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Prozac
Generic Name: Fluoxetine Hydrochloride
Drug Category: SSRI
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 7 years old for a maximum duration of 1 year.
| Approved Uses |
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Indicated for: Major Depressive Disorder (MDD): (adult and pediatric patients 8 years of age and older) • Acute and maintenance treatment of Major Depressive Disorder (MDD). Obsessive Compulsive Disorder (OCD): (adult and pediatric patients 7 years of age and older) • Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). Bulimia Nervosa: (adults): • Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. Panic Disorder: (adults): • Acute treatment of Panic Disorder, with or without agoraphobia. PROZAC and olanzapine in combination is indicated for: Depressive Episodes Associated with Bipolar I Disorder (adult and pediatric patients 10 years of age and older): • Acute treatment of Depressive Episodes Associated with Bipolar I Disorder. Treatment Resistant Depression (adults): • Treatment Resistant Depression (Major Depressive Disorder in patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). PROZAC and olanzapine in combination have not been systematically studied in patients over 65 years of age or in patients less than 10 years of age. PROZAC monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. A major depressive episode may be the initial presentation of Bipolar Disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for Bipolar Disorder. Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for Bipolar Disorder; such screening should include a detailed psychiatric history, including a family history of suicide, Bipolar Disorder, and depression. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Significant weight loss, especially in underweight depressed or bulimic patients, may be an undesirable result of treatment with PROZAC. Patients should be advised that taking Prozac can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Hyponatremia has been reported during treatment with SNRIs and SSRIs, including PROZAC. Post-marketing cases of QT interval prolongation and ventricular arrhythmia including Torsades de Pointes have been reported in patients treated with PROZAC. PROZAC should be used with caution in patients with congenital long QT syndrome; a previous history of QT prolongation; a family history of long QT syndrome or sudden cardiac death; and other conditions that predispose to QT prolongation and ventricular arrhythmia. Since the introduction of PROZAC, systemic reactions, possibly related to vasculitis and including lupus-like syndrome, have developed in patients with rash. Although these reactions are rare, they may be serious, involving the lung, kidney, or liver. Death has been reported to occur in association with these systemic reactions. Anaphylactoid reactions, including bronchospasm, angioedema, laryngospasm, and urticaria alone and in combination, have been reported. Pulmonary reactions, including inflammatory processes of varying histopathology and/or fibrosis, have been reported rarely. These reactions have occurred with dyspnea as the only preceding symptom. Hypoglycemia has occurred during therapy with PROZAC, and hyperglycemia has developed following discontinuation of the drug. As is true with many other types of medication when taken concurrently by patients with diabetes, insulin and/or oral hypoglycemic, dosage may need to be adjusted when therapy with PROZAC is instituted or discontinued. PROZAC should be introduced with care in patients with a history of seizures. As with any CNS-active drug, PROZAC has 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 the drug treatment does not affect them adversely. Use of SSRIs, including PROZAC, may cause symptoms of sexual dysfunction. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm. PROZAC is contraindicated:
Serotonin syndrome has been reported with SSRIs and SNRIs, including PROZAC, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). SNRIs and SSRIs, including fluoxetine, may increase the risk of bleeding reactions. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to this risk. There are no clinical studies establishing the benefit of the combined use of ECT and fluoxetine. There have been rare reports of prolonged seizures in patients on fluoxetine receiving ECT treatment. Because fluoxetine is tightly bound to plasma proteins, adverse effects may result from displacement of protein-bound fluoxetine by other tightly-bound drugs. Stable plasma levels of imipramine and desipramine have increased greater than 2- to 10-fold when fluoxetine has been administered in combination. Co-administration of fluoxetine with other drugs that are metabolized by CYP2D6, including certain antidepressants (e.g., TCAs), antipsychotics (e.g., phenothiazines and most atypicals), and antiarrhythmics (e.g., propafenone, flecainide, and