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Precautions and Warnings With Lurasidone

Lurasidone may increase your risk of developing a life-threatening condition called neuroleptic malignant syndrome, which can include symptoms such as a high fever and stiff muscles. Extra caution should be used when treating elderly people with dementia or people who have a history of seizures. Understanding lurasidone's warnings and precautions can help ensure a safe treatment process.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking lurasidone hydrochloride (Latuda®) if you have:
Also, let your healthcare provider know if you:
  • Are pregnant or thinking of becoming pregnant
  • Are breastfeeding
  • Drink alcohol.
You should also tell your healthcare provider about all of the medications you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Lurasidone Precautions and Warnings

Some warnings and precautions to be aware of prior to taking lurasidone include the following:
  • The U.S. Food and Drug Administration (FDA) has issued a special warning (a "black box warning") about the use of atypical antipsychotic medications (including lurasidone) in elderly people with dementia, such as Alzheimer's disease. Elderly people with dementia who are treated with atypical antipsychotics are more likely to die of various causes than those who are not treated with them.
Studies also suggest that such medications may increase the risk of strokes or transient ischemic attacks (TIAs) in elderly people with dementia. Lurasidone is not approved to treat dementia in the elderly, and caution should be used before giving it to elderly people with dementia.
  • Lurasidone can cause a life-threatening condition called neuroleptic malignant syndrome (NMS). Some symptoms of NMS include:
    • High fever
    • Stiff muscles
    • Confusion
    • Irregular pulse or blood pressure
    • Fast heart rate (tachycardia)
    • Sweating
    • Irregular heart rhythms (arrhythmias).
Tell your healthcare provider right away if think you might have NMS.
  • Lurasidone can cause tardive dyskinesia. This is a condition involving unusual, uncontrollable body or facial movements. The condition can become permanent, even if lurasidone is stopped. The best way to prevent it from becoming permanent is to tell your healthcare provider right away if you notice any abnormal movements (including abnormal movements of the tongue) while taking lurasidone.
  • Antipsychotics can cause an increase in blood sugar levels and can increase the risk of developing diabetes. Tell your healthcare provider if you develop signs of diabetes while taking lurasidone, such as increased thirst, increased urination, or hunger.
If you have diabetes, your blood sugar should be monitored carefully and regularly during treatment with lurasidone to make sure your condition is not becoming more severe.
  • Lurasidone can increase the level of the hormone prolactin. Tell your healthcare provider if you have signs of high prolactin levels, such as breast enlargement, breast pain, or breast discharge.
  • Antipsychotics have been reported to cause undesirable changes in cholesterol or triglyceride levels. Weight gain has also been reported (see Latuda and Weight Gain).
  • Antipsychotic medications may sometimes cause low white blood cells, a problem that can lead to dangerous infections or other serious problems.
  • Even though lurasidone is not classified as an antidepressant, the U.S. Food and Drug Administration (FDA) has required lurasidone to carry the special antidepressant and suicide warning, since lurasidone is used to treat bipolar depression. Antidepressants may increase the risk of suicidal thinking or behavior in children, teenagers, and adults (see Depression and Suicide for more information). Therefore, if you notice any changes in symptoms or new symptoms, talk to your healthcare provider right away.
    Some of these symptoms may include:
    • Anxiety
    • Hostility
    • Agitation
    • Panic
    • Restlessness
    • Hallucinations
    • Extreme hyperactivity
    • Suicidal thinking or behavior.
  • Lurasidone can cause a drop in blood pressure when going from a sitting or lying-down position to standing (known medically as orthostatic hypotension). This can cause a person to have lightheadedness or dizziness, or to faint.
Tell your healthcare provider if you have any of these symptoms when standing. Orthostatic hypotension can be especially dangerous in people with heart disease or congestive heart failure (CHF).
  • Like all antipsychotic medications, lurasidone should be used cautiously in people with epilepsy or a history of seizures, or with other medical conditions, such as Alzheimer's disease, which may increase the risk of seizures.
  • People who take lurasidone may be more likely to develop heat stroke. Be careful to stay hydrated and avoid overheating.
  • Lurasidone can cause difficultly swallowing, which can lead to inhalation of food and can cause pneumonia. Tell your healthcare provider if you notice any problems swallowing.
  • Make sure you know how lurasidone affects you before driving or operating heavy machinery, as the medication may cause drowsiness or other problems.
  • Lurasidone is considered a pregnancy Category B medication. This means that it is probably safe to take during pregnancy, although the full risks are currently unknown. Talk with your healthcare provider about the risks and benefits of using lurasidone when pregnant (see Latuda and Pregnancy).
  • It is unknown if lurasidone passes through breast milk. Therefore, if you are breastfeeding or plan to start, talk with your healthcare provider about using this drug (see Latuda and Breastfeeding for more information).
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