Adverse reactions reported in clinical study1
- The most common adverse events reported in the clinical trials of ZONALTA were headache, vomiting, insomnia. Other side effects were: gastritis, epigastric discomfort, diarrhoea, restlessness, somnolence etc.
- Reduction in platelet count was observed in divalproex arm but not in ZONALTA.
- Blood thyroid stimulating hormone levels increased in 2 patients in divalproex arm compared to no such event in the ZONALTA arm.
- There were no deaths, serious or significant adverse events during the conduct of trials.
- Overall, ZONALTA was found to be well tolerated and safe in patients of Bipolar I disorder with acute mania episodes with or without mixed features.
References
- 1. Ahmad A, Sheikh S, Khan MA, Chaturvedi A, Patel P, Patel R, et al. Endoxifen: A New, Protein Kinase C inhibitor to treat acute and mixed mania associated with bipolar I disorder. Bipolar Disord. 2020 Dec 25. doi: 10.1111/bdi.13041. Epub ahead of print.