IMPORTANT SAFETY INFORMATION FOR LATUDA
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly people with dementia-related psychosis (a severe mental health problem) taking atypical antipsychotic drugs, including LATUDA, are at an increased risk for death compared with those taking placebo (sugar tablet). LATUDA is not approved for the treatment of people with dementia-related psychosis (see BOXED WARNING). An increased risk for stroke and ministroke has been reported in elderly people with dementia-related psychosis.
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Neuroleptic malignant syndrome (NMS): NMS is a rare and potentially fatal side effect reported with LATUDA and similar medicines. Call your healthcare provider right away if you have high fever; stiff muscles; confusion; changes in pulse, heart rate, or blood pressure; sweating; or muscle pain and weakness. Treatment should be stopped if you have NMS.
Tardive dyskinesia (TD): TD is a serious and sometimes permanent side effect reported with LATUDA and similar medicines. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk for developing TD and the chance that it will become permanent is thought to increase the longer a person takes the medicine and the more medicine a person takes over time. TD can develop after a person has been taking the medicine for a short time at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if the person stops taking the medicine.
Metabolic Changes
High blood sugar: High blood sugar and diabetes have been reported with LATUDA. If you have diabetes or risk factors for diabetes, such as being overweight or a family history of diabetes, your blood sugar should be tested at the beginning of and throughout treatment with LATUDA. Complications of diabetes can be serious and even life threatening. Tell your healthcare provider if you have blood sugar problems or signs of diabetes, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry.
High cholesterol and triglycerides: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
Weight gain: Some patients may gain weight while taking LATUDA. Your healthcare provider should check your weight regularly. Talk to your healthcare provider about ways to help control your weight, such as eating a healthy, balanced diet and exercising.
Additional Important Warnings
- Light-headedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting position has been reported with LATUDA.
- Low white blood cell counts and related conditions have been reported with LATUDA and similar medicines. Tell your healthcare provider if you have or had low white blood cell counts.
- LATUDA and medicines like it may raise the levels of prolactin. Tell your healthcare provider if you experience a lack of menstrual periods, leaking or enlarged breasts, or impotence.
- Tell your healthcare provider if you have a seizure disorder, have had seizures in the past, or have conditions that increase your risk for seizures.
- Tell your healthcare provider if you experience prolonged, abnormal muscle spasm or contraction, which may be signs of a condition called dystonia.
- LATUDA can affect your judgment, thinking, and motor skills. You should not drive or operate hazardous machinery until you know how LATUDA affects you.
- LATUDA may make you more sensitive to heat. You may have trouble cooling off. Be careful when exercising or when doing things likely to cause dehydration or make you warm.
- The symptoms of schizophrenia may include thoughts of suicide or of hurting yourself or others. If you have these thoughts at any time, tell your healthcare provider or go to an emergency room right away.
- LATUDA and medicines like it have been associated with swallowing problems. If you have had or have swallowing problems, you should tell your healthcare provider.
Pregnancy: Tell your healthcare provider if you are pregnant or if you are planning to get pregnant while taking LATUDA. Breast feeding is not recommended during treatment with LATUDA.
Tell your healthcare provider about all prescription and over-the-counter medicines you are taking or plan to take, since there are some risks for drug interactions with LATUDA. Avoid drinking alcohol while taking LATUDA.
In people with schizophrenia, the most common side effects that occurred with LATUDA were sleepiness, an inner sense of restlessness or need to move (akathisia), movement abnormalities such as tremors, slow movement, or muscle stiffness (parkinsonism), upset stomach, and agitation.
This is not a complete summary of safety information. Please discuss the full Prescribing Information for prescription LATUDA with your healthcare provider.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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