Seroquel - Side Effects & Drug Interactions

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1 Events for which the SEROQUEL incidence was equal to or less than placebo are not listed in the table, but included the following: pain, infection, chest pain, hostility, accidental injury, hypertension, hypotension, nausea, vomiting, diarrhea, myalgia, agitation, insomnia, anxiety, nervousness, akathisia, hypertonia, tremor, depression, paresthesia, pharyngitis, dry skin, amblyopia and urinary tract infection.

Explorations for interactions on the basis of gender, age, and race did not reveal any clinically meaningful differences in the adverse event occurrence on the basis of these demographic factors.

Dose Dependency of Adverse Events in Short-Term, Placebo-Controlled Trials Dose-related Adverse Events:

Spontaneously elicited adverse event data from a study comparing five fixed doses of SEROQUEL (75 mg, 150 mg, 300 mg, 600 mg, and 750 mg/ day) to placebo were explored for dose-relatedness of adverse events. Logistic regression analyses revealed a positive dose response (p< 0.05) for the following adverse events: dyspepsia, abdominal pain, and weight gain.

Extrapyramidal Symptoms

Data from one 6-week clinical trial comparing five fixed doses of SEROQUEL (75, 150, 300, 600, 750 mg/ day) provided evidence for the lack of treatment-emergent extrapyramidal symptoms (EPS) and dose-relatedness for EPS associated with SEROQUEL treatment. Three methods were used to measure EPS:

(1) Simpson-Angus total score (mean change from baseline) which evaluates parkinsonism and akathisia,

(2) incidence of spontaneous complaints of EPS (akathisia, akinesia, cogwheel rigidity, extrapyramidal syndrome, hypertonia, hypokinesia, neck rigidity, and tremor), and

(3) use of anticholinergic medications to treat emergent EPS.

SEROQUEL Dose Groups Placebo 75 mg 150 mg 300 mg 600 mg 750 mg

Parkinsonism 0.6 -1.0 -1.2 -1.6 -1.8 -1.8

EPS incidence 16% 6% 6% 4% 8% 6%

Anticholinergic medications 14% 11% 10% 8% 12% 11%

In three additional placebo-controlled clinical trials using variable doses of SEROQUEL, there were no differences between the SEROQUEL and placebo treatment groups in the incidence of EPS, as assessed by Simpson-Angus total scores, spontaneous complaints of EPS and the use of concomitant anticholinergic medications to treat EPS.