VENLAFAXINE HYDROCHLORIDE (Page 4 of 13)

5.8 Seizures

Seizures have occurred with venlafaxine therapy. Venlafaxine hydrochloride extended-release capsules, like many antidepressants, should be used cautiously in patients with a history of seizures and should be discontinued in any patient who develops seizures. [Must mitigate the risk: Risk factors, concomitant meds that lower the seizure threshold.]

5.9 Hyponatremia

Hyponatremia can occur as a result of treatment with SSRIs and SNRIs, including venlafaxine hydrochloride extended-release capsules. In many cases, the hyponatremia appears to be the result of the Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion. Cases with serum sodium lower than 110 mmol/L have been reported. Elderly patients may be at greater risk of developing hyponatremia with SSRIs and SNRIs [ see Use in Specific Populations (8.5) ]. Also, patients taking diuretics, or those who are otherwise volume-depleted, may be at greater risk. Consider discontinuation of venlafaxine hydrochloride extended-release capsules in patients with symptomatic hyponatremia, and institute appropriate medical intervention.

Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.

5.10 Weight and Height Changes in Pediatric Patients

Weight Changes

The average change in body weight and incidence of weight loss (percentage of patients who lost 3.5% or more) in the placebo-controlled pediatric studies in MDD, GAD, and SAD are shown in Tables 3 and 4.

Table 3: Average Change in Body Weight (kg) From Beginning of Treatment in Pediatric Patients in Double-blind, Placebo-controlled Studies of Venlafaxine Hydrochloride Extended-release Capsules
Indication (Duration) Venlafaxine Hydrochloride Extended-release Capsules Placebo
MDD and GAD (4 pooled studies, 8 weeks) -0.45 (n = 333) +0.77 (n = 333)
SAD (16 weeks) -0.75 (n = 137) +0.76 (n = 148)
Table 4: Incidence (%) of Pediatric Patients Experiencing Weight Loss (3.5% or more) in Double-blind, Placebo-controlled Studies of Venlafaxine Hydrochloride Extended-release Capsules

a p < 0.001 versus placebo

Indication (Duration) Venlafaxine Hydrochloride Extended-release Capsules Placebo
MDD and GAD (4 pooled studies, 8 weeks) 18 a (n = 333) 3.6 (n = 333)
SAD (16 weeks) 47 a (n = 137) 14 (n = 148)

Weight loss was not limited to patients with treatment-emergent anorexia [ see Warnings and Precautions (5.11) ].

The risks associated with longer term venlafaxine hydrochloride extended-release capsules use were assessed in an open-label MDD study of children and adolescents who received venlafaxine hydrochloride extended-release capsules for up to six months. The children and adolescents in the study had increases in weight that were less than expected, based on data from age- and sex-matched peers. The difference between observed weight gain and expected weight gain was larger for children (< 12 years old) than for adolescents (≥ 12 years old).

Height Changes

Table 5 shows the average height increase in pediatric patients in the short-term, placebo-controlled MDD, GAD, and SAD studies. The differences in height increases in GAD and MDD studies were most notable in patients younger than twelve.

Table 5: Average Height Increases (cm) in Pediatric Patients in Placebo-controlled Studies of Venlafaxine Hydrochloride Extended-release Capsules

a p = 0.041

Indication (Duration) Venlafaxine Hydrochloride Extended-release Capsules Placebo
MDD (8 weeks) 0.8 (n = 146) 0.7 (n = 147)
GAD (8 weeks) 0.3 a (n = 122) 1 (n = 132)
SAD (16 weeks) 1 (n = 109) 1 (n = 112)

In the six-month, open-label MDD study, children and adolescents had height increases that were less than expected, based on data from age- and sex-matched peers. The difference between observed and expected growth rates was larger for children (< 12 years old) than for adolescents (≥ 12 years old).

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

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