It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months. Table 2: Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patientsĭrug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated * Sections or subsections omitted from the full prescribing information are not listed. Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope ( 5.9).įULL PRESCRIBING INFORMATION: CONTENTS * WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORSĢ.2 Depressive Episodes Associated with Bipolar I DisorderĢ.4 Dose Modifications for Renal ImpairmentĢ.5 Dose Modifications for Hepatic ImpairmentĢ.6 Dose Modifications Due to Drug Interactions of CYP3A4 Inhibitors and CYP3A4 Inducersĥ.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosisĥ.2 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patientsĥ.3 Cerebrovascular Adverse Reactions, Including Stroke in Elderly Patients with Dementia-Related Psychosisĥ.8 Leukopenia, Neutropenia and Agranulocytosisĥ.12 Potential for Cognitive and Motor Impairmentĥ.16 Neurological Adverse Reactions in Patients with Parkinson's Disease or Dementia with Lewy Bodiesħ.1 Drugs Having Clinically Important Interactions with LATUDAħ.2 Drugs Having No Clinically Important Interactions with LATUDAġ3.1 Carcinogenesis, Mutagenesis, Impairment of Fertilityġ4.2 Depressive Episodes Associated with Bipolar I Disorder. Consider discontinuing LATUDA if a clinically significant decline in WBC occurs in the absence of other causative factors ( 5.8). Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia or neutropenia.Hyperprolactinemia: Prolactin elevations may occur ( 5.7).
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