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.
The Pharmacovigilance Risk Assessment Committee (PRAC), based on the analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing beta-alanine PSUSA/00010510/202301, reached the following conclusions.
In view of the available data on anaphylactic reactions from spontaneous reports, including 5 cases with a positive test of use and withdrawal (de-challenge) and 3 cases with a positive test of re-administration of the medicinal product (re-challenge), and in view of the probable mechanism of action, the PRAC considers that a causal relationship between the use of beta-alanine and an anaphylactic reaction is at least possible. The PRAC concluded that the instructions for medical use of medicinal products containing beta-alanine 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 regarding beta-alanine (beta-alanine), the CMDh considers that the benefit/risk balance of medicinal products containing beta-alanine (beta-alanine) remains unchanged, subject to the proposed amendments 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 “Immune system disorders” with the frequency “not known”:
Anaphylactic reaction
Changes to the safety information on medicinal products containing beta-alanine based on the results of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) held on 25–28 September 2023
The European Medicines Agency (EMA) has published the minutes of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) held on 25–28 September 2023. Following the meeting, it was decided that safety-related changes need to be made to the registration materials/instructions for medical use of medicinal products containing beta-alanine.
Beta-alanine (beta-alanine) – PSUSA/00010510/202301
Beta-alanine is an amino acid indicated for peripheral vasodilation as a non-hormonal inhibitor of menopause-related hot flushes.
Based on the PSUR assessment, PRAC reviewed the benefit/risk balance of medicinal products containing beta-alanine and provided 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 beta-alanine (beta-alanine), for the approved indications remains unchanged.
- Nevertheless, the package insert should be updated to add anaphylactic reaction as an adverse reaction with a frequency of “not known”. Accordingly, the existing provisions of the package insert should be amended1.
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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 CMDh for a decision.
List of medicinal products containing beta-alanine (beta-alanine) and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 07.12.2023)
To analyze the published information, the applicant must use the original text available at the link:
