Effexor XR - Warnings & Precautions

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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.

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%

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 3% and 0%, respectively, of the patients treated with Effexor XR up to 12 weeks.

Changes in Appetite and Weight

Treatment-emergent anorexia was more commonly reported for Effexor XR-treated (8 ) than placebo-treated patients (4 ) in the pool of short-term studies in major depressive disorder.

Significant weight loss, especially in underweight depressed patients, may be an undesirable result of Effexor XR treatment. A loss of 5 or more of body weight occurred in 7 of Effexor XR-treated and 2 of placebo-treated patients in placebo-controlled major depressive disorder trials. Discontinuation rates for anorexia and weight loss associated with Effexor XR were low (1.0 and 0.1 , respectively, of Effexor XR-treated patients in major depressive disorder studies).