Saphris Warnings and Precautions

Specific Precautions and Warnings With Saphris

Warnings and precautions to be aware of prior to taking Saphris include the following:
  • Saphris can cause life-threatening allergic reactions. Signs and symptoms of such reactions might include:
    • Wheezing and/or difficulty breathing
    • Swelling of the mouth, tongue, or throat
    • Rash
    • Low blood pressure (hypotension)
    • Fast heart rate (tachycardia).
Seek emergency medical attention if you think you may be having a serious reaction to this medication.
  • The U.S. Food and Drug Administration (FDA) has issued a special warning (called a "black box warning") about the use of atypical antipsychotic medications like Saphris 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 were not treated with those medications.
Studies also suggest that such medications may increase the risk of strokes or transient ischemic attacks (TIAs) in elderly people with dementia. Saphris is not approved to treat dementia in the elderly, and caution should be used before prescribing this drug in such cases. 
  • Saphris can cause a change in the heart rhythm known as QT prolongation. QT prolongation can lead to life-threatening arrhythmias, including torsade de pointes. Thus, it should not be combined with other medications that can prolong the QT interval (see Saphris Drug Interactions). You may be at a higher risk for this problem if you have:
    • An electrolyte imbalance, such as low potassium or magnesium levels
    • An arrhythmia
    • Severe heart failure
    • A recent history of heart attack
    • Long QT syndrome
    • A slow heart rate.
  • This drug can cause a life-threatening condition called neuroleptic malignant syndrome (NMS). Some symptoms of NMS include:
    • A high fever
    • Stiff muscles
    • Confusion
    • Irregular pulse or blood pressure
    • A fast heart rate (tachycardia)
    • Sweating
    • Irregular heart rhythms (arrhythmias).
Contact your healthcare provider right away if think you might have NMS.
  • Saphris can cause weight gain. For most people, this increase will be quite small (between two and four pounds, on average); however, some people may gain enormous amounts of weight. Because weight gain is associated with health problems, your healthcare provider should monitor your weight while you are taking Saphris.
  • This medication can cause tardive dyskinesia, which is a condition involving unusual, uncontrollable body or face movements. The condition can become permanent even if Saphris 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 Saphris.
  • Saphris 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, breast discharge, absent menstrual periods, or impotence (also known as erectile dysfunction, or ED).
  • Antipsychotic medications may sometimes cause low white blood cells, a problem that can lead to dangerous infections or other serious problems.
  • Atypical antipsychotics can cause an increase in blood sugar levels and can increase the risk of developing diabetes. However, this did not seem to be a significant problem in studies of Saphris, with less than 1 percent of people experiencing such problems.
Nonetheless, be sure to tell your healthcare provider if you develop signs of diabetes, such as increased thirst, urination, and hunger. If you have diabetes, your blood sugar should be monitored carefully and regularly during treatment with Saphris to make sure the condition is not becoming more severe.
  • Saphris 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, Saphris should be used with caution 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 Saphris may be more likely to develop heat stroke. Be careful to stay hydrated and avoid overheating while taking this drug.
  • Saphris can cause difficulty swallowing, which could lead to inhalation of food and, in some cases, pneumonia. Tell your healthcare provider if you notice any problems with swallowing during treatment.
  • Make sure you know how this medicine affects you before driving or operating heavy machinery, as it may cause drowsiness or other problems that can interfere with your ability to perform such tasks.
  • Saphris is considered a pregnancy Category C medication. This means that it may not be safe to take during pregnancy. Talk with your healthcare provider about the risks and benefits of using this drug when pregnant (see Saphris and Pregnancy).
  • It is unknown if Saphris passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider before beginning treatment (see Saphris and Breastfeeding for more information).
  • In general, alcohol should be avoided while taking Saphris.
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Saphris Medication Information

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