Drug safety evaluation of aripiprazole in bipolar disorder

ABSTRACT

Introduction: Safety and tolerability of medications are key variables to inform treatment choice for patients with bipolar disorder (BD). This review focuses on the overall tolerability and safety profile of aripiprazole when used for its bipolar disorder indications, which include acute treatment of manic and mixed episodes and maintenance treatment of bipolar I disorder for the oral formulation, agitation associated with bipolar mania for the injectable immediate-release formulation, and maintenance treatment of bipolar I disorder for the long acting once-monthly (AOM) formulation.

Areas covered: The authors reviewed aripiprazole safety in bipolar disorder according to product labeling. English language reports located through PubMed and information available on the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) websites, with a focus on the safety and tolerability of aripiprazole, were reviewed.

Expert opinion: Compared to many other antipsychotics, aripiprazole has a relatively favorable tolerability profile, with a lower risk for weight gain, dyslipidemia, diabetes, and hyperprolactinemia. Compared to first-generation antipsychotics, and similar to most second-generation antipsychotics, aripiprazole has a reduced propensity for extrapyramidal side effects and a better cardiovascular safety.

KEYWORDS:

• Aripiprazole
• tolerability
• safety
• bipolar
• metabolic
• prolactin
• long acting
• weight
• pregnancy
• dyskinesia

Declaration of interest

A Cuomo is/has been a consultant and/or a speaker and/or has received research grants from Angelini, Apsen, Lundbeck, Otsuka. S Bolognesi is/has been a consultant and/or a speaker for Apsen. A Fagiolini is/has been a consultant and/or a speaker and/or has received research grants from Allergan, Angelini, Apsen, Boheringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Doc Generici, FB-Health, Italfarmaco, Janssen, Lundbeck, Mylan, Otsuka, Pfizer, Recordati, Sonofi Aventis, Sunovion and Vifor. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.