LUVOX CR®

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)

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]

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.

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). ^[4]

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.