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RISPERDAL® (risperidone)

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Adverse Event of RISPERDAL - Vision Disorders

Last Updated: 01/02/2024

Summary

  • The percentage of adult patients with schizophrenia reporting blurred vision during 3 double-blind risperidone trials was 3% for patients receiving 2-8 mg/day of risperidone (n=366), 1% for patients receiving >8-16 mg/day of risperidone (n=198) and 1% for placebo patients (n=225).1
  • Results from 4 double-blind trials in adult patients with bipolar mania revealed blurred vision in 2% of patients receiving risperidone 1-6 mg/day (n=448) and in 1% of patients receiving placebo (n=424).1
  • In a double-blind trial of pediatric patients with bipolar mania, blurred vision was reported in 4% of patients receiving 0.5-2.5 mg/day of risperidone (n=50), 7% of patients receiving 3-6 mg/day of risperidone (n=61), and 0% of placebo patients (n=58).1
  • Blurred vision was reported in adolescent,2-5 adult,6-18 19-21 and geriatric22 patients.
  • Miosis was observed in risperidone overdoses.23-25 In a case series of overdoses,26 mydriasis was observed in 1 patient and miosis in another.
  • Abnormal visual accommodation has been reported.27-32
  • Conjunctivitis has been reported during dementia trials.33-36
  • Color discrimination,37 xanthopsia,38 cystoid macular edema39,40 dry eyes,41,42 lipemia retinalis,43 palpebral ptosis,44 papilledema,45 and paroxysmal perceptual alteration46 have been reported.
  • In the CATIE trial, new cases of cataract were reported in 2/260 risperidone patients.47 In phase 1B of the trial, a new case of cataract was observed in 1 risperidone patient.48
  • Ocular hyperemia, eye discharge, conjunctivitis, eye rolling, eyelid edema, eye swelling, eyelid margin crusting, dry eye, increased lacrimation, photophobia, glaucoma, reduced visual acuity and eye infection were reported in <1% of adult patients or <5% of pediatric patients across placebo-controlled, active-controlled, and open-label studies of risperidone.1
  • Blepharospasm (Meige syndrome) has been reported in 2 adults49,50 and 1 adolescent male.44
  • A significant positive dose-related trend has been noted for the occurrence of vision abnormalities (Cochran-Armitage test; P<0.05).1

Clinical Data

Accommodation Disorders


Accommodation Disturbances Reported During Risperidone Use
Study Design
Summary
Double-Blind Pivotal Trials - Adult Schizophrenia
Peuskens et al (1995)30 conducted an 8-week, multinational, parallel-group, double-blind study assessing the safety and efficacy of risperidone vs haloperidol in 1362 patients with Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revision chronic schizophrenia.
Fixed Risperidone Doses:
1 mg/day (mean age: 38.4 years)
4 mg/day (mean age: 38.1 years)
8 mg/day (mean age: 37.6 years)
12 mg/day (mean age: 37.9 years)
16 mg/day (mean age: 38.5 years)
Fixed Haloperidol Dose :10 mg/day (mean age: 38.2 years)
Concomitant Medications: as needed hypnotic/daytime sedatives (lorazepam, oxazepam, or temazepam) and/or extrapyramidal symptom medication (biperiden or procyclidine)
Outcomes: As per the Utvalg for Kliniske Undersogelser Side-effect Rating Scale, the following percentages of patients experienced an increase in the symptom severity of accommodation disturbances by at least 1 score compared to baseline.
Percentage of patients with accommodation disturbances:
Risperidone 1 mg (n=226): 8.9%
Risperidone 4 mg (n=227): 8.8%
Risperidone 8 mg (n=228): 14%
Risperidone 12 mg (n=225): 13.3%
Risperidone 16 mg (n=224): 17%
Haloperidol 10 mg (n=225): 17.3%
Marder et al (1994)29 conducted an 8-week, multicenter, prospective, randomized, double-blind, fixed dose trial assessing the safety, efficacy, and optimal dose of risperidone compared to placebo and haloperidol in 388 Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revision schizophrenic patients.
Fixed Risperidone Doses:
2 mg/day (mean age: 39.3 years)
6 mg/day (mean age: 37.5 years)
10 mg/day (mean age: 36.2 years)
16 mg/day (mean age: 36.5 years)
Fixed Haloperidol Dose:
20 mg/day (mean age: 38 years)
Placebo: 37.1 years
Concomitant Medications: as needed sedative/hypnotic (lorazepam or chloral hydrate) and/or extrapyramidal symptom medication
Outcomes: The Utvalg for Kliniske Undersogelser scale item, accommodation disturbances (P<0.05), elicited from the patients, was positively and significantly related to the dose of risperidone (Cochran-Armitage test, 2-tailed, using z score approximations).

