Post-Marketing Surveillance of Statins—A Descriptive Analysis of Psychiatric Adverse Reactions in EudraVigilance

Abstract

Statins are included in the category of high-frequency prescription drugs, and their use is on an upward trend worldwide. In 2012, the FDA issued a warning about possible cognitive adverse drug reactions (ADRs) related to statins, some of which are listed in the Summary of Product Characteristics, but there are still concerns about their potential risk of psychiatric events. The aim of this research was to investigate spontaneous reports containing psychiatric ADRs associated with statins by analyzing the EudraVigilance (EV) database. From January 2004 to July 2021, a total of 8965 ADRs were reported for the Systems Organ Class (SOC) “psychiatric disorders”, of which 88.64% were registered for atorvastatin (3659), simvastatin (2326) and rosuvastatin (1962). Out of a total of 7947 individual case safety reports (ICSRs) of the 3 statins mentioned above, in 36.3% (2885) of them, statins were considered the only suspected drug, and in 42% (3338), no other co-administered drugs were mentioned. Moreover, insomnia has been reported in 19.3% (1536) of cases, being the most frequent adverse reaction. A disproportionality analysis of psychiatric ADRs was performed. The Reporting Odds Ratio (ROR) and 95% confidence interval (95% CI) were calculated for simvastatin, atorvastatin and rosuvastatin compared with antiplatelets and antihypertensive drugs. The reporting probability for most ADRs of these statins compared to antiplatelets was higher. The reporting probability for insomnia, nightmares and depression produced by statins compared to antihypertensive drugs was also higher. The results of this analysis augment the existing data about a possible correlation between the administration of statins and the occurrence of psychiatric side effects.

Glucagon-like Peptide-1 Receptor Agonists and Suicidal Ideation: Analysis of Real-Word Data Collected in the European Pharmacovigilance Database

“…Finally, other suspected and concomitant medicines reported in our ICSRs may have influenced the development of symptoms of suicidal behaviour. Statins, for example, have been associated with higher reporting of psychiatric adverse events in a previous pharmacovigilance study [ 41 ]. Proton pump inhibitors have also been investigated for their psychiatric effects, including suicidal ideation and depression [ 42 ].…”

A Descriptive Analysis of Direct Oral Anticoagulant Drugs Dosing Errors Based on Spontaneous Reports from the EudraVigilance Database

“…Subsequently, the number of “fatal” ADRs and “NR/NS” ADRs was noted for each evaluated PT since the date of the first report registered in EV. Causality and severity were not limiting criteria for the inclusion of ICSR in EV [ 65 ]. The Pearson correlation coefficient was calculated to evaluate the correlation between each category of ADRs (overdosing errors, underdosing errors, modified dose errors, fatal dosing errors, and NR/NS dosing errors) and total ADRs reported in EV.…”

“…The analysis was performed with MedCalc Software Ltd. Odds ratio calculator [ 65 ]; (accessed on 5 December 2022) (Version 20.123). Data extraction for the disproportionality analysis was performed on 3 December 2022.…”

Safety Profile of the Trastuzumab-Based ADCs: Analysis of Real-World Data Registered in EudraVigilance

“…To establish the disproportionate signal, reporting odds ratio (ROR) and 95% confidence intervals (CI) [34] were calculated with MedCalc Software Ltd. Odds ratio calculator [35]; https://www.medcalc.org/calc/odds_ratio.php (Version 20.123), accessed on 26 February 2024. EMA recommends that data from EV could be analyzed if ICSRs are classified into four categories and two dichotomous variables (a two-by-two contingency table) [36].…”