Warnings & Recalls for Latuda
Black Box Warning
Latuda's risk involve older patients who have been diagnosed with dementia. In use with Latuda, these patients have an increased risk of death, severe loss of memory including the inability to perform daily activities, and a higher risk of stroke.
Patients on Latuda are advised to rise slow when in lying position as fast movements may cause dizziness or lightheadedness.
Before taking Latuda
, patients should tell their doctor if they have ever had a history of liver or kidney disease, heart disease, ever used street drugs, any chest pain, high or low blood pressure or heart rhythm problems, history of motion sickness, including a heart attack or stroke, have ever had high cholesterol or triglycerides, low white blood cell counts, irritable bowel syndrome, history of glaucoma, breast cancer or seizures, have ever had diabetes in the family, severe depression, or Parkinson's disease, any muscle weakness, any history of ulcers or urinary problems.
Patients who currently
have severe vomiting, diarrhea or signs of dehydration should tell their doctor of these symptoms.
Patients who are allergic
to Latuda or any of its ingredients (mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry, carnauba wax, yellow ferric oxide and FD&C Blue No.2 Aluminum Lake).
Doctors should be aware of any medications the patient is on including herbal medications, ketoconazole or rifampin.
Latuda can cause mild to sever drowsiness, therefore patients should be advised to not operate heavy machinery
until they are aware of the effects of this drug and can operate machinery with safety.
Latuda treats the symptoms of schizophrenia but does not cure the disease itself. It may take a few weeks for the full benefits of the drug take effect.
DO NOT MIX ALCOHOL WITH THIS DRUG.
Patients should be advised to talk with their doctor about consuming grapefruit or grapefruit juice
while on Latuda.
Patients should not use Latuda if they are also using ketoconazole, antidepressants, antihistamines, carbamazepine, clarithromycin, diltiazem, erythromycin, indinavir, ipratropim, itraconazole, medications for anxiety, any sedatives or sleeping pills, blood pressure medications, glaucoma medications, nefazodone, nelfinavir, phenobarbital, phenytoin, pioglitazone, rifabutin, ritonavir, verapamil, St. John's wort or rifampin.
Other contraindications include bosentan, conivaptan, dexamethasone, imatinib, isoniazid, rifapentine, telithromycin, fluconazole, voriconazole, nicardipine, quinidine, verapamil, atazanavir, delavirdine, efavirenz, etravirine, fosamprenavir, indinavir, nelfinavir, nevirapine, saquinavir, ritonavir, armodafinil, modafinil, felbamate, oxcarbazepine, and primidone.
Latuda has been classified by the FDA in pregnancy category B and is not expected to harm the fetus. However, it may cause problems in newborns if the drug was taken during the last trimester.
It is unknown if Latuda passes into breast milk so nursing mothers should be advised to halt breast feeding or continue breast feeding with caution. Mothers are advised to consult with their physician to weigh the benefits and the risks.