WC500169468
WC500169468
WC500169468
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
A 60-day timetable was recommended for the assessment of this review leading to a further<br />
PRAC recommendation.<br />
4.1.3. Quetiapine (NAP)<br />
<br />
Signal of possible misuse and abuse<br />
Regulatory details:<br />
PRAC Rapporteur: Sabine Straus (NL)<br />
Administrative details:<br />
EPITT 17960 – New signal<br />
MAH(s): AstraZeneca, various<br />
Leading MS: NL<br />
Background<br />
Quetiapine is an atypical antipsychotic agent used in the treatment of schizophrenia and bipolar<br />
disorder (both manic and depressive episodes). A pharmaceutical form of extended release quetiapine<br />
is also indicated as add-on treatment of major depressive episodes in major depressive disorder<br />
(MDD).<br />
The exposure for nationally authorised medicines containing quetiapine is estimated to have been more<br />
than 36 million patients worldwide, in the period from first authorisation in 1997 until 2013.<br />
A signal of possible misuse and abuse was identified by the EMA following communication with the<br />
European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and an analysis conducted on<br />
EudraVigilance. NL, the Reference Member State for nationally authorised medicines containing<br />
quetiapine (originator) confirmed that the signal needed initial analysis and prioritisation by the PRAC.<br />
Discussion<br />
The PRAC discussed the information on the suspected cases reported and noted that literature data<br />
suggested there might be a divergent risk between abuse in poly-drug users - who may use quetiapine<br />
to counteract the effect of other substances that are used and drug-seeking behaviour – and in<br />
psychiatric patients seeking a higher dose for its sedative effects to counteract symptoms of insomnia<br />
and agitation (misuse). The PRAC agreed that it was useful to further review the evidence available<br />
and to require more information.<br />
The PRAC appointed Sabine Straus (NL) as Rapporteur for the signal.<br />
Summary of recommendation(s)<br />
<br />
<br />
The MAH for Seroquel (quetiapine) should provide to the PRAC Rapporteur in the next PSUR<br />
(DLP 31/07/2014) answers to a list of questions including a cumulative review of the reports of<br />
misuse and abuse and exposure data for both the immediate release (IR) and the extended<br />
release (XR) formulations.<br />
The PRAC Rapporteur will inform the PRAC of the conclusion of this review.<br />
4.1.4. Temozolomide – TEMODAL (CAP)<br />
<br />
Signal of diabetes insipidus<br />
Regulatory details:<br />
PRAC Rapporteur: Martin Huber (DE)<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/324055/2014 Page 17/73
Change language