其 他 安 全 警 示
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| The United Kingdom: Tapentadol: risk of seizures and reports of serotonin syndrome when co-administered with other medicines (English Only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that tapentadol may increase seizure risk in patients taking other medicines that lower seizure threshold, for example, antidepressants and antipsychotics. Serotonin syndrome has also been reported when tapentadol is used in combination with serotoninergic antidepressants.
Tapentadol is an opioid analgesic. The risk of seizures is a recognised adverse reaction for all opioid medicines. However, a recent review of safety data for tapentadol in the EU identified the need for strengthened advice about the risk of seizures. Approximately half of the identified spontaneous reports of seizure reflected co-administration of tapentadol with at least one other drug known to lower seizure threshold. These medicines include selective serotonin-reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, and antipsychotics. Tapentadol should be used with care in patients with a history of seizure disorders or epilepsy because of the increased risk of seizures. Strengthened warnings on seizure risk have been added to the Summary of Product Characteristics and Patient Information Leaflets.
MHRA is also aware of reports of serotonin syndrome identified when tapentadol is co-administered with antidepressants, such as SSRIs, SNRIs, tricyclic antidepressants and antipsychotics. Serotonin syndrome is likely when one of the following is observed: spontaneous clonus; inducible or ocular clonus with agitation or diaphoresis (sweating); tremor and hyper-reflexia; hypertonia and body temperature higher than 38°C and inducible ocular clonus. Withdrawal of the serotoninergic medicine together with supportive symptomatic care, usually brings about a rapid improvement. The continued use of tapentadol must be evaluated on an ongoing basis. Withdrawal symptoms can occur with abrupt cessation of treatment.
Healthcare professionals are advised:
- as for all opioid medicines, tapentadol 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, tricyclic antidepressants, and antipsychotics
- serotonin syndrome has been reported when tapentadol 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
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/tapentadol-palexia-risk-of-seizures-and-reports-of-serotonin-syndrome-when-co-administered-with-other-medicines
In Hong Kong, there are 8 registered pharmaceutical products containing tapentadol, and all products are prescription-only medicines. So far, the Department of Health has not received any case of adverse drug reaction related to tapentadol. In light of the above MHRA’s announcement, letters to inform local healthcare professionals will be issued and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Thursday, Jan 10, 2019
Issued at HKT 15:00
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