNRIs & TCAs, and antipsychotics
  • serotonin syndrome has been reported whentapentadol is used in combination with serotoninergic antidepressants
  • withdrawal of the serotoninergic medicine, together with supportive symptomatic care, usually brings about a rapid improvement in serotonin syndrome