5:38 PM | May 25, 2013
EfficacyAdverse EventsSafety Information: CONTRAINDICATIONS and Drug Drug InteractionsDosing and Administration

Warning: 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
LUVOX CR®(fluvoxamine maleate) Extended-Release Capsules or any other antidepressant in a child, adolescent, or young adult must balance the risk with a clinical need. Short-term studies did not show an increase in this risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in 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 close observation and communication with the prescriber. (See WARNINGS AND PRECAUTIONS - Clinical Worsening and Suicide Risk and USE IN SPECIFIC POPULATIONS - Pediatric Use.)

Efficacy

Obsessive Compulsive Disorder (OCD)

OCD is underdiagnosed and undertreated

  • OCD patients are often reluctant to discuss their symptoms and delay seeking treatment an average of 7.5 years[1]
  • OCD can be masked by major depressive disorder, which has a lifetime prevalence of 67% in OCD patients[2][3]
    • LUVOX CR is approved for OCD[4]
  • Some patients with OCD may require higher dosages than are needed in other disease
    states[5]
    • The approved dosage range for LUVOX CR is 100 mg/day to 300 mg/day[4]

OCD has a detrimental impact on many factors of quality of life

  • Level of education[6]
  • Employment status[6][7]
  • Financial independence[6]

LUVOX CR has not been systematically studied for its impact on quality-of-life measures.

With early recognition and treatment, there is a way out…

Once-A-Day LUVOX CR provides statistically significant improvement vs placebo in OCD symptoms as measured by the Y-BOCS at week 12[4][8]

  • Statistical separation from placebo occurred as early as week 2[8]
  • Nausea was the most common adverse reaction, with 6% of patients with OCD and 8% of patients from another studied population discontinuing the trials because of nausea.[4]

Y-BOCS

Results from a multicenter, randomized, double-blind, placebo-controlled study in an intent-to-treat population of 237 adult outpatients with OCD who received LUVOX CR or placebo once-a-day. Mean (SE) baseline Y-BOCS Total Score was 26.6 (0.3) for the LUVOX CR group, which is considered to be severe OCD according to Y-BOCS. An 8.5 point mean change (32% reduction) from baseline resulted in a Y-BOCS Total Score of 18.1 at study end, which is considered to be moderate OCD according to the Y-BOCS.[8][9]

Once-A-Day LUVOX CR (fluvoxamine maleate) Extended-Release Capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in the DSM-IV.

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INDICATION

LUVOX CR® (fluvoxamine maleate) Extended-Release Capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in the DSM-IV. Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.

The efficacy of fluvoxamine for long-term use was established in one maintenance study in adults with immediate-release fluvoxamine tablets (see CLINICAL STUDIES [14.2]). The health care provider who elects to prescribe LUVOX CR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with LUVOX CR is contraindicated.
  • The use of MAOIs intended to treat psychiatric disorders with LUVOX CR or within 14 days of stopping treatment with LUVOX CR is contraindicated because of an increased risk of serotonin syndrome. The use of LUVOX CR within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see Dosing and Administration and Warnings and Precautions).
  • Starting LUVOX CR in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see Dosing and Administration and Warnings and Precautions).

WARNINGS AND PRECAUTIONS

  • Monitor patients for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric disorders. These symptoms may represent precursors to emerging suicidality. Families and caregivers of patients being treated should be alerted about the need for close daily monitoring of patients.
  • Prescriptions for LUVOX CR should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
  • Prior to initiating treatment with an antidepressant, patients should be adequately screened to determine if they are at risk for bipolar disorder. Treatment with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder.
  • The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including LUVOX CR, alone but particularly with concomitant use of serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, 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).

    Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.

    The concomitant use of LUVOX CR with MAOIs intended to treat psychiatric disorders is contraindicated. If concomitant use of LUVOX CR with certain other serotonergic drugs, treatment with LUVOX CR and any concomitant serotonergic agents should be discontinued immediately if the above events occur, and supportive symptomatic treatment should be initiated.

  • Fluvoxamine inhibits several CYP isoenzymes. This may result in drug interactions when Luvox CR is prescribed concomitantly with agents that are metabolized by some isoenzymes (CYP1A2, CYP3A4, CYP2C9, CYP2C19, and CYP2D6).

    A clinically significant fluvoxamine interaction is possible with drugs having a narrow therapeutic ratio such as pimozide, warfarin, theophylline, certain benzodiazepines, omeprazole, and phenytoin. Other potentially important drug interactions may result from coadministration of Luvox CR with the following drugs: benzodiazepines, alprazolam, diazepam, clozapine, methadone, mexiletine, theophylline, warfarin, carbamazepine, litium, tacrine, tricyclic antidepressants, tryptophan and beta-blockers.