Blurred Vision


Blurred Vision Reported During Risperidone Use
Study Design
Summary
Double-Blind Pivotal Trials - Adolescent Bipolar Disorder
The safety and efficacy of risperidone in the treatment of acute manic or mixed episodes in children and adolescents (aged 10-17 years) with Bipolar I Disorder was evaluated in a 3-week, randomized, double-blind, placebo-controlled trial by Haas et al (2009).4
169 patients were randomized to receive placebo (n=58), risperidone 0.5-2.5 mg/day (n=50), or risperidone 3-6 mg/day (n=61).
  • Concomitant medications permitted during the trial were for treatment of extrapyramidal symptoms and/or control of agitation, irritability, restlessness, insomnia and hostility (sedative/hypnotic during washout and week 1, double-blind phase only).
  • Treatment emergent blurred vision was observed in <10% of risperidone-treated patients.
Open-Label Studies
Fleischhaker et al (2006)3 conducted an open-label study evaluating a supplemental version of the Dosage Record Treatment Emergent Symptom Scale for measuring the presence and severity of atypical neuroleptic side effects in 51 adolescent German patients (mean age: 16.1 years).
Patients were treated with clozapine (n=16; mean dose: 321.9 mg/day), olanzapine (n=16; mean dose: 16.6 mg/day), or risperidone (n=19; mean dose: 3.9 mg/day) for a mean duration of 7.4 weeks.
  • Side effects were prospectively monitored on a weekly basis for the first 3 weeks in initially hospitalized patients and every 4 weeks or upon discharge in the case of stable medication.
  • The study sample consisted of 25 drug-naïve patients and 26 patients previously treated with classical or atypical antipsychotics.
  • Blurred vision was observed in 2 patients from each treatment group.
  • Concomitant medication received by 14 patients included: amisulpride, chlorprotixene, fluoxetine, fluvoxamine, haloperidol, imipramine, lactulose, levomepromazine, lorazepam, metixene, metoclopramide, metoprolol, paroxetine, perazine, pimozide, pipamperone, pirenzepine, promethazine, and/or anticholinergic medications (biperiden).
Case Reports
Uzun et al (2004)51 reported the case of a 36 year-old male with psychosis schizoaffective who experienced blurred vision following adjunctive treatment with risperidone.
The patient was receiving promazine 400 mg daily, alprazolam 0.75 mg daily, zolpidem 10 mg daily, and fluoxetine 20 mg daily when risperidone 2 mg daily was initiated. Due to persisting positive symptoms, risperidone was increased to 12 mg daily and promazine was discontinued. The patient fully remitted after 4 weeks of therapy but experienced blurred vision after 6 weeks.
  • No organic cause of blurred vision was revealed.
  • Hematology, biochemistry and urinalysis values were within normal range. Brain magnetic resonance imaging was normal and neuropsychological assessment excluded cranial trauma or slow progressive process induced lesions and diffuse brain damage.
  • No pigment mottling or macular region disturbances were observed on ophthalmoscopy.
  • Two weeks following a risperidone dosage reduction to 4 mg/day, the patient reported vision recovery without worsening of mental condition.

