Venlafaxine Hydrochloride (Page 5 of 15)

5.11 Appetite Changes in Pediatric Patients

Decreased appetite (reported as treatment-emergent anorexia) was more commonly observed in venlafaxine hydrochloride extended-release capsules treated patients versus placebo-treated patients in the premarketing evaluation of venlafaxine hydrochloride extended-release capsules for MDD, GAD, and SAD (see Table 6).

Table 6: Incidence (%) of Decreased Appetite and Associated Discontinuation Rates a (%) in Pediatric Patients in Placebo-controlled Studies of Venlafaxine Hydrochloride Extended-Release Capsules
a The discontinuation rates for weight loss were 0.7% for patients receiving either venlafaxine hydrochloride extended-release capsules or placebo.
Indication (Duration) Venlafaxine Hydrochloride Extended-Release Capsules Incidence Discontinuation Placebo Incidence Discontinuation
MDD and GAD (pooled, 8 weeks) 10 0 3 -
SAD (16 weeks) 22 0.7 3 0

5.12 Interstitial Lung Disease and Eosinophilic Pneumonia

Interstitial lung disease and eosinophilic pneumonia associated with venlafaxine therapy have been rarely reported. The possibility of these adverse events should be considered in venlafaxine-treated patients who present with progressive dyspnea, cough or chest discomfort. Such patients should undergo a prompt medical evaluation, and discontinuation of venlafaxine therapy should be considered.

6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the label:

6.1 Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Most Common Adverse Reactions

The most commonly observed adverse reactions in the clinical study database in venlafaxine hydrochloride extended-release capsules treated patients in MDD, GAD, SAD, and PD (incidence ≥ 5% and at least twice the rate of placebo) were: nausea (30%), somnolence (15.3%), dry mouth (14.8%), sweating (11.4%), abnormal ejaculation (9.9%), anorexia (9.8%), constipation (9.3%), impotence (5.3%) and decreased libido (5.1%).

Adverse Reactions Reported as Reasons for Discontinuation of Treatment

Combined across short-term, placebo-controlled premarketing studies for all indications, 12% of the 3,558 patients who received venlafaxine hydrochloride extended-release capsules (37.5 to 225 mg) discontinued treatment due to an adverse experience, compared with 4% of the 2,197 placebo-treated patients in those studies.

The most common adverse reactions leading to discontinuation in ≥ 1% of the venlafaxine hydrochloride extended-release capsules treated patients in the short-term studies (up to 12 weeks) across indications are shown in Table 7.

Table 7: Incidence (%) of Patients Reporting Adverse Reactions Leading to Discontinuation in Placebo-controlled Clinical Studies (up to 12 Weeks Duration)
Body System Adverse Reaction Venlafaxine Hydrochloride Extended-Release Capsules n = 3,558 Placebo n = 2,197
Body as a whole
Asthenia 1.7 0.5
Headache 1.5 0.8
Digestive system
Nausea 4.3 0.4
Nervous system
Dizziness 2.2 0.8
Insomnia 2.1 0.6
Somnolence 1.7 0.3
Skin and appendages 1.5 0.6
Sweating 1 0.2

Common Adverse Reactions in Placebo-controlled Studies

The number of patients receiving multiple doses of venlafaxine hydrochloride extended-release capsules during the premarketing assessment for each approved indication is shown in Table 8. The conditions and duration of exposure to venlafaxine in all development programs varied greatly, and included (in overlapping categories) open and double-blind studies, uncontrolled and controlled studies, inpatient (venlafaxine hydrochloride only) and outpatient studies, fixed-dose, and titration studies.

Table 8: Patients Receiving Venlafaxine Hydrochloride Extended-Release Capsules in Premarketing Clinical Studies
a In addition, in the premarketing assessment of venlafaxine hydrochloride, multiple doses were administered to 2,897 patients in studies for MDD.
Indication Venlafaxine Hydrochloride Extended-Release Capsules
MDD 705 a
GAD 1,381
SAD 819
PD 1,314

The incidences of common adverse reactions (those that occurred in ≥ 2% of venlafaxine hydrochloride extended-release capsules treated patients [357 MDD patients, 1,381 GAD patients, 819 SAD patients, and 1,001 PD patients] and more frequently than placebo) in venlafaxine hydrochloride extended-release capsules treated patients in short-term, placebo-controlled, fixed- and flexible-dose clinical studies (doses 37.5 to 225 mg per day) are shown in Table 9.

The adverse reaction profile did not differ substantially between the different patient populations.

Table 9: Common Adverse Reactions: Percentage of Patients Reporting Adverse Reactions (≥ 2% and > placebo) in Placebo-controlled Studies (up to 12 Weeks Duration) across All Indications
a Percentages based on the number of men (venlafaxine hydrochloride extended-release capsules, n = 1,440; placebo, n = 923) b Percentages based on the number of women (venlafaxine hydrochloride extended-release capsules, n = 2,118; placebo, n = 1,274)
Body System Adverse Reaction Venlafaxine Hydrochloride Extended-Release Capsules n = 3,558 Placebo n = 2,197
Body as a whole
Asthenia 12.6 7.8
Cardiovascular system
Hypertension 3.4 2.6
Palpitation 2.2 2
Vasodilatation 3.7 1.9
Digestive system
Anorexia 9.8 2.6
Constipation 9.3 3.4
Diarrhea 7.7 7.2
Dry mouth 14.8 5.3
Nausea 30 11.8
Vomiting 4.3 2.7
Nervous system
Abnormal dreams 2.9 1.4
Dizziness 15.8 9.5
Insomnia 17.8 9.5
Libido decreased 5.1 1.6
Nervousness 7.1 5
Paresthesia 2.4 1.4
Somnolence 15.3 7.5
Tremor 4.7 1.6
Respiratory system
Yawn 3.7 0.2
Skin and appendages
Sweating (including night sweats) 11.4 2.9
Special senses
Abnormal vision 4.2 1.6
Urogenital system
Abnormal ejaculation/orgasm (men) a 9.9 0.5
Anorgasmia (men) a 3.6 0.1
Anorgasmia (women) b 2 0.2
Impotence (men) a 5.3 1

Other Adverse Reactions Observed in Clinical Studies

Body as a whole – Photosensitivity reaction, chills

Cardiovascular system – Postural hypotension, syncope, hypotension, tachycardia

Digestive system – Gastrointestinal hemorrhage [see Warnings and Precautions (5.4)] , bruxism

Hemic/Lymphatic system – Ecchymosis [see Warnings and Precautions (5.4)]

Metabolic/Nutritional – Hypercholesterolemia, weight gain [see Warnings and Precautions (5.10)], weight loss [see Warnings and Precautions (5.10)]

Nervous system – Seizures [see Warnings and Precautions (5.8)] , manic reaction [see Warnings and Precautions (5.6)] , agitation, confusion, akathisia, hallucinations, hypertonia, myoclonus, depersonalization, apathy

Skin and appendages – Urticaria, pruritus, rash, alopecia

Special senses – Mydriasis, abnormality of accommodation, tinnitus, taste perversion

Urogenital system – Urinary retention, urination impaired, urinary incontinence, urinary frequency increased, menstrual disorders associated with increased bleeding or increased irregular bleeding (e.g., menorrhagia, metrorrhagia)

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