11:37 AM | February 22, 2012

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 and 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.)

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.

Once-A-Day LUVOX CR has no generic equivalent

  • There is no AB rated substitute
  • Immediate-release fluvoxamine should not be substituted for LUVOX CR
  • Should be dispensed as written (DAW)

Once-A-Day LUVOX CR Dosing

  • Available in 100 mg and 150 mg dose strengths
  • Taken at bedtime with or without food
  • 100 mg/day recommended starting dose
  • Maximum recommended dosage is 300 mg/day

Adverse Events

  • In clinical trials, the most commonly observed adverse reactions with an incidence of ≥5% and at least twice that of placebo were nausea, somnolence, asthenia, diarrhea, anorexia, abnormal ejaculation, tremor, sweating, and anorgasmia.
  • In 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, vomiting, pharyngitis and myalgia.
  • In clinical trials, discontinuation rates due to an adverse reaction were 19% for the OCD population (N=124) and 26% in another studied population (N=279).

Once-A-Day LUVOX CR

  • Proven efficacy in OCD[1][2]
  • Weight-neutral profile (no significant weight gain or loss) vs. placebo in 12 week clinical trials [1][2][3][4]
  • SODAS® (Spheroidal Oral Drug Absorption System) technology
    designed to minimize peak to trough plasma level fluctuations over
    a 24-hour period
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Prescribing Information
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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.

Important Safety Information

CONTRAINDICATIONS

  • The use of thioridazine, tizanidine, pimozide, alosetron or ramelteon with LUVOX CR Capsules is contraindicated.
  • The use of MAO inhibitors in combination with LUVOX CR Capsules, or within 2 weeks of discontinuing treatment with LUVOX CR Capsules is contraindicated. Also, LUVOX CR Capsules should not be administered within 14 days (2 weeks) after discontinuing treatment with an MAOI (See WARNINGS AND PRECAUTIONS).
  • Development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including LUVOX CR treatment, but particularly with concomitant use of serotonergic drugs (including triptans) with drugs that impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine agonists.
  • See WARNINGS AND PRECAUTIONS for other important safety information, including information about drug interactions.

ADVERSE EVENTS

  • In clinical trials, the most commonly observed adverse events with an incidence of ≥5% and at least twice that of placebo were nausea, somnolence, asthenia, diarrhea, anorexia, abnormal ejaculation, tremor, sweating, and anorgasmia.
  • In 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, vomiting, pharyngitis and myalgia.
  • In clinical trials, discontinuation rates due to an adverse reaction were 19% for the OCD population (N=124) and 26% in another studied population (N=279). [2]

DOSING CONSIDERATIONS

  • A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. There have been spontaneous reports of adverse reactions occurring upon discontinuation of SSRIs and SNRIs, particularly when abrupt. Patients should be monitored for these symptoms when discontinuing treatment with LUVOX CR Capsules.
  • SSRIs and SNRIs, including LUVOX CR may increase the risk of bleeding events. Concomitant use of fluvoxamine, NSAIDs, aspirin, warfarin, or other drugs that affect coagulation, should be cautioned.
  • LUVOX CR may impair judgment, thinking, or motor skills; patients should be cautioned until they have adapted to therapy.
  • Screen and monitor for depression, suicidality, and bi-polar disorder.

Please see full prescribing information, including BOXED WARNING, for LUVOX CR.

References:

  1. ^ 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.
  2. ^ LUVOX CR Prescribing Information. Jazz Pharmaceuticals, Inc., Palo Alto, CA.
  3. ^ Davidson, J Yaryura-Tobias J, DuPont R, et al. Fluvoxamine-controlled release formulation for the treatment of generalized social anxiety disorder. J Clin Psychopharmacol. 2004;24:118-125.
  4. ^ Westenberg HGM, Stein DJ, Yang H, et al. A double-blind placebo-controlled study of controlled release fluvoxamine for the treatment of generalized social anxiety disorder. J Clin Psychopharmacol. 2004;24:49-55.

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

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Last update: June 09, 2011