Cataract


Cataract Reported During Risperidone Use
Study Design
Summary
Open-Label Studies
Laties et al (2015)52 conducted a 2-year, randomized, open-label, ophthalmologist-masked, flexible-dose, parallel-group study to determine the cataract rate in 1098 patients with schizophrenia or schizoaffective disorder receiving quetiapine or risperidone.
Exclusions: narrow-angle glaucoma or eye disease; previous intraocular surgery; baseline lens rating of >0 for posterior subcapsular opacification, >1 for cortical opacification, or >2 for nuclear opalescence; continuous systemic steroids for >3 months or an illness likely to require steroid treatment; unstable or inadequately treated diabetes; use of concomitant agents known to cause cataracts (eg, psoralens, allopurinol)
Quetiapine Group: n=596; mean age: 40.2 years (343 Males:253 Females)
Prior medication of risperidone: 32.6%
Prior medication of quetiapine: 26.3%
Mean dose: 386.3 mg/day (range, 25-821 mg/day)
Mean duration of exposure: 345.1 days
Risperidone Group: n=502; mean age: 40.6 years (303 Males:199 Females)
Mean dose: 3.2 mg/day (range, 1.2-8 mg/day)
Mean duration of exposure: 399.3 days
Prior medication of risperidone: 32.9%
Prior medication of quetiapine: 25.1%
A total of 161 quetiapine patients and 168 risperidone patients were included in the 2-year per protocol eye evaluation analysis set.
  • Cortical subcapsular opacification:
    • Quetiapine: 2 events (4.76%)
    • Risperidone: 8 events (1.24%)
    • Risk difference: -0.035 (95% confidence interval: -0.072 to 0.001; P=0.063)
  • Nuclear opalescence:
    • Quetiapine: 0 events
    • Risperidone: 2 events (1.19%)
    • Risk difference: -0.012 (95% confidence interval: -0.028 to 0.004; P=0.165)
  • Posterior subcapsular opacification:
    • Quetiapine: 4 events (2.48%)
    • Risperidone: 7 events (4.17%)
    • Risk difference: -0.017 (95% confidence interval: -0.055 to 0.022; P=0.396)
  • Any event (post hoc):
    • Quetiapine: 6 (3.73%)
    • Risperidone: 16 (9.52%)
    • Risk difference: -0.058 (95% confidence interval: -0.111 to -0.005; P=0.035)

Adverse events leading to discontinuation of treatment (occurring in ≥2 patients):
  • Cortical cataract: n=6 risperidone
  • Nuclear cataract: n=2 risperidone
  • Subcapsular cataract: n=2 quetiapine, n=3 risperidone
Souza et al (2008)53 conducted an open-label study to determine the cataract rate in 80 Brazilian schizophrenic patients receiving long-term antipsychotic therapy.
Exclusions: diabetes; systemic arterial hypertension; previously diagnosed ocular diseases; ocular trauma; past/present use of steroids or amiodarone
Group 1 (typical antipsychotic use ≥2 years): n=52; mean age: 37.2 years (36 Males:16 Females)
Mean chlorpromazine equivalent dose: 667.4 mg/day (P<0.05 vs Group 2)
Mean duration of therapy: 189.8 months (P<0.01 vs Group 2)
Group 2 (atypical antipsychotic use ≥2 years): n=28; mean age: 31.5 years (15 Males:13 Females)
Mean chlorpromazine equivalent dose: 426.6 mg/day
Mean duration of therapy: 52.3 months
Concomitant Medications (Group 1: Group 2):
antidepressants (n=6: n=7); anticholinergics (n=23: n=5; P=0.034); benzodiazepines (n=21: n=3; P=0.012)
Cataract (anterior capsular cataract predominance) was observed in 26 patients (33%).
  • Group 1, which used typical antipsychotics (70% phenothiazine) at higher dosages for longer durations when compared to group 2, had higher cataract rates (40% vs 18%, respectively).
  • Of the 5 patients from group 2 who presented with lenticular opacities, 3 had used olanzapine, 1 risperidone, and 1 risperidone, olanzapine, and ziprasidone.
  • The additive effect of concomitant drug use on lens opacity cannot be neglected.

