General: Body Temperature Regulation: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic drugs. Appropriate care is advised when prescribing pms-RISPERIDONE for patients who will be experiencing conditions which may contribute to an elevation or reduction of core temperature, e.g., exercising strenuously, exposure to extreme heat or cold, receiving concomitant medication with anticholinergic activity, or being subject to dehydration (see Post-Market Adverse Drug Reactions under Adverse Reactions).
QT Interval: As with other antipsychotics, caution should be exercised when pms-RISPERIDONE is prescribed in patients with a history of cardiac arrhythmias, in patients with congenital long QT syndrome, and in concomitant use with drugs known to prolong the QT interval.
Falls: Somnolence, postural hypotension, motor and sensory instability have been reported with the use of antipsychotics, including pms-RISPERIDONE, which may lead to falls and, consequently, fractures or other fall-related injuries. For patients, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects assess the risk of falls when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.
Carcinogenesis and Mutagenesis: Carcinogenesis: Carcinogenicity studies were conducted in Swiss albino mice and Wistar rats. Risperidone was administered in the diet at doses of 0.63, 2.5 and 10 mg/kg for 18 months to mice and for 25 months to rats. These doses are equivalent to 2.4, 9.4 and 37.5 times the maximum recommended human dose (MRHD) (16 mg/day) on a mg/kg basis or 0.2, 0.75 and 3 times the MRHD (mice) or 0.4, 1.5 and 6 times the MRHD (rats) on a mg/m2 basis. A maximum tolerated dose was not achieved in male mice. There were statistically significant increases in pituitary gland adenomas, endocrine pancreas adenomas, and mammary gland adenocarcinomas. Table 6 summarizes the multiples of the human dose on a mg/m2 (mg/kg) basis at which these tumours occurred. (See Table 6.)
Click on icon to see table/diagram/image
Antipsychotic drugs have been shown to chronically elevate prolactin levels in rodents. Serum prolactin levels were not measured during the risperidone carcinogenicity studies; however, measurements during subchronic toxicity studies showed that risperidone elevated serum prolactin levels 5- to 6-fold in mice and rats at the same doses used in the carcinogenicity studies. An increase in mammary, pituitary, and endocrine neoplasms has been found in rodents after chronic administration of other antipsychotic drugs and is considered to be prolactin-mediated. The relevance for human risk of the findings of prolactin-mediated endocrine tumours is unknown (see Endocrine and Metabolism: Hyperprolactinemia as follows).
Mutagenicity: Risperidone had no mutagenic effects when tested by the DNA-repair test in rat hepatocytes, the Ames reverse mutation test in Salmonella typhimurium and Escherichia coli, the mammalian cell gene mutation test in mouse lymphoma cells, the sex-linked recessive lethal test in Drosophila melanogaster, the chromosome aberration test in human lymphocytes and Chinese hamster lung cells, and the micronucleus test in the mouse bone marrow cells.
Impairment of Fertility: Risperidone (0.16 to 5 mg/kg) was shown to impair mating, but not fertility, in Wistar rats in three reproductive studies (two Segment I and a multigenerational study) at doses 0.1 to 3 times the maximum recommended human dose (MRHD) on a mg/m2 basis. The effect appeared to be in females, since impaired mating behaviour was not noted in the Segment I study in which males only were treated. In a subchronic study in Beagle dogs in which risperidone was administered at doses of 0.31 to 5 mg/kg, sperm motility and concentration were decreased at doses 0.6 to 10 times the MRHD on a mg/m2 basis. Dose-related decreases were also noted in serum testosterone at the same doses. Serum testosterone and sperm parameters partially recovered, but remained decreased after treatment was discontinued. No no-effect doses were noted in either rat or dog.
Cardiovascular: During clinical trials, risperidone has been observed to cause orthostatic hypotension and tachycardia, especially during the initial dose titration period and the first few weeks of treatment. Rare cases of syncope, cardiac arrhythmias and first-degree AV-block have been reported. Clinically significant hypotension has also been observed post-marketing with concomitant use of risperidone and antihypertensive treatment. The likelihood of excessive hypotension or syncope can be minimized by limiting the initial dose of the drug to 1-2 mg per day, o.d. or b.i.d., in adult patients and to 0.25 to 0.5 mg b.i.d. in special patient populations, and by increasing the dose slowly (see Recommended Dose and Dosage Adjustment: Adults; and Recommended Dose and Dosage Adjustment: Special Populations: Patients Prone to Hypotension under Dosage & Administration). A dose reduction should be considered if hypotension occurs.
