Effexor XR

[venlafaxine hydrochloride]

In premarketing major depressive disorder studies, 0.7 (5/ 705) of the Effexor XR-treated patients discontinued treatment because of elevated blood pressure. Among these patients, most of the blood pressure increases were in a modest range (12 to 16 mm Hg, SDBP). In
premarketing GAD studies up to 8 weeks and up to 6 months, 0.7 (10/ 1381) and 1.3 (7/ 535) of the Effexor XR-treated patients, respectively, discontinued treatment because of elevated blood pressure.

Among these patients, most of the blood pressure increases were in a modestrange (12to25mmHg, SDBP up to 8 weeks;8 to 28 mm Hgup to 6 months). In premarketing Social Anxiety Disorder studies up to 12 weeks, 0.4% (1/ 277) of the Effexor XR-treated patients discontinued treatment because of elevated blood pressure. In this patient, the blood pressure increase was modest (13 mm Hg, SDBP).

Sustained increases of SDBP could have adverse consequences. Therefore, it is recommended that patients receiving Effexor XR have regular monitoring of blood pressure. For patients who experience a sustained increase in blood pressure while receiving venlafaxine, either dose reduction or discontinuation should be considered.

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PRECAUTIONS

General

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, and Social Anxiety

Disorder studies, as shown in Table 1.
Table 1
Incidence of Insomnia and Nervousness in Placebo-Controlled Major Depressive Disorder,
GAD, and Social Anxiety Disorder Trials
Major Depressive
Disorder
GAD Social Anxiety
Disorder
Symptom
Effexor XR
n = 357
Placebo
n = 285
Effexor XR
n = 1381
Placebo
n = 555
Effexor XR
n = 277
Placebo
n = 274
Insomnia 17% 11% 15% 10% 23% 7%
Nervousness 10% 5% 6% 4% 11% 3%

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