Endoxifen Approval for Bipolar Disorder in India: A Premature or a Pragmatic Decision?

In a commentary published in the Journal of Clinical Psychopharmacology, Dr. Rishab Gupta (Brigham and Women's Hospital/Harvard Medical School) and Dr. Swarndeep Singh (Government Medical College and Hospital, Chandigarh, India) cast a critical eye on India's regulatory approval for the use of endoxifen for the treatment of manic episodes in patients with bipolar disorder type 1. In their article and in this podcast, they suggest that there are important deficiencies in the research that was used to support the regulatory approval. No other country has approved endoxifen for treating bipolar disorder. They caution that endoxifen should be considered as an option to treat acute mania only after a careful consideration of risks/benefits with the patient and their family and after providing them with a list of alternative medications.