Effexor XR (Page 5 of 15)

Elevations in Systolic and Diastolic Blood Pressure

In placebo-controlled premarketing studies, there were changes in mean blood pressure (see Table 4 for mean changes in supine systolic and supine diastolic blood pressure). Across most indications, a dose-related increase in supine systolic and diastolic blood pressure was evident in Effexor XR-treated patients.

Table 4 Final On-Therapy Mean Changes from Baseline in Supine Systolic and Diastolic Blood Pressure (mm Hg) Results by Indication, Study Duration, and Dose in Placebo-Controlled Trials
1 Supine Systolic Blood Pressure

2 Supine Diastolic Blood Pressure

Effexor XR mg/day Placebo
≤75 >75
SSBP1 SDBP2 SSBP SDBP SSBP SDBP
Major Depressive Disorder
8-12 weeks -0.28 0.37 2.93 3.56 -1.08 -0.10
Generalized Anxiety Disorder
8 weeks -0.28 0.02 2.40 1.68 -1.26 -0.92
6 months 1.27 -0.69 2.06 1.28 -1.29 -0.74
Social Anxiety Disorder
12 weeks -0.29 -1.26 1.18 1.34 -1.96 -1.22
6 months -0.98 -0.49 2.51 1.96 -1.84 -0.65
Panic Disorder
10-12 weeks -1.15 0.97 -0.36 0.16 -1.29 -0.99

Across all clinical trials in MDD, GAD, Social Anxiety Disorder and panic disorder, 1.4% of patients in the Effexor XR-treated groups experienced a ≥15 mm Hg increase in supine diastolic blood pressure with blood pressure ≥105 mm Hg compared to 0.9% of patients in the placebo groups. Similarly, 1% of patients in the Effexor XR-treated groups experienced a ≥20 mm Hg increase in supine systolic blood pressure with blood pressure ≥180 mm Hg compared to 0.3% of patients in the placebo groups.

Mydriasis

Mydriasis has been reported in association with venlafaxine; therefore patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma (angle-closure glaucoma) should be monitored (see PRECAUTIONS, Information for Patients).

PRECAUTIONS

General

Discontinuation of Treatment with Effexor XR

Discontinuation symptoms have been systematically evaluated in patients taking venlafaxine, to include prospective analyses of clinical trials in Generalized Anxiety Disorder and retrospective surveys of trials in major depressive disorder, and Social Anxiety Disorder. Abrupt discontinuation or dose reduction of venlafaxine at various doses has been found to be associated with the appearance of new symptoms, the frequency of which increased with increased dose level and with longer duration of treatment. Reported symptoms include agitation, anorexia, anxiety, confusion, impaired coordination and balance, diarrhea, dizziness, dry mouth, dysphoric mood, fasciculation, fatigue, flu-like symptoms, headaches, hypomania, insomnia, nausea, nervousness, nightmares, sensory disturbances (including shock-like electrical sensations), somnolence, sweating, tremor, vertigo, and vomiting.

During marketing of Effexor XR, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), and SSRIs (Selective Serotonin Reuptake Inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g. paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms.

Patients should be monitored for these symptoms when discontinuing treatment with Effexor XR. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate (see DOSAGE AND ADMINISTRATION).

Insomnia and Nervousness

Treatment-emergent insomnia and nervousness were more commonly reported for patients treated with Effexor XR (venlafaxine hydrochloride) extended-release capsules than with placebo in pooled analyses of short-term major depressive disorder, GAD, Social Anxiety Disorder, and panic disorder studies, as shown in Table 5.

Table 5 Incidence of Insomnia and Nervousness in Placebo-Controlled Major Depressive Disorder, GAD, Social Anxiety Disorder, and Panic Disorder Trials
Major DepressiveDisorder GAD Social AnxietyDisorder Panic Disorder
Symptom Effexor XRn = 357 Placebon = 285 Effexor XRn = 1381 Placebon = 555 Effexor XRn = 819 Placebon = 695 Effexor XRn = 1001 Placebon = 662
Insomnia 17% 11% 15% 10% 24% 8% 17% 9%
Nervousness 10% 5% 6% 4% 10% 5% 4% 6%

Insomnia and nervousness each led to drug discontinuation in 0.9% of the patients treated with Effexor XR in major depressive disorder studies.

In GAD trials, insomnia and nervousness led to drug discontinuation in 3% and 2%, respectively, of the patients treated with Effexor XR up to 8 weeks and 2% and 0.7%, respectively, of the patients treated with Effexor XR up to 6 months.

In Social Anxiety Disorder trials, insomnia and nervousness led to drug discontinuation in 2% and 1%, respectively, of the patients treated with Effexor XR up to 12 weeks and 2% and 3% respectively, of the patients treated with Effexor XR up to 6 months.

In panic disorder trials, insomnia and nervousness led to drug discontinuation in 1% and 0.1%, respectively, of the patients treated with Effexor XR up to 12 weeks.

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