    As with other psychotropic medications, patients should be advised to avoid alcohol while taking LUVOX CR.

    Please see Contraindications, Warnings and Precautions, and Drug Interactions in the full Prescribing Information for additional information regarding potential drug-drug interactions for Luvox CR.

  • Symptoms associated with discontinuation have been reported. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible.
  • LUVOX CR, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to this risk.
  • LUVOX CR should be used cautiously in patients with a history of mania.
  • Caution is recommended when the drug is administered to patients with a history of convulsive disorders. Fluvoxamine should be avoided in patients with unstable epilepsy, and patients with controlled epilepsy should be carefully monitored. Treatment with fluvoxamine should be discontinued if seizures occur or if seizure frequency increases.
  • Hyponatremia may occur as a result of treatment with LUVOX CR. Discontinuation of LUVOX CR should be considered in patients with symptomatic hyponatremia.
  • Caution is advised in administering LUVOX CR to patients with diseases or conditions that could affect hemodynamic responses, or metabolism.
  • Patients with hepatic impairment should begin with a low dose of LUVOX CR and increase it slowly with careful monitoring.

ADVERSE REACTIONS

  • In clinical trials, the most commonly observed treatment-emergent adverse reactions associated with the use of LUVOX CR and likely to be drug-related (incidence of 5% or greater and at least twice that for placebo) were: abnormal ejaculation, anorexia, anorgasmia, asthenia, diarrhea, nausea, somnolence, sweating, and tremor. In the one controlled trial in patients with OCD, the following additional reactions occurred at an incidence of 5% or greater and at least twice that for placebo: anxiety, decreased libido, myalgia, pharyngitis, and vomiting. The following additional reactions occurred in another studied population: dyspepsia, dizziness, insomnia, and yawning.
  • In a study evaluating immediate-release fluvoxamine maleate tablets in pediatric patients with OCD, the following additional reactions were identified: agitation, depression, dysmenorrhea, flatulence, hyperkinesia, and rash.

USE IN SPECIAL POPULATIONS

  • Pregnancy: Consider both potential risks and benefits when treating a pregnant woman. Infants exposed to SSRIs in pregnancy have developed various complications and may be at risk for persistent pulmonary hypertension of the newborn (PPHN).
  • Nursing mothers: Fluvoxamine is secreted in human breast milk.
  • Geriatric: Use of a lower starting dose may be warranted. Titrate slowly during initiation of therapy.

Please see full Prescribing Information, including BOXED Warning and Medication Guide, for additional important safety information.

References:

  1. ^ Rasmussen SA, Tsuang MT. Clinical characteristics and family history in DSM-III obsessive-compulsive disorder. Am J Psychiatry. 1986;143:317-322.
  2. ^ Obsessive-Compulsive Disorder. In: Hales RE, Yudofsky SC, Talbott JA, eds. Textbook of Psychiatry. 3rd ed. Washington, DC: American Psychiatric Press, Inc. 1999:600-610.
  3. ^ Obsessive-Compulsive Disorder. In: Sadock BJ, Sadock VA, eds. Synopsis of Psychiatry. 9th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2003:616-623.
  4. ^ LUVOX CR Prescribing Information. Jazz Pharmaceuticals, Inc., Palo Alto, CA.
  5. ^ American Psychiatric Association. Practice guideline for the treatment of patients with obsessive-compulsive disorder. Published July 2007. Accessed September 18, 2007.
  6. ^ Koran LM, Thienemann ML, Davenport R. Quality of life for patients with obsessive-compulsive disorder. Am J Psychiatry. 1996;153:783-788.
  7. ^ American Psychiatric Association. DSM-IV-TR. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Text revision. Washington, DC: American Psychiatric Press, Inc.
  8. ^ Hollander E, Koran LM, Goodman WK, et al. A double-blind, placebo-controlled study of the efficacy and safety of controlled-release fluvoxamine in patients with obsessive-compulsive disorder. J Clin Psychiatry. 2003;64:640-647.
  9. ^ Goodman WK, Price LH, Rasmussen SA, et al. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989;46:1006-1011.

LUVOX CR is a registered trademark of Abbott Products, Inc.
SODAS® is a registered trademark of Elan Pharma International Ltd. (EPIL). US Patent no 7,465,462.

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Last update: January 22, 2013