SUMMARY

• Fecal incontinence was reported as an adverse reaction across placebo-controlled, active-controlled, and open-label studies of RISPERDAL and RISPERDAL CONSTA in adult and pediatric patients.^{1, 2}
• The Food and Drug Administration (FDA) is evaluating the need for regulatory action for the adverse event of fecal incontinence associated with the use of atypical antipsychotics (AAPs).³
• A retrospective study of patients with autistic disorder and mental retardation who received risperidone found that 4 patients had urinary incontinence along with fecal incontinence.⁴
• A pharmacovigilance study assessing the adverse drug reactions (ADRs) associated with AAP treatment in children and adolescents noted that 1 patient had encopresis during risperidone therapy.⁵
• There are case reports of fecal incontinence with risperidone noted in the literature. Symptoms appeared to resolve after discontinuation of risperidone.^6-9

CLINICAL DATA

Retrospective Review

Kumazaki et al (2014)⁴ conducted a retrospective review of medical records of patients with autistic disorder with mental retardation who experienced urinary incontinence following treatment with risperidone.

Study Design/Methods

• Patients diagnosed with autistic disorder with mental retardation per the DSM-IV-TR criteria who were prescribed risperidone due to behavioral problems, including hyperactivity, irritability, aggressiveness, self-injurious behavior, and stereotypes, at a hospital in Tokyo between April 1999 and March 2009 were included.
• Patients with a history of urinary incontinence before risperidone treatment were excluded.

Results

• A total of 75 patients were included, of whom, 35 had no history of urinary incontinence before risperidone use.
• After initiating treatment with risperidone, 14 patients experienced urinary incontinence, of whom, 4 experienced comorbid fecal incontinence; see Table: Data on Patients With Risperidone-Associated Urinary Incontinence and Comorbid Fecal Incontinence.

Pharmacovigilance Study

Rani et al (2009)⁵ conducted a pediatric atypical monitoring safety (PAMS) study to assess the feasibility of conducting a prospective, targeted pharmacovigilance study to monitor ADRs associated with AAP treatment in children and adolescents.

Study Design/Methods

• This study was conducted using the data on ADRs collected between September 2005 and September 2006 from secondary and tertiary pediatric/adolescent mental health inpatient and outpatient units in the United Kingdom.
• Data from clinical practitioners who initiated children and adolescents (aged ≤18 years) on treatment with new AAP were included, whereas those who did not prescribe AAP regularly (≥1 prescription every 2 months) were excluded.

Results

• A total of 281 patients were included, of whom 37 had 40 ADR reports (0.14 reports per patient; 95% confidence interval [CI], 0.10-0.19).
• One case of encopresis was reported with the use of risperidone.

Case Reports

Pediatrics and Adolescents

Aygun et al (2022)⁶ presented the case report of a 13-year-old male with attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD). Initial treatment with osmotic release oral system (OROS) methylphenidate (MPH) was started and the dose was increased based on persistent ODD symptoms. The patient was initiated on risperidone 0.5 mg/day, and the dose was increased to 1 mg/day after a week. After the dose was increased, the patient complained of daytime fecal incontinence, occurring 3-4 times/day for a week. The patient also had a history of fecal incontinence with risperidone. The drug was discontinued, and the symptoms resolved. The patient was started on aripiprazole. During the 6-month follow-up after treatment with aripiprazole and OROS MPH, the symptoms of ADHD and ODD decreased significantly without recurrence of fecal incontinence.

Cop et al (2011)⁷ described the case report of a 10-year-old male with autism who received risperidone 1 mg/day for 1 year to control agitation. This patient was referred to the child and adolescent psychiatry department of a tertiary health-care facility for side effects associated with risperidone therapy. Three weeks before admission, the patient experienced urinary and fecal incontinence along with urgency. Treatment with risperidone was discontinued, and symptoms resolved in a few days. Risperidone was reinitiated at a dose of 0.5 mg/day due to behavioral problems, which led to the recurrence of urinary and fecal incontinence, along with urgency, after a single dose. Symptoms resolved after risperidone was discontinued again. Risperidone was reinitiated for the third time at a dose of 0.25 mg/day to control agitation; the patient experienced urinary incontinence along with fecal urgency after single-dose administration. Risperidone was discontinued, and treatment with olanzapine was initiated without these side effects.

Hergüner et al (2008)⁸ presented case reports of 2 pediatric patients who developed double incontinence (urinary and fecal) during risperidone treatment.

The first case report was of a 12-year-old male patient with autistic disorder and mild mental retardation who presented to outpatient clinic for aggressive, hyperactive, and repetitive behaviors. Treatment was initiated with risperidone 1 mg/day and increased to 2 mg/day. The patient experienced double incontinence within the first week. The frequency of urinary incontinence was 5-10 times a week, during both bedtime and daytime, and that of fecal incontinence was 2-4 times a week, in the morning. No previous or family history of enuresis and encopresis was reported. Risperidone was discontinued after 5 months due to persistent double incontinence, and the patient was switched to quetiapine 200 mg/day. The symptoms of double incontinence resolved within 1 week of risperidone discontinuation. Double incontinence did not recur after 5 months of treatment with quetiapine.

The second case report was of a 16-year-old male patient with autistic disorder and moderate mental retardation who presented to outpatient clinic for severe aggressive and self-injurious behavior. Treatment was initiated with risperidone 1 mg/day and increased to 1.5 mg/day. The patient experienced double incontinence during the third week of treatment. The frequency of urinary incontinence was 1-3 times a day, during both bedtime and daytime, and that of fecal incontinence was 2-3 times a week, during daytime. No previous or family history of enuresis and encopresis was reported. Treatment with risperidone was gradually discontinued as the double incontinence lasted for 6 months, and the patient was switched to aripiprazole 15 mg/day. The symptoms of double incontinence resolved within 1 week of risperidone discontinuation. Double incontinence did not recur after 8 months of treatment with aripiprazole.

Adults

Singh et al (2019)⁹ presented the case of a 35-year-old male with complicated withdrawal delirium who had fecal incontinence during risperidone therapy. Treatment with the combined use of oral and injectable lorazepam was initiated at titrated doses. Risperidone 2 mg/day was started due to persistence of psychotic symptoms; the patient experienced 2 episodes of fecal incontinence at night and on day 4, and 10 episodes over the next 5 days, majority of which occurred in sleep. Risperidone was discontinued, and incontinence resolved after 3 days. Baclofen was initiated before discharge. A score of 5 was obtained on the Naranjo Causality Scale, suggesting a probable ADR to risperidone. The patient was readmitted after 3 days due to relapse of psychotic symptoms; risperidone and baclofen were reinitiated. Treatment was discontinued due to recurrence of incontinence. Later, baclofen was reinitiated, and incontinence did not recur. No recurring episodes of incontinence were reported at follow-up after 2 weeks.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, DERWENT Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 14 April 2023. No cases of fecal incontinence associated with RISPERDAL CONSTA were identified in the literature search.