Vraylar - What are some of the important warnings?
Vraylar may cause serious side effects including the increased risk of death in elderly people with dementia related psychosis, and the increased risk of suicidal thoughts or actions in children and young adults.
What is Vraylar used to treat?
- Vraylar is used for the treatment of schizophrenia in adults.
- Vraylar is used for the short-term (acute) treatment of manic or mixed episodes associated with bipolar I disorder (bipolar mania) in adults.
- Vraylar is used for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults.
- Vraylar is also used as an add-on (adjunct) treatment to antidepressants in adults with major depressive disorder.
Vraylar warnings include:
- Increased risk of death and cerebrovascular adverse reactions (e.g. stroke, transient ischemic attack) in older adults with dementia-related psychosis
- Increased risk of suicidal thoughts or actions in children and young adults.
Patients and caregivers should be made aware of the onset of suicidal thoughts and behaviors, especially at the start of treatment, or when the dosage is adjusted up or down. Any new or sudden changes in mood, behaviors, thoughts, or feelings should be reported to a healthcare provider right away.
Symptoms of concern include:
- thoughts about suicide or dying
- new or worse depression
- feeling very agitated or restless
- trouble sleeping (insomnia)
- acting aggressive, being angry, or violent
- an extreme increase in activity and talking (mania)
- attempts to commit suicide
- new or worse anxiety
- panic attacks
- new or worse irritability
- acting on dangerous impulses
- other unusual changes in behavior or mood.
Other warnings and precautions for Vraylar include:
- neuroleptic malignant syndrome, a serious condition that can be fatal. Symptoms include fever; confusion; changes in breathing, heart rate, and blood pressure; stiff muscles; and increased sweating.
- tardive dyskinesia, a condition characterized by uncontrolled body movements in the face, tongue, or other body parts.
- late occurring side effects that may occur weeks after starting treatment or increasing the dose.
- metabolic changes such as high blood sugar, diabetes, weight gain, and elevated cholesterol and triglycerides.
- low white blood cell count (leukopenia, neutropenia, and agranulocytosis).
- orthostatic hypotension (decreased blood pressure) which may lead to fainting and falls.
- cognitive and motor impairment such as sleepiness, drowsiness, feeling tired, and difficulty thinking and doing normal activities.
- body temperature dysregulation making you feel too warm.
- dysphagia (difficulty swallowing) that can cause food or liquid to get into your lungs.
Common side effects reported in people treated for schizophrenia include extrapyramidal symptoms (involuntary movements) and akathisia (restlessness).
Common side effects reported people treated for bipolar depression include nausea, akathisia, restlessness, and extrapyramidal symptoms.
Common side effects reported in people treated for bipolar mania include extrapyramidal symptoms, akathisia, dyspepsia (indigestion), vomiting, somnolence (drowsiness), and restlessness.
Common side effects reported in people receiving Vraylar in addition to antidepressants for major depressive disorder include akathisia, restlessness, fatigue, constipation, nausea, insomnia, increased appetite, dizziness, and extrapyramidal symptoms.
- Food and Drug Administration. VRAYLAR Product Label. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204370s009lbl.pdf [Accessed December 22, 2022]
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