1:02 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.)

What is Obsessive Compulsive Disorder (OCD)?

Obsessive compulsive disorder (OCD) is a common psychiatric disorder, affecting approximately 2.2 million American adults each year.[1][2] OCD causes people to experience unwanted, intrusive thoughts (obsessions) that can prompt them to carry out repeated actions (compulsions) to reduce the anxiety produced by those thoughts.[3] One difference between normal worries and OCD is how much time these behaviors or rituals take out of their day, and how much distress they cause. People with OCD recognize that their thoughts are irrational, but can’t stop them.[3]

Symptoms of OCD

The persistent unwanted obsessions — inappropriate ideas, thoughts, impulses, or images — that people with OCD experience are the kinds of everyday thoughts or worries that could pass through a person’s mind quickly and be dismissed. But those with OCD have trouble doing that, and find these obsessions cannot be controlled.[3]

Some common obsessions include[3]:

  • Aggressive obsessions
  • Contamination obsessions
  • Sexual obsessions
  • Religious obsessions
  • Obsessions with need for symmetry/exactness
  • Miscellaneous obsessions
  • Somatic obsessions

To counteract these obsessions, people with OCD typically use repeated behaviors or thoughts, known as compulsions. Compulsions are often rituals that the person believes may reduce the risk of the obsessions coming true, or at least reduce the anxiety they produce. However, the compulsions often don’t accomplish this, nor are they usually useful in any other way. In fact, the compulsions or rituals can take up so much time from a person’s day that they get in the way of work, school, and family obligations.[3]

Common compulsions include[3]:

  • Checking
  • Washing
  • Counting
  • Ordering
  • Repeating words silently

OCD is Underdiagnosed and Undertreated

OCD can be masked by major depressive disorder, which has a lifetime prevalence of 67% in OCD patients.[4][5] On average, patients delay seeking treatment for 7.5 years.[6] LUVOX CR is approved for OCD.

OCD Affects More Than Just the Patient

OCD impacts not only those directly suffering its effects, but family members, relatives, and caregivers.[7] Often, family members will attempt to accommodate OCD symptoms in afflicted patients, which puts added stress on family relationships, and can interfere with treatment[7][8]

Family members can serve as a valuable resource for patients with OCD, and can help facilitate treatment.[8] Physicians may ask relatives of people with OCD about a family history of OCD or other psychiatric disorders.[8] Information from family members or others can help a physician assess whether a patient is at risk of harming themselves or others.[8] Treatment for people with OCD can involve educating family members about OCD and participation in family therapy in order to support the patient’s recovery.[8]

Treatment Can Help Many People with OCD

Cognitive behavioral therapy (CBT) and medication with selective serotonin reuptake inhibitors (SSRIs) are current first-line treatments for OCD. Every person is different, so some people will find that CBT alone could potentially relieve OCD symptoms and others will find they need a combination of CBT and medication. Some patients may need to augment their initial therapy or change treatments after a sufficient trial period in order to achieve satisfactory results.[8] LUVOX CR has not been studied in combination with CBT.

There are tools available to help identify patients with OCD; a psychiatrist may use these tools to help quantify the severity of OCD, distinguish it from other conditions, and measure response to treatment.[8] These tools include symptom scales such as the Zohar-Fineberg Obsessive-Compulsive Screen[9] and the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS).[8]



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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). [10]

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. ^ National Institute of Mental Health. The Numbers Count: Mental Disorders in America. Available at: http://www.nimh.nih.gov/health/publications/the-numbers-count-mental-disorders- in-america.shtml. Accessed January 10, 2008.
  2. ^ Kessler RC, et al. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication (NCS-R). Archives of General Psychiatry. 2005;62:617-27.
  3. ^ American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th ed, revised. Washington, DC: American Psychiatric Association; 2000.
  4. ^ 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.
  5. ^ Obsessive-Compulsive Disorder. In: Sadock BJ, Sadock VA, eds. Synopsis of Psychiatry. 9th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2003:616-623.
  6. ^ Rasmussen SA, Tsuang MT. Clinical characteristics and family history in DSM-III obsessive-compulsive disorder. Am J Psychiatry. 1986;143:317-322.
  7. ^ Calvocoressi L, et al. Family accommodation in obsessive-compulsive disorder. American Journal of Psychiatry. 1995;152:441-443.
  8. ^ American Psychiatric Association; Koran LM, et al. Practice guideline for the treatment of patients with obsessive-compulsive disorder. American Journal of Psychiatry. 2007;164(suppl):1-56.
  9. ^ National Institute for Health and Clinical Excellence. Obsessive-Compulsive Disorder: Core Interventions in the Treatment of Obsessive-Compulsive Disorder and Body Dysmorphic Disorder. National Clinical Practice Guideline Number 31. London: The British Psychological Society and The Royal College of Psychiatrists; 2006.
  10. ^ 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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