Doctor En Medicina

DEPRESION RESISTENTE – Combinación FXT/OLANZAPINA

Important Safety Information about Olanzapine and Olanzapine + Fluoxetine HCl Combination

Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10weeks), largely in patients taking atypical antipsychotics, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, mostof the deaths appeared to be either cardiovascular (eg, heart failure or sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychoticdrug as opposed to some characteristic(s) of the patient is not clear. Olanzapine is not approved for the treatment of patients with dementia-related psychosis.

Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder(MDD) and other psychiatric disorders. Anyone considering the use of fluoxetine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placeboin adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for closeobservation and communication with the prescriber. Olanzapine + fluoxetine combination is not approved for use in children and adolescents.
Contraindications
* Fluoxetine should not be used with an MAOI or within at least 14 days of discontinuing an MAOI. At least 5 weeks should be allowed after stopping fluoxetine before starting an MAOI.
* Thioridazine should not be given with fluoxetineor within at least 5 weeks after stopping fluoxetine.
* Concomitant use of fluoxetine in patients taking pimozide is contraindicated.

Warnings and Precautions
* Clinical Worsening and Suicide Risk--All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes inbehavior, especially within the first few months of treatment and when changing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication in patients whose depression is persistently worse or includes symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania,mania, or suicidality that are severe, abrupt in onset, or were not part of the patient's presenting symptoms. If discontinuing treatment, the medication should be tapered. Families and caregivers or patients being treated with antidepressants for any indication should be alerted about the need to monitor patients. Prescriptions for olanzapine + fluoxetine combination should be written for the...