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Erste Hinweise: Selincro Nalmefene hat in siebzehn Fällen zu Suizidgedanken und Depressionen geführt.
Erfreuliches: Vom Tag der Zulassung 2013 bis Februar 2015 wurden weltweit lediglich 12.167 Patienten behandelt.
See P. 19 : 4.1.6. Nalmefene - SELINCRO (CAP)
Applicant: H. Lundbeck A/S
PRAC Rapporteur: Martin Huber
Scope: Signal of suicidal ideation
EPITT 18333 – New signal
Lead Member State: DE
Background
Nalmefene is an opioid system modulator indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms and who do not require immediate detoxification.
The post-marketing exposure for Selincro, a centrally authorised medicine containing nalmefene, is estimated to have been more than 12,167 patient-years worldwide, in the period from first authorisation in 2013 until February 2015.
During routine signal detection activities, a signal of suicidal ideation was identified by the EMA, based on seventeen cases retrieved from EudraVigilance and reported as being important medical events. The Rapporteur confirmed that the signal needed initial analysis and prioritisation by the PRAC.
Discussion
The PRAC discussed the available evidence from case reports in EudraVigilance. As there are cases in support of a potential causal relationship (including two reports describing a positive re-challenge) and considering that suicidal ideation is a serious event, the PRAC agreed to request the MAH for Selincro to submit a cumulative review of cases of depression and suicide/self-injury associated with nalmefene within the ongoing PSUR procedure.
Summary of recommendation(s)
The MAH for Selincro (nalmefene) should submit to the EMA, by 12 August 2015 within the ongoing PSUR procedure (DLP: 24/02/2015) (PSUSA/00010120/201502) a cumulative review of cases of depression and suicide/self-injury associated with nalmefene. The MAH should include data from all sources including clinical trials, spontaneous reports and relevant literature evaluating the biological plausibility for a possible association. Different drop-out rates should be taken into account when interpreting results from clinical trials. The MAH should also discuss the need for any potential amendments to the product information and/or the risk management plan as applicable.
Es gibt noch eine PDF-Datei (PN an mich): Pharmacovigilance Risk Assessment Committee (PRAC)
Minutes of the meeting on 08-11 June 2015 PN an mich. Darin sind alle UAW's aufgeführt.
LG Federico
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