Risk Analysis of Lurasidone in Patients with Schizophrenia and Bipolar Depression.

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.