PRAC June 2022 –Update of COVID-19 vaccins and new safety information for Xalkori.
June 20, 2022
During its June 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is continuing its assessment of cases of heavy menstrual bleeding (heavy periods) with the COVID-19 mRNA vaccines and the PRAC finds no link between mRNA COVID-19 vaccines and absence of menstruation. The PRAC also discussed a direct healthcare professional communication (DHPC) containing important safety information for Xalkori.
Update on review of cases of heavy menstrual bleeding with mRNA COVID-19 vaccines
The PRAC is continuing its assessment of cases of heavy menstrual bleeding (heavy periods) with the COVID-19 mRNA vaccines Comirnaty and Spikevax.
PRAC finds no link between mRNA COVID-19 vaccines and absence of menstruation
The PRAC concluded that there was insufficient evidence to establish a causal association between the COVID-19 vaccines Comirnaty and Spikevax and cases of absence of menstruation (amenorrhoea).
Xalkori: risk of ocular toxicity and severe visual loss in paediatric patients
As part of its advice on safety-related aspects to other EMA committees, the PRAC discussed a direct healthcare professional communications (DHPCs) containing important information for Xalkori. This DHPC informs healthcare professionals of the risk of ocular toxicity, severe visual loss and the need for monitoring in paediatric patients with Xalkori.