Patients with a history of clinically significant cardiac disorders were excluded from clinical trials. Therefore, pms-RISPERIDONE should be used with caution in patients with cardiovascular diseases (e.g., heart failure, history of myocardial infarction or ischemia, cerebrovascular disease, conduction abnormalities) and other conditions such as dehydration and hypovolemia. Special care should be taken to avoid hypotension in patients with a history of cerebrovascular insufficiency or ischemic heart disease, and in patients taking medications to lower blood pressure. Monitoring of orthostatic vital signs should be considered in all such patients.
Endocrine and Metabolism: Hyperglycemia and Diabetes Mellitus: As with some other antipsychotics, hyperglycemia, diabetes mellitus and exacerbation of pre-existing diabetes, in some cases serious and associated with ketoacidosis or hyperosmolar coma or death, have been reported during the use of risperidone (see Post-Market Adverse Drug Reactions under Adverse Reactions). Diabetic ketoacidosis (DKA) has occurred in patients treated with antipsychotics with no reported history of hyperglycemia. Appropriate clinical monitoring of patients treated with antipsychotics is advisable in accordance with utilized antipsychotic guidelines.
Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available.
Any patient treated with atypical antipsychotics, including pms-RISPERIDONE, should be monitored for symptoms of hyperglycemia and diabetes mellitus including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia and diabetes mellitus during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of the suspect drug. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control.
Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
Hyperprolactinemia: As with other atypical antipsychotics that antagonize dopamine D2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration.
Schizophrenia: In controlled clinical trials, prolactin levels were higher in patients treated with risperidone than in haloperidol-treated patients; however, the incidence of solicited adverse events considered to be possibly prolactin related in patients treated with risperidone (≤ 10 mg/day) was low (< 6%), and similar to that in haloperidol-treated patients (see Clinical Trial Adverse Drug Reactions: Schizophrenia and Related Psychotic Disorders: Hyperprolactinemia - Table 7 under Adverse Reactions).
Bipolar disorder: In controlled clinical trials, patients treated with risperidone had higher prolactin levels than patients treated with haloperidol. The incidence of potentially prolactin related adverse events in patients treated with 1 - 6 mg/day risperidone was 2.3%, and greater than what was reported for patients on placebo (0.5%) or haloperidol (0%) (see Clinical Trial Adverse Drug Reactions: Bipolar Disorder - Mania: Incidence of Adverse Events and Hyperprolactinemia under Adverse Reactions).
Since tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, pms-RISPERIDONE should only be administered to patients with previously detected breast cancer if the benefits outweigh the potential risks. Caution should also be exercised when considering pms-RISPERIDONE treatment in patients with pituitary tumours. Possible manifestations associated with elevated prolactin levels are amenorrhea, galactorrhea, gynecomastia, abnormal sexual function, ejaculation failure, decreased libido, impotence, nonpuerperal lactation and menorrhagia (see Clinical Trial Adverse Drug Reactions: Bipolar Disorder - Mania: Incidence of Adverse Events and Hyperprolactinemia under Adverse Reactions). Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone mineral density in both female and male subjects.
In carcinogenicity studies, the administration of risperidone resulted in an increase in the incidence of mammary neoplasms in both rats and mice. In addition, adenomas of the endocrine pancreas in male rats and pituitary adenomas in female mice have been noted (see Pharmacology: Toxicology: Carcinogenicity under Actions). These changes have been attributed to elevated prolactin levels and have also been observed with other dopamine receptor antagonists. The physiological differences between rats and humans with regard to prolactin make the clinical significance of these findings unclear. To date, neither clinical studies nor epidemiological studies have shown an association between chronic administration of these drugs and mammary tumorigenesis.
Weight Gain: Significant weight gain has been reported in both clinical trials and post-marketing. Monitoring weight gain is advised when pms-RISPERIDONE is being used (see Post-Market Adverse Drug Reactions under Adverse Reactions).