Cystoid Macular Edema


Cystoid Macular Edema Reported During Risperidone Use
Study Design
Summary
Case Report
Kozlova et al (2019)40 reported a case of cystoid macular edema (CME) in a 69-year-old female with history of hypertension, schizophrenia, depression and primary open-angle glaucoma who was reportedly compliant with all current medications, including latanoprost. The patient had been treated with risperidone 2 mg/day for 1 year with a dose increase to 3 mg/day in the last 2 years.
  • The patient developed ocular symptoms 1 year after the dose was increased.
  • Visual acuity: right eye 20/150 left eye 20/200
  • Examination showed bilateral CME
  • Fluorescein angiography confirmed bilateral petaloid leakage
  • Risperidone was reduced to 2 mg/day with no changes noted to her other medications.
  • The CME resolved by the 4-month follow-up visit; visual acuity improved to 20/40 in both eyes; additionally, no edema was noted at a later follow-up 18 months after presentation.
Manousaridis et al (2013) 39 reported a case of CME in a 65-year-old female with depression and chronic obstructive pulmonary disease.
The patient was receiving risperidone 1 mg twice daily, along with salbutamol and tiotropium (dosages not specified).
  • The patient presented with a 5-week history of bilateral visual blurring.
  • The patient started risperidone treatment 4 months earlier. The patient’s initial compliance was intermittent but was regular over the previous 2 months.
  • Best corrected visual acuity was 6/18 right eye and 6/12 left eye.
  • The patient was diagnosed with bilateral CME.
  • Risperidone was discontinued. The patient noted rapid visual improvement.
  • Two weeks after discontinuation of risperidone, acuity was 6/6 right eye and 6/9 left eye.
  • CME resolved bilaterally on funduscopy and on optical coherence tomography.

Color Discrimination


Color Discrimination Reported During Risperidone Use
Study Design
Summary
Open-Label Study
Vile et al (1997)37 conducted an open-label study assessing the effects of antipsychotic medication on visual function in schizophrenic patients.
  • Color discrimination was assessed using the Farnsworth-Munsell test, and sensitivity to motion in the peripheral field of vision.
  • Patients were receiving long-acting typical antipsychotics in a dose range equivalent to 300-500 mg/week of chlorpromazine (n=6), oral risperidone (2-8 mg/day, n=4), or clozapine (50-300 mg/day, n=5). Healthy controls were matched according to age (n=10).
  • The authors concluded that patients with schizophrenia, regardless of treatment, displayed impaired color discrimination.  The motion sensitivity test revealed that only clozapine-treated patients had difficulties in motion detection.

Dry Eyes


Dry Eyes Reported During Risperidone Use
Study Design
Summary
Retrospective Chart Review
Gowtami et al (2023)41 conducted a cross-sectional observational study (August 2021 to January 2023) to assess the prevalence of dry eye disease in 150 patients with schizophrenia or other psychotic disorders receiving antipsychotic medications for more than 2 years.
  • Sixty patients were on a single drug therapy, including haloperidol, chlorpromazine, and risperidone.
  • Ninety patients were on multiple drug therapy, including haloperidol and chlorpromazine (n=52), risperidone and chlorpromazine (n=30), and haloperidol, chlorpromazine, and risperidone (n=8).
  • Dry eye disease was reported in 32% (n=48) of patients on antipsychotic therapy for >2 years.
    • Twenty patients (33.3%; 20/60) were on a single drug therapy.
    • Thirty-five patients (42.6%; 35/82) were on dual drug therapy.
    • Five patients (62.5%; 5/8) were on multiple drug therapy.
  • Of the 3 antipsychotics used in the study, dry eye disease occurred more frequently with chlorpromazine vs haloperidol or risperidone.
  • Of the patients on the dual drug therapy, dry eye disease was reported more with haloperidol and chlorpromazine vs risperidone and chlorpromazine.
  • Overall, the disease was more prevalent with typical antipsychotics (chlorpromazine and haloperidol) vs risperidone.
Martin et al (2003)42 conducted an observation study (September 23, 1999 to October 15, 2000) to assess adverse effects in 730 elderly dementia patients (mean age: 81 years) receiving risperidone or olanzapine for at least 90 days.
  • Mean doses of risperidone and olanzapine at day 91 were 1 mg/day and 4.7 mg/day, respectively.
  • Anticholinergic effects were assessed 7 days before and during the last 7 days of treatment.
  • The addition of, or increase in the use of, lubricating eye drops was evaluated to determine the frequency of dry eyes.
  • The percent of patients using lubricating eye drops increased 2.1% in the risperidone group and 0.6% in the olanzapine group (P=0.372).
  • The average number of daily doses of eye lubricant received per patient increased from 0.59 to 0.64 (7.9%) in the risperidone group and from 0.58 to 0.75 (29.7%) in the olanzapine group (P=0.417).

Lipemia Retinalis


Lipemia Retinalis Reported During Risperidone Use
Study Design
Summary
Case Report
Gopal et al (2004)43 reported a case of lipemic aqueous and lipemia retinalis in a 32-year-old poorly controlled male diabetic.
The patient presented with a 3-day history of reduced vision and whitening of the right eye. He has a history of diabetes, controlled with diet for the past 3 years, and schizophrenia, treated for the past several months with risperidone 4 mg/day following 5 years of treatment with chlorpromazine.
Ophthalmology Examination: Visual acuity for the right and left eye were 20/60 and 20/20, respectively.
  • Slit-lamp examination revealed circumcorneal congestion of the right eye. Cornea was clear. Anterior chamber was of normal depth and had a dense, turbid, milky aqueous but no cells were found. The iris was hazy while the pupil was sluggishly reactive to light. Coaxial illumination revealed a healthy red fundal glow. Fundus was difficult to visualize. Ultrasonography of the right eye was normal.
  • Except for whitening of the limbal vessels, the anterior segment of the left eye was normal. In the fundus, all of the blood vessels had a milky appearance, typical of lipemia rentinalis. The rest of the fundus and optic disk were normal.

Diagnoses/Treatment: Hyperlipidemia, diabetic ketoacidosis, and lipemia retinalis were diagnosed. The patient was treated with insulin, intravenous fluids, topical ocular steroid drops (6x daily), and started on a fat-free diet.
  • His vision returned to 20/20 within 5 days. Aqueous in the right eye cleared and lipemia retinalis disappeared (normal fundus).
  • Six months following the episode the patient was receiving insulin and oral antidiabetic agents to control his diabetes in addition to risperidone for his schizophrenia.

Meige Syndrome (Blepharospasm)


Meige Syndrome Reported During Risperidone Use
Study Design
Summary
Case Study
Yoshimura et al (2016)50 reported a case of Meige syndrome (blepharospasm and oromandibular symptoms) following treatment of risperidone 4 mg/day for schizophrenia in a 44-year-old Japanese male.
  • One year following initiation of risperidone, the patient started to experience symptoms of Meige syndrome. The patient’s magnetic resonance imaging was not particular with no infarctions or lacunar infarctions.
  • His therapy was changed from risperidone 4 mg/day to paliperidone 3 mg/day and titrated to 6 mg/day and then maintained on 12 mg/day.
  • Two months following treatment change, his symptoms started to improve and completely remitted at 6 months.
Miyamoto et al (2007)49 reported a case of Meige syndrome (blepharospasm and tongue tremor) following treatment of schizophrenia with low-dose risperidone and fluvoxamine in a 33-year-old male.
  • Upon admission, laboratory results and brain computed tomography were normal. Patient's family history was negative for movement disorders.
  • Initial treatment with risperidone monotherapy 4 mg/day for 2 months resulted in psychotic symptom reduction but the patient suffered from decreased libido and ejaculatory deficit. Risperidone was decreased to 2 mg/day. After 5 months, predominant negative symptoms were observed resulting in the addition of fluvoxamine 50 mg/day to his current treatment.
  • Severe blepharospasm and tongue tremor appeared 2 days following the coadministration of risperidone and fluvoxamine. Fluvoxamine was discontinued and risperidone was decreased to 1 mg/day. Satisfactory results were not obtained 1 week following the change in therapy, therefore risperidone was switched to olanzapine 10 mg/day.
  • Ten days later, blepharospasm significantly resolved but somnolence, reported 2 months later, resulted in a dosage decrease to 5 mg/day. Two weeks following dosage decrease, blepharospasm and tongue tremor completely resolved. No other side effects were observed while there was a marked improvement of negative symptoms and control of psychotic symptoms.

