1:03 AM | February 07, 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.)

Obsessive Compulsive Disorder (OCD) Resources and Links

Below is a listing of some useful links and resources.

These websites and organizations are listed for the benefit of those that may be interested in them. Jazz Pharmaceuticals, Inc. is not connected to or responsible for the content of the websites listed with the exception of OCDCenter.org which is a Jazz Pharmaceuticals Inc. sponsored site.

Anxiety Disorders Association of America (ADAA)

ADAA is a national, non-profit organization. Their objective is to inform the public, healthcare professionals, and legislators about the real and serious problems that anxiety disorders present. They see these disorders as treatable and advocate early diagnosis and treatment as the first steps to a cure.

International Obsessive Compulsive Disorder Foundation (IOCDF)

IOCDF is an international, not-for-profit organization made up of people with OCD and related disorders. This site focuses on the lives of these individuals and how the disorder affects family, social, and work environments. They encourage family, friends, and coworkers of those dealing with OCD to become involved.

National Alliance on Mental Illness (NAMI)

NAMI is an organization made up of people who suffer from serious mental illnesses. Their goal is to improve the day-to-day lives of these people and their families.

National Institute of Mental Health (NIMH)

NIMH is an organization that believes research on mind, brain, and behavior holds the key to understanding and reducing the problems associated with mental illness and behavioral disorders.

National Mental Health Information Center Services Locator

The National Mental Health Information Center Services Locator is a site that provides extensive information about where to find mental health resources and services throughout the United States.

OCDCenter.org

Informational resource center about OCD, its symptoms, and treatment information.

WebMD on Obsessive Compulsive Disorder (OCD)

WebMD provides valuable health information, tools for managing your health, and support to those who seek information.

Patients Website
Click here to access LUVOX CR information for patients.
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Prescribing Information
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Questions about LUVOX CR
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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). [1]

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. ^ LUVOX CR Prescribing Information. Jazz Pharmaceuticals, Inc., Palo Alto, CA.

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: January 14, 2011