The Ministry of Health of the Russian Federation recommended owners and manufacturers of eight antidepressants to introduce changes to the instructions. This is reported by PhV with reference to the letter of the Ministry of Health placed in the State Register of Medicines (GRLS).
This concerns the following drugs: Citalopram, Escitalopram, Fluoxetine, Milnacipran, Fluvoxamine, Paroxetine, Sertraline, and Venlafaxine.
The Federal State Budgetary Institution “Research Center for Expert Examination of Products Used for Healthcare Purposes” of the Ministry of Health informed the department about the need for uniformity in drug instructions by.
“Roszdravnadzor (Federal Service for Surveillance in Healthcare) has received information about the risk of postpartum bleeding associated with the use of antidepressants of the group of Selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and Serotonin and norepinephrine reuptake inhibitors (SNRIs) by pregnant women,” the letter says.
It is necessary to amend three sections in the instructions: “Use during pregnancy and breastfeeding”, “Side effects”, “Special instructions”.
According to the document, the information is based on data from the Pharmacovigilance Risk Assessment Committee of the European Regulator (PRAC EMA).
As it became known in March, the demand for antidepressants has sharply increased in Russia.