Schizophrenia: In pooled 6- to 8-week placebo-controlled clinical trials, which compared risperidone and placebo in the treatment of schizophrenia, 18% of patients treated with risperidone and 9% of placebo-treated patients met a weight gain criterion of ≥ 7% of baseline body weight. This difference was statistically significant. With continued treatment, weight gain (mean: 2.3 kg in long-term studies) has been seen.
Bipolar disorder: In the 3-week controlled clinical trials, the incidence of weight increases of ≥ 7% was similar among patients treated with placebo, risperidone and haloperidol (2.5%, 2.6% and 3.5%, respectively). The incidence of patients with weight increases of ≥ 7% was higher with longer treatment duration: 16.7% in patients who received an additional 9 weeks of risperidone during open-label treatment extensions and 15% and 11% in patients treated for a total of 12 weeks with risperidone and haloperidol, respectively.
Gastrointestinal: Antiemetic Effect: Consistent with its dopamine antagonistic effects, risperidone may have an antiemetic effect. Such an effect may mask signs of toxicity due to overdosage with other drugs, or may mask symptoms of disease such as brain tumour, or intestinal obstruction or Reye's syndrome.
Genitourinary: Priapism: Drugs with alpha-adrenergic blocking effects have been reported to induce priapism. Priapism has been reported with risperidone during post-marketing surveillance. This adverse reaction, as with other psychotropic drugs, did not appear to be dose dependent and did not correlate with the duration of treatment.
Hematologic: Leukopenia, Neutropenia, and Agranulocytosis Class Effect: In clinical trial and/or post-marketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including risperidone. Granulocytopenia and agranulocytosis have also been reported.
Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug-induced leukopenia/neutropenia. Patients with a history of a clinically significant low WBC or a drug-induced leukopenia/neutropenia should be monitored during the first few months of therapy and discontinuation of pms-RISPERIDONE should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count < 1 x 109/L) should discontinue pms-RISPERIDONE and have their WBC followed until recovery (see Post-Market Adverse Drug Reactions under Adverse Reactions).
Venous Thromboembolism: Venous thromboembolism (VTE), including fatal pulmonary embolism, has been reported with antipsychotic drugs, including risperidone, in case reports and/or observational studies.
When prescribing pms-RISPERIDONE all potential risk factors for VTE should be identified and preventative measures undertaken.
Hepatic/Biliary/Pancreatic: Although the pharmacokinetics of risperidone in patients with hepatic impairment were comparable to those in young volunteers, the free fraction of risperidone was increased by about 35% (see Pharmacology: Pharmacokinetics: Special Populations and Conditions - Table 3 under Actions). Since this may lead to a more pronounced pharmacological effect, lower starting doses and lower maximal doses are recommended in patients with any degree of hepatic impairment (see Recommended Dose and Dosage Adjustment: Special Populations: Patients with Impaired Liver Function under Dosage & Administration).
Immune: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Post market cases of DRESS have been reported with the use of risperidone.
Neurologic: Neuroleptic Malignant Syndrome (NMS): Neuroleptic malignant syndrome is a potentially fatal symptom complex that has been reported in association with antipsychotic drugs, including risperidone.
Clinical manifestations of NMS are hyperthermia, muscle rigidity, altered mental status (including catatonic signs) and evidence of autonomic instability (irregular blood pressure, tachycardia, cardiac arrhythmias, and diaphoresis). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure.
In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system pathology.
The management of NMS should include: 1) immediate discontinuation of all antipsychotic drugs including risperidone, and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.
If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrence of NMS has been reported.
Tardive Dyskinesia (TD): A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with conventional antipsychotic drugs. Although TD appears to be most prevalent in the elderly, especially elderly females, it is impossible to predict at the onset of treatment which patients are likely to develop TD. It has been suggested that the occurrence of parkinsonian side effects is a predictor for the development of TD. In clinical studies, the observed incidence of drug-induced parkinsonism was lower with risperidone than with haloperidol. In the optimal clinical dose range, the difference between risperidone and haloperidol was significant. The risk of developing TD may be less with risperidone. In longer-term clinical studies, risperidone was associated with a lower incidence of treatment-emergent dyskinesia compared to haloperidol.
The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although less commonly, after relatively brief periods of treatment at low doses. There is no known treatment for established cases of TD. The syndrome may remit, partially or completely, if antipsychotic drug treatment is withdrawn. However, antipsychotic drug treatment itself may suppress the signs and symptoms of TD, thereby masking the underlying process. The effect of symptom suppression upon the long-term course of TD is unknown.