others) should be approached with caution. Co-administration of alprazolam and fluoxetine has resulted in increased alprazolam plasma concentrations and in further psychomotor performance decrement due to increased alprazolam levels. Elevation of blood levels of haloperidol and clozapine has been observed in patients receiving concomitant fluoxetine. Patients on stable doses of phenytoin and carbamazepine have developed elevated plasma anticonvulsant concentrations and clinical anticonvulsant toxicity following initiation of concomitant fluoxetine treatment. There have been reports of both increased and decreased lithium levels when lithium was used concomitantly with fluoxetine. Cases of lithium toxicity and increased serotonergic effects have been reported. When treating pregnant women with PROZAC during the third trimester, the physician should carefully consider the potential risks and potential benefits of treatment. Neonates exposed to SNRIs or SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Infants exposed to SSRIs in pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). One prospective cohort study conducted by the European Network of Teratology Information Services reported an increased risk of cardiovascular malformations in infants born to women exposed to fluoxetine during the first trimester of pregnancy compared to infants of women who were not exposed to fluoxetine. Because PROZAC is excreted in human milk, nursing while taking PROZAC is not recommended. |
| Off-label Uses |
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• Acute and maintenance treatment of major depressive disorder in patients under the age of 8. GoToSource • Acute and maintenance treatment of obsessive compulsive disorder in patients under the age of 7. GoToSource • Acute and maintenance treatment of bulimia nervosa in patients under the age of 18. GoToSource • Acute treatment of panic disorder, with or without agoraphobia, in patients under the age of 18. GoToSource • Use with olanzapine for acute treatment of depressive episodes associated with bipolar I disorder in patients under the age of 10. GoToSource • Monotherapy for depressive episodes associated with bipolar I disorder or the treatment of treatment resistant depression. GoToSource • Premature ejaculation, migraine headaches, diabetic neuropathy pain, fibromyalgia and neurocardiogenic syncope. GoToSource • Borderline personality disorder. GoToSource • Adjunctive therapy for symptoms of schizophrenia. GoToSource • Depersonalization disorder. GoToSource • Adjunctive therapy for motor deficits in post-stroke patients. GoToSource • Autism spectrum disorders. GoToSource • Post-traumatic stress disorder. GoToSource • Nonparaphilic sexual addictions and paraphilias. GoToSource • Social phobia. GoToSource • Irritable bowel syndrome. GoToSource • Familial mediterranean fever. GoToSource • Slow-channel congenital myasthenic syndrome. GoToSource • Adjunctive therapy to prevent heroin addiction relapse. GoToSource • Treatment for zolpidem abuse and dependence. GoToSource • Idiopathic recurrent priapism. GoToSource • Premenstrual syndrome. GoToSource • Use with buspirone for breathing problems in rett syndrome. GoToSource • Use with ondansetron for obstructive sleep apnea syndrome. GoToSource • Tinnitus. GoToSource |
| Adverse Events |
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⚠️ Prolonged effects of fluoxetine and higher concentrations of fluoxetine in patients with CYP2D6 gene variation. Serotonin syndrome or neuroleptic malignant syndrome like reactions. GoToSource Fetal toxicity including ventricular septal defects, persistent pulmonary hypertension and increased risk for autism spectrum disorders. GoToSource Reports of violent behavior, Prozac is 10.9 times more likely to be linked with violence in comparison with other medications. GoToSource Withdrawal symptoms including anxiety, agitation, aggression, headache, sensory disturbance and fatigue. GoToSource Increased risk of suicidal thoughts or behavior (suicidality). GoToSource Drug-induced long QT and arrhythmia. GoToSource Gastrointestinal tract bleeding. GoToSource Apathy syndrome (primary lack of motivation). GoToSource Use with antiplatelet therapy increases risk of bleeding following acute myocardial infarction. GoToSource Drug-induced brugada syndrome (cardiac arrhythmia). GoToSource Hemostatic abnormalities including decreased platelet aggregability and activity and prolongation of bleeding time. GoToSource Non-traumatic spontaneous spinal subdural hematoma. GoToSource Akathisia (movement disorder). GoToSource Glaucoma. GoToSource Seizures. GoToSource Hyponatremia (low blood sodium). GoToSource Sexual dysfunction. GoToSource |
| Litigation |
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Lawsuits filed for suicides, violent behavior, akathisia, birth defects and withdrawal symptoms. |
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