Risperdal

[Risperidone]

Dose Dependency of Adverse Events

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Extrapyramidal Symptoms

Data from two fixed-dose trials provided evidence of dose-relatedness for extrapyramidal symptoms associated with risperidone treatment. Two methods were used to measure extrapyramidal symptoms ( EPS) in an 8-week trial comparing 4 fixed doses of risperidone ( 2, 6, 10, and 16 mg/ day) , including ( 1) a parkinsonism score ( mean change from baseline) from the Extrapyramidal Symptom Rating Scale, and ( 2) incidence of spontaneous complaints of EPS:

Other Adverse Events

Adverse event data elicited by a checklist for side effects from a large study comparing 5 fixed doses of RISPERDAL ® ( 1, 4, 8, 12, and 16 mg/ day) were explored for dose-relatedness of adverse events. A Cochran-Armitage Test for trend in these data revealed a positive trend ( p< 0.05) for the following adverse events: sleepiness, increased duration of sleep, accommodation disturbances, orthostatic dizziness, palpitations, weight gain, erectile dysfunction, ejaculatory dysfunction, orgastic dysfunction, asthenia/ lassitude/ increased fatigability, and increased pigmentation.

Vital Sign Changes

RISPERDAL ® is associated with orthostatic hypotension and tachycardia ( see PRECAUTIONS) .

Weight Changes

The proportions of RISPERDAL ® and placebo-treated patients meeting a weight gain criterion of 7% of body weight were compared in a pool of 6-to 8-week, placebo-controlled trials, revealing a statistically significantly greater ncidence of weight gain for RISPERDAL ® ( 18% ) compared to placebo ( 9%).

Laboratory Changes

A between-group comparison for 6-to 8-week placebo-controlled trials revealed no statistically significant RISPERDAL ® / placebo differences in the proportions of patients experiencing potentially important changes in routine serum chemistry, hematology, or urinalysis parameters. Similarly, there were no RISPERDAL ® / placebo differences in the incidence of discontinuations for changes in serum chemistry, hematology, or urinalysis. However, RISPERDAL ® administration was associated with increases in serum prolactin ( see PRECAUTIONS) .

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