Title:Risk Analysis of Lurasidone in Patients with Schizophrenia and Bipolar Depression
Volume: 19
Issue: 2
Author(s): Harika Modugula and Anoop Kumar*
Affiliation:
- Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research, Raebareli (NIPER-R), Lucknow (UP) -226002,India
Keywords:
Lurasidone, adverse drug reactions, schizophrenia, bipolar disorder, depression, dystonia.
Abstract: Lurasidone was approved by the United States Food and Drug Administration (FDA) for
the treatment of schizophrenia, as well as for the treatment of bipolar depression. However, emerging
reports have indicated various adverse drug reactions with the use of lurasidone. Thus, in this article,
we have analyzed the risk profile of lurasidone in the established therapeutic indication. A total of 419
studies were published from October 2010-July 2019 regarding lurasidone. After the inclusion and exclusion
criteria, 17 studies were selected for the analysis of risk. The adverse drug reactions (ADRs) of
these studies were categorized as per the innovator summary of product characteristics (SmPC). Finally,
the unlisted ADRs were analyzed by using the Naranjo probability algorithm. Telogen effluvium,
thrombocytopenia, restless leg syndrome and hypersexuality were found with the use of lurasidone
and fall under the unlisted category. The causality assessment has shown a probable correlation of
lurasidone with hypersexuality, restless leg syndrome, thrombocytopenia and possible relation with
telogen effluvium. In conclusion, lurasidone is a novel and efficacious pharmacological treatment for
bipolar depression and schizophrenia. However, more data regarding the safety of this drug in a large
population is needed.