In view of these considerations, pms-RISPERIDONE should be prescribed in a manner that is most likely to minimize the risk of TD. As with any antipsychotic drug, pms-RISPERIDONE should be reserved for patients who appear to be obtaining substantial benefit from the drug. In such patients, the smallest dose and the shortest duration of treatment should be sought. The need for continued treatment should be reassessed periodically.
If signs and symptoms of TD develop during treatment with risperidone, withdrawal of the drug should be considered. However, some patients may require treatment with pms-RISPERIDONE despite the presence of the syndrome.
Extrapyramidal symptoms and psychostimulants: Caution is warranted in patients receiving both psychostimulants (e.g., methylphenidate) and risperidone concomitantly, as extrapyramidal symptoms could emerge when adjusting one or both medications. Gradual withdrawal of one or both treatments should be considered (see Drug-Drug Interactions: Effects of Risperidone on the Metabolism of Other Drugs: Psychostimulants under Interactions).
Potential Effect on Cognitive and Motor Performance: Since risperidone may cause somnolence, patients should be cautioned against driving a car or operating hazardous machinery until they are reasonably certain that pms-RISPERIDONE does not affect them adversely.
Schizophrenia: In controlled clinical trials (see Clinical Trial Adverse Drug Reactions: Schizophrenia and Related Psychotic Disorders: Adverse Events in North American Studies - Table 8 and Adverse Events in All International Trials - Table 9 under Adverse Reactions), the incidence of somnolence in patients on risperidone was clinically similar to placebo (3 - 4% of patients on risperidone ≤ 10 mg versus 1% of patients on placebo).
Bipolar disorder: In controlled clinical trials for the acute management of manic episodes (see Clinical Trial Adverse Drug Reactions: Bipolar Disorder - Mania: Incidence of Adverse Events - Table 12 under Adverse Reactions), the incidence of somnolence was higher in patients treated with risperidone compared to placebo or haloperidol (12% of patients on risperidone 1 - 6 mg/day versus 4% of patients on placebo and 4% of patients on haloperidol).
Seizures: Antipsychotic drugs are known to lower the seizure threshold. In clinical trials, seizures have occurred in a few patients treated with risperidone. Therefore, caution should be used in administering pms-RISPERIDONE to patients having a history of seizures or other predisposing factors.
Use in Patients with Parkinson's Disease or Dementia with Lewy Bodies (DLB): Physicians should weigh the risks versus the benefits when prescribing antipsychotics, including pms-RISPERIDONE, to patients with Parkinson's Disease or Dementia with Lewy Bodies (DLB) since both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotic medications. Manifestation of this increased sensitivity can include confusion, obtundation, and postural instability with frequent falls, in addition to extrapyramidal symptoms.
Ophthalmologic: Intraoperative Floppy Iris Syndrome: Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in patients treated with medicines with alpha1a-adrenergic antagonist effect, including risperidone (see Post-Market Adverse Drug Reactions under Adverse Reactions).
This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs and potential prolapse of the iris toward the phacoemulsification incisions. IFIS may increase the risk of eye complications during and after the operation. Current or past use of medicines with alpha1a-adrenergic antagonist effect should be made known to the ophthalmic surgeon in advance of surgery. The potential benefit of stopping alpha1 blocking therapy prior to cataract surgery has not been established and must be weighed against the risk of stopping the antipsychotic therapy.
Psychiatric: Suicide: The possibility of suicide or attempted suicide is inherent in psychosis and bipolar mania, and thus, close supervision and appropriate clinical management of high-risk patients should accompany drug therapy.
Renal: The pharmacokinetics of risperidone were significantly altered in patients with renal disease. In patients with moderate to severe renal disease, clearance of risperidone and its active metabolite 9-hydroxyrisperidone, combined, decreased by 60%, compared to young, healthy subjects (see Pharmacology: Pharmacokinetics: Special Populations and Conditions - Table 3 under Actions). Therefore, lower starting doses and lower maximal doses of pms-RISPERIDONE are recommended in patients with any degree of renal impairment. It may also be useful to monitor renal function in these patients (see Recommended Dose and Dosage Adjustment: Special Populations: Patients with Impaired Kidney Function under Dosage & Administration).
