Effexor XR - Warnings & Precautions

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In the pool of GAD studies, treatment-emergent anorexia was reported in 8% and 2 of patients receiving Effexor XR and placebo up to 8 weeks, respectively. A loss of 7 or more of body weight occurred in 3 of the Effexor XR-treated and 1 of the placebo-treated patients up to 6 months in these trials. Discontinuation rates for anorexia and weight loss were low for patients receiving Effexor XR up to 8 weeks (0.9 and 0.3 , respectively).

In the pool of Social Anxiety Disorder studies, treatment-emergent anorexia was reported in 20% and 2% of patients receiving Effexor XR and placebo up to 12 weeks, respectively. A loss of 7% or more of body weight occurred in none of the Effexor XR-treated or the placebo-treated patients up to 12 weeks in these trials. Discontinuation rates for anorexia and weight loss were low for patients receiving Effexor XR up to 12 weeks (0.4% and 0.0%, respectively). The safety and efficacy of venlafaxine therapy in combination with weight loss agents, including phentermine, have not been established. Co-administration of Effexor XR and weight loss agents is not recommended. Effexor XR is not indicated for weight loss alone or in combination with other products.

Activation of Mania/ Hypomania During premarketing major depressive disorder studies, mania or hypomania occurred in 0.3 of Effexor XR-treated patients and 0.0 placebo patients. In premarketing GAD studies, 0.0 of

Effexor XR-treated patients and 0.2 of placebo-treated patients experienced mania or hypomania. In premarketing Social Anxiety Disorder studies, no Effexor XR-treated patients and no placebo-treated patients experienced mania or hypomania.

In all premarketing major depressive disorder trials with Effexor, mania or hypomania occurred in 0.5% of venlafaxine-treated patients compared with 0 of placebo patients. Mania/ hypomania has also been reported in a small proportion of patients with mood disorders who were treated with other marketed drugs to treat major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, Effexor XR should be used cautiously in patients with a history of mania.