Palpebral Ptosis


Palpebral Ptosis Reported During Risperidone Use
Study Design
Summary
Observational Cohort Study
Harrison-Woolrych et al (2007)44 conducted a nationwide, prospective, cohort study assessing the postmarketing safety and usage of atypical antipsychotics between April and July of 2003 in 420 New Zealand children (mean age: 10 years).
  • Total exposure to atypicals was 7694 patient-months, with the majority of patients exposed to risperidone (94%; 7252 patient-months).
  • Palpebral ptosis was reported in a 5-year-old girl receiving risperidone 4 mg/day. The ptosis was considered related to risperidone treatment and resolved following dosage reduction.

Papilledema


Papilledema Reported During Risperidone Use
Study Design
Summary
Open Label Trials - Disruptive Behavior Disorders
Haas et al (2008)45 conducted a 1-year, open-label extension trial assessing the long-term safety and efficacy of risperidone in 232 disruptive behavior disorder patients (mean age: 11.2 years; 85.3% Caucasian) previously randomized to risperidone (n=115, risperidone/risperidone) or placebo (n=117, placebo/risperidone) in a double-blind, 6-month withdrawal study (Reyes et al [2006]).54
Efficacy and safety were based upon intent-to-treat analyses. Statistical significance of between-group differences (risperidone/risperidone vs placebo/risperidone) was not evaluated. -73% of patients completed the 1-year trial (mean treatment duration: 311.5 days).
Median Dose <50 kg: 0.75 mg/day
Median Dose ≥50 kg: 1.5 mg/day
Concomitant Treatment: Included medications to treat extrapyramidal symptoms, psychotropes (other than antipsychotics; methylphenidate, n=56; dexamphetamine n=1; imipramine, n=1) and/or psychotherapy (n=16).
Safety (Baseline to Endpoint Results)
  • Overall, adverse events were mild to moderate in nature and considered to be unrelated or doubtfully related to risperidone treatment. A total of 3 risperidone/risperidone and 5 placebo/risperidone patients experienced treatment-emergent adverse events which led to risperidone discontinuation.
  • 20 patients reported serious adverse events. Of these patients, 1 case of papilledema and 1 case of abnormal vision was recorded.

Paroxysmal Perceptual Alteration


Paroxysmal Perceptual Alteration Reported During Risperidone Use
Study Design
Summary
Case Report
Pariwatcharakul and Ketumarn (2009)46 reported a case of paroxysmal perceptual alteration in a 55-year-old woman presenting 1 week following the addition of risperidone 0.5 mg/day to fluoxetine 20 mg/day for the treatment of major depressive disorder.
  • The sudden distressful visual alterations occurred twice weekly in the evening, lasted approximately 10 minutes, and were relieved by resting.
  • Neurological examination, magnetic resonance imaging, electroencephalography and blood work were normal.
  • Risperidone was increased to 1.5 mg/day since visual symptoms were regarded as psychotic. However, symptoms increased in frequency (daily). A decision to discontinue risperidone was made resulting in the resolution of visual symptoms while mood symptoms remained stable.

Xanthopsia


Xanthopsia (Yellow-Colored Vision) Reported During Risperidone Use
Study Design
Summary
Case Report
Camkurt et al (2016)38 reported a case of xanthopsia following treatment of venlafaxine 75 mg/day and low dose risperidone 1 mg/day for major depressive disorder in a 28-year-old female.
  • Two days following initiation of treatment, the patient complained of yellow discoloration in her vision.  An ophthalmologist examined her visual acuity and found it to be 20/20 in both of her eyes as well as no pathologies determined by a biomicroscopic examination.
  • Mild color blindness and minimal macular pigment epithelium changes were found when tested with Ishihara pseudoisochromatic charts and fundus examination respectively. Only risperidone was discontinued and the patient reported that she no longer experienced yellow discoloration in her vision.

OTHER RELEVANT LITERATURE

Oculogyric crisis in association with movement disorders55-59 and the effects of risperidone on saccadic eye movement abnormalities in patients with schizophrenia have been described in the literature.60-65

LITERATURE SEARCH

A literature search of Ovid MEDLINE®, Embase, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) pertaining to this topic was conducted on the 19 December 2023.

References

Show
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