Use in Children: The safety and efficacy of risperidone in children under the age of 18 have not been established and its use is not recommended.
Weight gain has been observed with atypical antipsychotic use in pediatric and adolescent patient populations. Independent of any drug-specific effects, weight gain can be associated with adverse changes in other metabolic parameters (e.g., glucose and lipid metabolism). Abnormal childhood weight and metabolic status can have adverse effects on cardiovascular outcomes in adulthood.
Weight gain and adverse effects on other metabolic parameters associated with typical antipsychotics can be more frequent or more severe in pediatric and adolescent patients than in the adult patients.
The long-term safety, including cardiometabolic effects and effects on growth, maturation and behavioural development in patients under 18 years of age has not been systematically evaluated.
Use in Elderly: Geriatric patients generally have decreased renal, hepatic and cardiac function, and an increased tendency to postural hypotension. Therefore, lower starting doses, lower rates of dose adjustment and lower maximal doses are recommended in these patients.
Risperidone is substantially excreted by the kidneys. Thus, the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, caution should be taken in dose selection and titration. It may also be useful to monitor renal function in these patients (see Pharmacology: Pharmacokinetics: Special Populations and Conditions - Table 3 under Actions; Recommended Dose and Dosage Adjustment: Special Populations: Geriatrics under Dosage & Administration).
In schizophrenic patients, doses exceeding 3 mg per day are not recommended. In patients with severe dementia of the Alzheimer type undergoing treatment for aggression or psychotic symptoms, the optimal dose is 0.5 mg b.i.d. (1.0 mg per day) and the maximal dose is 1 mg b.i.d. (2.0 mg per day).
Use in Geriatric Patients with Dementia: Overall Mortality: Elderly patients with dementia treated with atypical antipsychotic drugs have an increased mortality compared to placebo in a meta-analysis of 13 controlled trials of various atypical antipsychotic drugs. In six placebo-controlled trials with risperidone in this population, the incidence of mortality was 4.0% for risperidone-treated patients compared to 3.1% for placebo-treated patients.
Concomitant Use with Furosemide: In risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%; mean age 89 years, range 75-97) when compared to patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96), furosemide alone (4.1%; mean age 80 years, range 67-90) or placebo without furosemide (2.9%; mean age 88 years, range 71-100). The increase in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials.
No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed. Nevertheless, caution should be exercised, and the risks and benefits of this combination should be considered, prior to the decision to use. There was no increased incidence of mortality among patients taking other diuretics as concomitant medication with risperidone. Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be carefully avoided in elderly patients with dementia.
Cerebrovascular Adverse Events (CVAEs) in Elderly Patients with Dementia: Analysis of clinical trials in elderly patients with dementia suggests that the use of risperidone in dementia patients may be associated with an increased incidence of reports of CVAEs such as stroke and transient ischemic attacks, including fatalities. In placebo-controlled trials, there was a significantly higher incidence of CVAEs in patients treated with risperidone compared to placebo-treated patients (see Clinical Trial Adverse Drug Reactions: Cerebrovascular Adverse Events (CVAEs) in Elderly Patients with Dementia under Adverse Reactions). There is insufficient information to determine whether CVAEs in elderly patients with dementia are associated specifically with risperidone or other antipsychotic agents.
Therefore, physicians are advised to assess risks and benefits of the use of pms-RISPERIDONE in elderly patients with dementia taking into account risk predictors for stroke in the individual patient. Patients/caregivers should be advised to immediately report signs and symptoms of potential CVAEs such as sudden weakness or numbness in the face, arms or legs, and speech or vision problems (see Adults: Severe Dementia of the Alzheimer type - Symptomatic management of aggression and psychotic symptoms under Indications/Uses; Recommended Dose and Dosage Adjustment: Adults: Severe Dementia of the Alzheimer Type under Dosage & Administration; Clinical Trial Adverse Drug Reactions: Cerebrovascular Adverse Events (CVAEs) in Elderly Patients with Dementia under Adverse Reactions).
All treatment options should be considered without delay, including discontinuation. Furthermore, caution should be exercised in prescribing pms-RISPERIDONE to patients with vascular comorbidities, such as hypertension and cardiovascular disease (see Cardiovascular as previously mentioned).
Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer's dementia. pms-RISPERIDONE and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia.