Based on the evaluation of the analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing pitavastatin, the Pharmacovigilance Risk Assessment Committee (PRAC) made the following conclusions:
Angioedema
Based on post-marketing reports of angioedema with medicinal products containing pitavastatin, manifested as swelling of the face, lips, and oropharynx and laryngeal edema, some of which showed positive dynamics of the adverse reaction after drug withdrawal (37) and an adverse reaction on re-administration of the drug (3), PRAC established a possible causal relationship between pitavastatin and angioedema.
Therefore, PRAC recommends that registration certificate holders of medicinal products containing pitavastatin amend the section “Adverse reactions” of the instructions for medical use regarding:
- Angioedema with frequency “not known”.
Lupus-like syndrome
Taking into account the safety information presented that became known from the literature regarding other studies of statins in relation to lupus-like syndrome and information on other statins indicating a class effect of this adverse reaction, as well as data on cases with pitavastatin in the EudraVigilance database, PRAC considers a causal relationship between the use of medicinal products containing pitavastatin and lupus-like syndrome possible. PRAC recommends that registration certificate holders of medicinal products containing pitavastatin amend the section “Adverse reactions” of the instructions for medical use regarding:
- Lupus-like syndrome with frequency “not known”.
Gynecomastia
Based on reports of cases of gynecomastia in the post-registration period, two of which showed positive dynamics of the adverse reaction after withdrawal of the product containing pitavastatin and one of which had an adverse reaction upon re-administration of the product, with no alternative cause for this adverse reaction, the PRAC considers that there is a possible causal relationship between the use of medicinal products containing pitavastatin and gynecomastia. The PRAC recommends that registration certificate holders of medicinal products containing pitavastatin amend the “Adverse reactions” section of the instructions for medical use regarding:
- Gynecomastia with a frequency of “rare”.
List of medicinal products containing pitavastatin and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 31.03.2020). (31 KB) (Downloaded: 25.01.2021 08:42:50)
Linkhttps://www.ema.europa.eu/en/documents/psusa/pitavastatin-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable/00010502/201907_en.pdf
