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