Dysphagia Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality n patients with advanced Alzheimer' s dementia. RISPERDAL ® and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia. Hyperprolactinemia As with other drugs that antagonize dopamine D 2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro , a factor of potential importance if the prescription of these drugs is contemplated in a patient with previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating compounds, the clinical significance of elevated serum prolactin levels is unknown for most patients. As is common with compounds which ncrease prolactin release, an increase in pituitary gland, mammary gland, and pancreatic slet cell hyperplasia and/ or neoplasia was observed in the risperidone carcinogenicity studies conducted in mice and rats ( see PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility) . However, neither clinical studies nor epidemiologic studies conducted to date have shown an association between chronic administration of this class of drugs and tumorigenesis in humans; the available evidence is considered too limited to be conclusive at this time. Potential for Cognitive and Motor Impairment Somnolence was a commonly reported adverse event associated with RISPERDAL ® treatment, especially when ascertained by direct questioning of patients. This adverse event s dose-related, and in a study utilizing a checklist to detect adverse events, 41% of the high-dose patients ( RISPERDAL ® 16 mg/ day) reported somnolence compared to 16% of placebo patients. Direct questioning is more sensitive for detecting adverse events than spontaneous reporting, by which 8% of RISPERDAL ® 16 mg/ day patients and 1% of placebo patients reported somnolence as an adverse event. Since RISPERDAL ® has the potential to mpair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that RISPERDAL ® therapy does not affect them adversely. | ||||
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