Mood, Personality, and Behavior Changes During Treatment with Statins: A Case Series

Area of Science:

• Pharmacovigilance
• Neuropsychiatry
• Cardiovascular Pharmacology

Background:

• Psychiatric adverse drug reactions (ADRs) associated with statin use are reported, yet literature on mood and behavioral changes remains limited.
• Central nervous system and behavioral effects linked to cholesterol-lowering drugs require further characterization.

Purpose of the Study:

• To gather information on the natural history and characteristics of central nervous system/behavioral changes associated with statin use.
• To explore potential mechanisms underlying statin-associated mood and behavioral alterations.

Main Methods:

• A survey was administered to individuals (and/or proxies) reporting mood/behavioral changes linked to statins.
• Data collected included drug history, effect characteristics, time-course, co-occurring ADRs, and causality assessment using Naranjo criteria.

Main Results:

• Twelve participants reported mood/behavior changes (e.g., irritability, depression, violent ideation, suicide) linked to statin initiation.
• Effects resolved upon drug discontinuation and recurred with rechallenge in some cases.
• Eight participants met criteria for probable or definite causality; several cases involved risk factors and co-occurring statin ADRs.

Conclusions:

• Statin use may precipitate adverse mood and behavioral changes in susceptible individuals.
• These findings expand on limited literature and support further research into statin-associated neuropsychiatric ADRs.
• Potential mechanisms, including oxidative stress and bioenergetic pathways, warrant investigation.