VENLAFAXINE HYDROCHLORIDE (Page 7 of 13)

6.3 Laboratory Changes

Serum Cholesterol

Venlafaxine hydrochloride extended-release capsules was associated with mean final increases in serum cholesterol concentrations compared with mean final decreases for placebo in premarketing MDD, GAD, SAD and PD clinical studies (Table 13).

Table 13: Mean Final On-therapy Changes in Cholesterol Concentrations (mg/dL) in Venlafaxine Hydrochloride Extended-release Capsules Premarketing Studies
Indication Venlafaxine Hydrochloride Placebo
(Duration) Extended-release Capsules
MDD
(12 weeks) +1.5 -7.4
GAD
(8 weeks) +1 -4.9
(6 months) +2.3 -7.7
SAD
(12 weeks) +7.9 -2.9
(6 months) +5.6 -4.2
PD
(12 weeks) 5.8 -3.7

Venlafaxine hydrochloride extended-release capsules (venlafaxine hydrochloride) treatment for up to 12 weeks in premarketing placebo-controlled trials for major depressive disorder was associated with a mean final on-therapy increase in serum cholesterol concentration of approximately 1.5 mg/dL compared with a mean final decrease of 7.4 mg/dL for placebo. Venlafaxine hydrochloride extended-release capsules treatment for up to 8 weeks and up to 6 months in premarketing placebo-controlled GAD trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 1 mg/dL and 2.3 mg/dL, respectively while placebo subjects experienced mean final decreases of 4.9 mg/dL and 7.7 mg/dL, respectively. Venlafaxine hydrochloride extended-release capsules treatment for up to 12 weeks and up to 6 months in premarketing placebo-controlled Social Anxiety Disorder trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 7.9 mg/dL and 5.6 mg/dL, respectively, compared with mean final decreases of 2.9 and 4.2 mg/dL, respectively, for placebo. Venlafaxine hydrochloride extended-release capsules treatment for up to 12 weeks in premarketing placebo-controlled panic disorder trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 5.8 mg/dL compared with a mean final decrease of 3.7 mg/dL for placebo.

Patients treated with venlafaxine tablets (immediate release) for at least 3 months in placebo-controlled 12-month extension trials had a mean final on-therapy increase in total cholesterol of 9.1 mg/dL compared with a decrease of 7.1 mg/dL among placebo-treated patients. This increase was duration dependent over the study period and tended to be greater with higher doses. Clinically relevant increases in serum cholesterol, defined as 1) a final on-therapy increase in serum cholesterol ≥50 mg/dL from baseline and to a value ≥261 mg/dL, or 2) an average on-therapy increase in serum cholesterol ≥50 mg/dL from baseline and to a value ≥261 mg/dL, were recorded in 5.3% of venlafaxine-treated patients and 0% of placebo-treated patients.

Serum Triglycerides

Venlafaxine hydrochloride extended-release capsules was associated with mean final on-therapy increases in fasting serum triglycerides compared with placebo in premarketing clinical studies of SAD and PD up to 12 weeks (pooled data) and 6 months duration (Table 14).

Table 14: Mean Final On-therapy Increases in Triglyceride Concentrations (mg/dL) in Venlafaxine Hydrochloride Extended-release Capsules Premarketing Studies
Indication Venlafaxine Hydrochloride Placebo
(Duration) Extended-release Capsules
SAD 8.2 0.4
(12 weeks)
SAD 11.8 1.8
(6 months)
PD 5.9 0.9
(12 weeks)
PD 9.3 0.3
(6 months)

6.4 Pediatric Patients

In general, the adverse reaction profile of venlafaxine (in placebo-controlled clinical studies) in children and adolescents (ages 6 to 17) was similar to that seen for adults. As with adults, decreased appetite, weight loss, increased blood pressure, and increased serum cholesterol were observed [ see Warnings and Precautions ( 5.3, 5.10, 5.11) and Use in Specific Populations (8.4)].

In pediatric clinical studies, the adverse reaction, suicidal ideation, was observed.

Particularly, the following adverse reactions were observed in pediatric patients: abdominal pain, agitation, dyspepsia, ecchymosis, epistaxis, and myalgia.

6.5 Adverse Reactions Identified During Postapproval Use

The following adverse reactions have been identified during postapproval use of venlafaxine hydrochloride extended-release capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

Body as a whole — Anaphylaxis, angioedema

Cardiovascular system — QT prolongation, ventricular fibrillation, ventricular tachycardia (including torsade de pointes), takotsubo cardiomyopathy

Digestive system — Pancreatitis

Hemic/Lymphatic system — Mucous membrane bleeding [ see Warnings and Precautions (5.4) ], blood dyscrasias (including agranulocytosis, aplastic anemia, neutropenia and pancytopenia), prolonged bleeding time, thrombocytopenia

Metabolic/Nutritional — Hyponatremia [ see Warnings and Precautions (5.9) ], Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion [ see Warnings and Precautions (5.9) ], abnormal liver function tests, hepatitis, prolactin increased

Musculoskeletal — Rhabdomyolysis

Nervous system — Neuroleptic Malignant Syndrome (NMS) [ see Warnings and Precautions (5.2) ], serotonergic syndrome [ see Warnings and Precautions (5.2) ], delirium, extrapyramidal reactions (including dystonia and dyskinesia), impaired coordination and balance, tardive dyskinesia

Respiratory system Respiratory system — Dyspnea, interstitial lung disease, pulmonary eosinophilia [ see Warnings and Precautions (5.12) ]

Skin and appendages — Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme

Special senses — Angle-closure glaucoma [ see Warnings and Precautions (5.5) ]

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