Effexor XR (Page 10 of 15)

ADVERSE REACTIONS

The information included in the Adverse Findings Observed in Short-Term, Placebo-Controlled Studies with Effexor XR subsection is based on data from a pool of three 8- and 12-week controlled clinical trials in major depressive disorder (includes two U.S. trials and one European trial), on data up to 8 weeks from a pool of five controlled clinical trials in GAD with Effexor XR® , on data up to 12 weeks from a pool of five controlled clinical trials in Social Anxiety Disorder, and on data up to 12 weeks from a pool of four controlled clinical trials in panic disorder. Information on additional adverse events associated with Effexor XR in the entire development program for the formulation and with Effexor (immediate release) is included in the Other Adverse Events Observed During the Premarketing Evaluation of Effexor and Effexor XR subsection (see also WARNINGS and PRECAUTIONS).

Adverse Findings Observed in Short-Term, Placebo-Controlled Studies with Effexor XR

Adverse Events Associated with Discontinuation of Treatment

Approximately 11% of the 357 patients who received Effexor XR® (venlafaxine hydrochloride) extended-release capsules in placebo-controlled clinical trials for major depressive disorder discontinued treatment due to an adverse experience, compared with 6% of the 285 placebo-treated patients in those studies. Approximately 18% of the 1381 patients who received Effexor XR capsules in placebo-controlled clinical trials for GAD discontinued treatment due to an adverse experience, compared with 12% of the 555 placebo-treated patients in those studies. Approximately 15% of the 819 patients who received Effexor XR capsules in placebo-controlled clinical trials for Social Anxiety Disorder discontinued treatment due to an adverse experience, compared with 5% of the 695 placebo-treated patients in those studies. Approximately 7% of the 1,001 patients who received Effexor XR capsules in placebo-controlled clinical trials for panic disorder discontinued treatment due to an adverse experience, compared with 6% of the 662 placebo-treated patients in those studies. The most common events leading to discontinuation and considered to be drug-related (ie, leading to discontinuation in at least 1% of the Effexor XR-treated patients at a rate at least twice that of placebo for any indication) are shown in Table 6.

Table 6 Common Adverse Events Leading to Discontinuation of Treatment in Placebo-Controlled Trials1
1 Two of the major depressive disorder studies were flexible dose and one was fixed dose. Four of the GAD studies were fixed dose and one was flexible dose. Four of the Social Anxiety Disorder studies were flexible dose and one was fixed/flexible dose. Two of the panic disorder studies were flexible dose and two were fixed dose.

2 In U.S. placebo-controlled trials for major depressive disorder, the following were also common events leading to discontinuation and were considered to be drug-related for Effexor XR-treated patients (% Effexor XR [n = 192], % Placebo [n = 202]): hypertension (1%, <1%); diarrhea (1%, 0%); paresthesia (1%, 0%); tremor (1%, 0%); abnormal vision, mostly blurred vision (1%, 0%); and abnormal, mostly delayed, ejaculation (1%, 0%).

3 In two short-term U.S. placebo-controlled trials for GAD, the following were also common events leading to discontinuation and were considered to be drug-related for Effexor XR-treated patients (% Effexor XR [n = 476]), % Placebo [n = 201]: headache (4%, <1%); vasodilatation (1%, 0%); anorexia (2%, <1%); dizziness (4%, 1%); thinking abnormal (1%, 0%); and abnormal vision (1%, 0%).

4 In long-term placebo-controlled trials for GAD, the following was also a common event leading to discontinuation and was considered to be drug-related for Effexor XR-treated patients (% Effexor XR [n = 535], % Placebo [n = 257]): decreased libido (1%, 0%).

5 In a 6-month placebo-controlled trial for Social Anxiety Disorder, the following was also a common event leading to discontinuation and was considered to be drug-related for Effexor XR-treated patients (% Effexor XR [n = 257], % Placebo [n = 129]: depression (5%, 0%), libido decrease (1%, 0%), and nervousness (3%, 0%).

6 Incidence is based on the number of men (Effexor XR = 454, placebo = 357).

Percentage of Patients Discontinuing Due to Adverse Event
Adverse Event Major Depressive Disorder Indication 2 GAD Indication 3,4 Social Anxiety Disorder Indication 5 Panic Disorder Indication
Effexor XR n = 357 Placebo n = 285 Effexor XR n = 1381 Placebo n = 555 Effexor XR n = 819 Placebo n = 695 Effexor XR n = 1001 Placebo n = 662
Body as a Whole
Asthenia 3% <1% 2% <1% 1% 0%
Headache 1% <1%
Digestive System
Nausea 4% <1% 8% <1% 3% <1% 2% <1%
Anorexia 1% <1%
Dry Mouth 1% 0% 2% <1%
Vomiting 1% <1%
Nervous System
Dizziness 2% 1% 2% <1%
Insomnia 1% <1% 3% <1% 2% <1% 1% 1%
Somnolence 2% <1% 3% <1% 2% <1%
Nervousness 2% <1%
Tremor 1% 0%
Skin
Sweating 2% <1%
Urogenital System
Impotence6 2% 0%

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