Priapism Rare cases of priapism have been reported. While the relationship of the events to RISPERDAL ® use has not been established, other drugs with alpha-adrenergic blocking effects have been reported to nduce priapism, and it is possible that RISPERDAL ® may share this capacity. Severe priapism may require surgical intervention. Thrombotic Thrombocytopenic Purpura ( TTP) A single case of TTP was reported in a 28 year-old female patient receiving RISPERDAL ® in a large, open premarketing experience ( approximately 1300 patients) . She experienced jaundice, fever, and bruising, but eventually recovered after receiving plasmapheresis. The relationship to RISPERDAL ® therapy is unknown. Antiemetic Effect Risperidone has an antiemetic effect in animals; this effect may also occur n humans, and may mask signs and symptoms of overdosage with certain drugs or of conditions such as intestinal obstruction, Reye' s syndrome, and brain tumor. Body Temperature Regulation Disruption of body temperature regulation has been attributed to antipsychotic agents. Both hyperthermia and hypothermia have been reported in association with oral RISPERDAL ® use. Caution is advised when prescribing for patients who will be exposed to temperature extremes. Suicide The possibility of a suicide attempt s inherent n schizophrenia, and close supervision of high-risk patients should accompany drug therapy. Prescriptions for RISPERDAL ® should be written for the smallest quantity of tablets, consistent with good patient management, in order to reduce the risk of overdose. Use in Patients With Concomitant Illness Clinical experience with RISPERDAL ® in patients with certain concomitant systemic illnesses is limited. Caution is advisable in using RISPERDAL ® in patients with diseases or conditions that could affect metabolism or hemodynamic responses. | ||||
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