In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
Based on its analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing paroxetine, the Pharmacovigilance Risk Assessment Committee (PRAC) reached the following conclusions.
In view of the available data on leukopenia from clinical trials, the literature, and spontaneous reports, as well as a case with a positive de-challenge and/or a case with a positive re-challenge, the PRAC considers that a causal relationship between the use of paroxetine and leukopenia is at least possible. The PRAC concluded that the instructions for medical use of medicinal products containing paroxetine should be amended accordingly.
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) agrees with the scientific conclusions drawn by PRAC.
Based on the scientific conclusions on paroxetine, the CMDh considers that the benefit/risk balance of medicinal products containing paroxetine does not change, provided that the proposed changes are made to the instructions for medical use.
Changes to be made to the relevant sections of the instruction for medical use (new text underlined and in bold).
“Adverse reactions” section
The following adverse reaction should be added to the subsection “Blood and lymphatic system disorders” with the frequency “uncommon”:
Leukopenia
Changes to the safety information on paroxetine-containing medicinal products based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 28–31 August 2023
The European Medicines Agency (EMA) has published the minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of 28–31 August 2023. Following the meeting, a decision was made on the need to introduce safety-related changes to the registration materials/instructions for medical use of medicinal products containing paroxetine.
Paroxetine (paroxetine) – PSUSA/00002319/202212
General information
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder, social anxiety disorder/social phobia, generalized anxiety disorder, post-traumatic stress disorder, and premenstrual dysphoric disorder.
Based on the evaluation of the PSUR, PRAC reviewed the benefit/risk balance of medicinal products containing paroxetine and made the following recommendations.
Summary of recommendations and conclusions
- Based on the analysis of safety and efficacy data, the benefit/risk balance of the use of medicinal products containing paroxetine for the approved indications remains unchanged.
- Nevertheless, the instructions for medical use should be updated by adding leukopenia as an adverse reaction with the frequency “uncommon”. Thus, the existing provisions of the instructions for medical use must be amended1.
- In the next PSUR, the registration certificate holder of medicinal products containing paroxetine (paroxetine) must submit cumulative reviews of cases of cough and interstitial lung diseases, including data from clinical studies, the post-registration period, and the literature, and also discuss whether an update of the instructions for medical use of the medicinal product is warranted.
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1 Update of the “Adverse reactions” section of the instructions for medical use. The risk assessment report and PRAC recommendation are forwarded to the CMDh for a decision.
List of medicinal products containing paroxetine (paroxetine) and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 22.11.2023)
To analyze the published information, the applicant must use the original text available at the link:
