PRAC November 2022 – Measures for Janus kinase inhibitors, modified product information of mRNA COVID-19 vaccines Comirnaty and Spikevax, and addition of warning to the product information for ustekinumab (Stelara)
November 21, 2022
During its November 2022 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders. Furthermore, the PRAC recommended to add heavy menstrual bleeding to the product information as a side effect of the mRNA COVID-19 vaccines Comirnaty and Spikevax, and to add a warning to the product information for ustekinumab (Stelara).
Source: FAMHP
Janus kinase (JAK) inhibitors: measures to minimise the risk of serious side effects
The Pharmacovigilance Risk Assessment Committee (PRAC) recommends measures to minimise the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. These side effects include cardiovascular conditions, blood clots, cancer and serious infections.
Comirnaty and Spikevax : heavy menstrual bleeding added as a side effect
The PRAC recommends that heavy menstrual bleeding should be added to the product information as a side effect of unknown frequency of the mRNA COVID-19 vaccines Comirnaty and Spikevax.
Ustekinumab (Stelara) : warning on use of live vaccines in infants whose mothers received ustekinumab during pregnancy
The PRAC recommendes adding a warning to the product information for ustekinumab (Stelara) on the use of live vaccines in infants whose mothers received ustekinumab during their pregnancy.