Effexor XR - Warnings & Precautions

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Experience with the immediate-release venlafaxine showed that sustained hypertension was dose-related, increasing from 3% to 7 at 100 to 300 mg/ day to 13 at doses above 300 mg/ day. An insufficient number of patients received mean doses of Effexor XR over 300 mg/ day to fully evaluate the incidence of sustained increases in blood pressure at these higher doses. In placebo-controlled premarketing studies in patients with major depressive disorder with Effexor XR 75 to 225 mg/ day, a final on-drug mean increase in supine diastolic blood pressure (SDBP) of 1.2 mm Hg was observed for Effexor XR-treated patients compared with a mean decrease of 0.2 mm Hg for placebo-treated patients. In placebo-controlled premarketing GAD studies with Effexor XR 37.5 to 225 mg/ day, up to 8 weeks or up to 6 months, a final on-drug mean increase in SDBP of 0.3 mm Hg was observed for Effexor XR-treated patients compared with a mean decrease of 0.9 and 0.8 mm Hg, respectively, for placebo-treated patients. In placebo-controlled premarketing Social Anxiety Disorder studies with Effexor XR 75 to 225 mg/ day up to 12 weeks, a final on-drug mean increase in SDBP of 1.6 mm Hg was observed for Effexor XR-treated patients compared with a mean decrease of 1.1 mm Hg for placebo-treated patients.

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).