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Venlafaxine HCl (Effexor® and Effexor XR®) linked to increased BP

« H E » email
posted Thursday, 4 May 2006

Venlafaxine HCl (Effexor® and Effexor XR®) Therapy Linked to Risk for Sustained Hypertension

May 3, 2006 - The US Food and Drug Administration (FDA) has approved safety labeling revisions to advise of the risk for sustained hypertension in patients receiving venlafaxine therapy.

The FDA has approved safety labeling revisions for venlafaxine HCl tablets and extended-release capsules (Effexor and Effexor XR, made by Wyeth Pharmaceuticals, Inc) to warn of the risk for sustained hypertension associated with their use in some patients.

In a premarketing study comparing 3 fixed doses of venlafaxine and placebo, use of a 375-mg/day dose was linked to a mean 7.2-mm Hg increase in supine diastolic blood pressure at 6 weeks compared with no significant changes in patients receiving 75 or 225 mg/day, and a mean decrease in supine diastolic blood pressure of 2.2 mm Hg in those given placebo.

An analysis of data from patients meeting criteria for sustained hypertension (defined as treatment-emergent supine diastolic blood pressure of 90 mm Hg or greater and 10 mm Hg or greater above baseline for 3 consecutive visits) revealed a dose-dependent increase in the incidence of sustained hypertension for venlafaxine (3% at less than 100 mg/day vs 5% at 101 to 200 mg/day vs 7% at 201 to 300 mg/day and 13% at greater than 300 mg/day; placebo, 2%).

An analysis of data from patients with sustained hypertension and those who discontinued the study because of hypertension (<1% of venlafaxine-treated patients) revealed that most of the blood pressure increases were in a modest range (change in supine diastolic blood pressure, 10 to 15 mm Hg).

However, the FDA notes that sustained increases of this magnitude could have adverse consequences; cases of elevated blood pressure requiring immediate treatment have been since reported during postmarketing use of the drug.

The FDA advises that preexisting hypertension be brought under control prior to initiation of venlafaxine therapy and that blood pressure be monitored regularly during treatment. Dose reductions or discontinuation should be considered in patients who experience a sustained increase in blood pressure.

Venlafaxine is indicated for the treatment of major depressive disorder. The recommended starting dose is 75 mg/day, administered in 2 or 3 divided doses, taken with food. The dose may be increased in 75-mg/day increments at 4-day intervals as clinically required and tolerated.

The FDA notes although there is no evidence of usefulness for doses greater than 225 mg/day among patients with moderate depression in outpatient settings, more inpatients with severe depression have responded to a mean dose of 350 mg/day administered in 3 divided doses.


 (Medscape - Free registration required)

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