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Effexor XR

[venlafaxine hydrochloride]

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).

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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.

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