EFFEXOR XR

Venlafaxine is an antidepressant in a group of drugs called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). Venlafaxine affects chemicals in the brain that may become unbalanced and cause depression.

Venlafaxine is used to treat major depressive disorder, anxiety, and panic disorder.

INDICATIONS AND USAGE

Major Depressive Disorder

Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder.

The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder.

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial. The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied.

The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial. Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Generalized Anxiety Disorder

Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD) as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

The efficacy of Effexor XR in the treatment of GAD was established in 8-week and 6-month placebo-controlled trials in adult outpatients diagnosed with GAD according to DSM-IV criteria.

Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance.

Although the effectiveness of Effexor XR has been demonstrated in 6-month clinical trials in patients with GAD, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Social Anxiety Disorder

Effexor XR is indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia, as defined in DSM-IV (300.23).

Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.

The efficacy of Effexor XR in the treatment of Social Anxiety Disorder was established in four 12-week and one 6-month placebo-controlled trials in adult outpatients with Social Anxiety Disorder (DSM-IV).

Although the effectiveness of Effexor XR has been demonstrated in a 6-month clinical trial in patients with Social Anxiety Disorder, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Panic Disorder

Effexor XR is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.

Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, ie, a discrete period of intense fear or discomfort, in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: 1) palpitations, pounding heart, or accelerated heart rate; 2) sweating; 3) trembling or shaking; 4) sensations of shortness of breath or smothering; 5) feeling of choking; 6) chest pain or discomfort; 7) nausea or abdominal distress; 8) feeling dizzy, unsteady, lightheaded, or faint; 9) derealization (feelings of unreality) or depersonalization (being detached from oneself); 10) fear of losing control; 11) fear of dying; 12) paresthesias (numbness or tingling sensations); 13) chills or hot flushes.

The efficacy of Effexor XR in the treatment of panic disorder was established in two 12-week placebo-controlled trials in adult outpatients with panic disorder (DSM-IV). The efficacy of Effexor XR in prolonging time to relapse in panic disorder among responders following 12 weeks of open-label acute treatment was demonstrated in a placebo-controlled study. Nevertheless, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Important Safety Information for EFFEXOR XR
Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, teens, and young adults. 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. EFFEXOR XR® (venlafaxine HCl) is not approved for use in children and teens.

• Do not take EFFEXOR XR if you take a Monoamine Oxidase Inhibitor (MAOI) or if you stopped taking an MAOI in the last 2 weeks. Do not take an MAOI within 7 days of stopping EFFEXOR XR. Ask your doctor or pharmacist if you are not sure if your medicine is an MAOI.
• All patients taking antidepressants should be watched closely for signs that their condition is getting worse or that they are becoming suicidal, especially when they first start therapy, or when their dose is increased or decreased. Patients should also be watched for becoming agitated, irritable, hostile, aggressive, impulsive, or restless. Such symptoms should be reported to the patient's doctor right away.
• Before starting EFFEXOR XR, tell your doctor if you're taking or plan to take any prescription or over-the-counter drugs, including migraine headache medication, herbal preparations, and nutritional supplements, to avoid a potentially life-threatening condition.
• EFFEXOR XR may raise blood pressure in some patients. Your blood pressure should be controlled before starting treatment and should be monitored regularly.
• Taking EFFEXOR XR with aspirin, nonsteroidal anti-inflammatory drugs, warfarin, or other drugs that affect coagulation may increase the risk of bleeding events.
• Mydriasis (prolonged dilation of the pupil of the eye) has been reported with EFFEXOR XR. You should notify your physician if you have a history of glaucoma or increased eye pressure.
• When people suddenly stop using or quickly lower their daily dose of EFFEXOR XR, discontinuation symptoms may occur. Talk to your doctor before discontinuing or reducing your dose of EFFEXOR XR.
• Pregnant or nursing women shouldn't take any antidepressant without consulting their doctor.
• Until you see how EFFEXOR XR affects you, be careful doing such activities as driving a car or operating machinery. Avoid drinking alcohol while taking EFFEXOR XR.
• In clinical studies, the most common side effects with EFFEXOR XR (reported in at least 10% of patients and at least twice as often as with placebo) were constipation, dizziness, dry mouth, insomnia, loss of appetite, nausea, nervousness, sexual side effects, sleepiness, sweating, and weakness.

Effexor XR (venlafaxine) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such as:

• seizure (convulsions);
• very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination;
• headache, trouble concentrating, memory problems, weakness, feeling unsteady, confusion, hallucinations, fainting, shallow breathing or breathing that stops;
• cough, chest tightness, trouble breathing; or
• easy bruising.

Less serious side effects may include:

• drowsiness, dizziness, feeling nervous;
• strange dreams;
• increased sweating;
• blurred vision;
• dry mouth;
• changes in appetite or weight;
• mild nausea, constipation; or
• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.