"Feb. 22, 2011 -- The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.
Antipsychotic drugs are used to "...
Physicians are advised to discuss the following issues with patients for whom they prescribe FANAPT:
QT Interval Prolongation
Patients should be advised to consult their physician immediately if they feel faint, lose consciousness or have heart palpitations. Patients should be counseled not to take FANAPT with other drugs that cause QT interval prolongation [see WARNINGS AND PRECAUTIONS]. Patients should be told to inform physicians that they are taking FANAPT before any new drug is taken.
Neuroleptic Malignant Syndrome
Patients and caregivers should be counseled that a potentially fatal symptom complex sometimes referred to as NMS has been reported in association with administration of antipsychotic drugs, including FANAPT. Signs and symptoms of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia) [see WARNINGS AND PRECAUTIONS].
Patients should be aware of the symptoms of hyperglycemia (high blood sugar) and diabetes mellitus. Patients who are diagnosed with diabetes, those with risk factors for diabetes, or those who develop these symptoms during treatment should have their blood glucose monitored at the beginning of and periodically during treatment. Patients should be counseled that weight gain has occurred during treatment with FANAPT. Clinical monitoring of weight is recommended. [see WARNINGS AND PRECAUTIONS].
Interference with Cognitive and Motor Performance
Because FANAPT may have the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that FANAPT therapy does not affect them adversely [see WARNINGS AND PRECAUTIONS].
Advise patients that third trimester use of Fanapt may cause extrapyramidal and/or withdrawal symptoms in a neonate. Advise patients to notify their healthcare provider with known or suspected pregnancy [see Use In Specific Populations].
Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FANAPT during pregnancy [see Use In Specific Populations].
Advise women not to breastfeed during treatment with FANAPT [see Use In Specific Populations].
Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or overthe- counter drugs, since there is a potential for interactions [see DRUG INTERACTIONS].
Patients should be advised to avoid alcohol while taking FANAPT.
Heat Exposure And Dehydration
Patients should be advised regarding appropriate care in avoiding overheating and dehydration.
Last reviewed on RxList: 6/28/2016
This monograph has been modified to include the generic and brand name in many instances.
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