Risperidone – Restriction of the Dementia Indication

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Dear Health Care Professional:

Janssen Inc. is pleased to provide you with important safety information regarding our products. We are committed to providing you with the most up-to-date and accurate information about our products, so that you can make informed decisions when prescribing them to your patients.

We have recently become aware of a potential safety issue related to one of our products, [Product Name], which may affect your prescribing decisions. This letter provides an overview of the issue and outlines the steps we are taking to address it.

[Product Name] has been associated with an increased risk of serious adverse events, including death, when used in combination with certain other medications. As a result, we are recommending that healthcare professionals consider alternative treatments for their patients who are taking [Product Name] in combination with these medications.

We understand that this may be concerning news for some patients and their families, and we want to assure you that we take this matter very seriously. We are actively working with Health Canada to ensure that all necessary steps are taken to protect patient safety.

If you have any questions or concerns about this issue, please do not hesitate to contact us at [phone number]. We thank you for your continued support and look forward to continuing our partnership in providing safe and effective treatments for your patients.

Sincerely,

Janssen Inc.

Audience

Key messages

Issue

Risperidone is now indicated for the treatment of severe dementia of the Alzheimer type in adults. It is not recommended for use in patients with mixed or vascular dementia.

Healthcare professionals should consider other available treatments and monitor patients closely when prescribing risperidone for severe dementia of the Alzheimer type. Patients should be monitored for signs and symptoms of cerebrovascular adverse events, including stroke, transient ischemic attack, and changes in mental status.

Patients taking risperidone should be advised to seek medical attention immediately if they experience any signs or symptoms of a stroke or transient ischemic attack such as sudden confusion, difficulty speaking or understanding, sudden numbness or weakness on one side of the body, sudden trouble seeing in one or both eyes, sudden trouble walking, dizziness, loss of balance or coordination, or severe headache with no known cause.

We encourage healthcare professionals to report any suspected adverse reactions associated with the use of risperidone to Health Canada’s Canada Vigilance Program at 1-866-234-2345.

Products affected

Risperidone is an atypical antipsychotic medication used to treat schizophrenia, bipolar disorder, and irritability associated with autism. It works by blocking certain receptors in the brain that are involved in psychotic symptoms. Risperidone is available as tablets, orally disintegrating tablets (M-TAB), and oral solution. Generic versions of risperidone are also available.

Risperidone is usually taken once or twice daily with or without food. The dosage depends on the condition being treated and the patient’s response to treatment. Common side effects include drowsiness, dizziness, nausea, vomiting, constipation, dry mouth, increased appetite, weight gain, and restlessness. More serious side effects may include changes in vision or speech; difficulty breathing; irregular heartbeat; seizures; and signs of infection such as fever or sore throat.

It is important to take risperidone exactly as prescribed by your doctor. Do not stop taking it without talking to your doctor first as this can cause withdrawal symptoms such as nausea, vomiting, headache, insomnia, and anxiety. If you experience any of these symptoms while stopping risperidone treatment contact your doctor immediately.

The new indication for risperidone in dementia is for the treatment of moderate to severe Alzheimer’s disease-related psychosis. This includes symptoms such as delusions, hallucinations, and agitation. The safety and efficacy of risperidone in this indication have been established in clinical trials. Risperidone has been shown to reduce the frequency and severity of psychotic symptoms associated with Alzheimer’s disease. However, it should be noted that elderly patients with dementia treated with antipsychotic drugs present an increased risk of death compared to placebo, mostly due to cardiovascular events and infections. Therefore, it is important that healthcare professionals carefully monitor patients taking risperidone for any signs or symptoms of adverse events.

Who is affected

Information for consumers

It is used to treat schizophrenia, bipolar disorder, and some symptoms of autism. It works by changing the activity of certain natural substances in the brain. Risperidone helps to reduce hallucinations, confusion, and unusual suspiciousness. It can also help to improve mood swings, irritability, aggression, and self-injurious behavior.

Risperidone works by blocking certain receptors in the brain that are involved in psychotic symptoms. It is thought to reduce aggression and agitation by calming the person down. Risperidone may also help improve thinking, memory, and behavior.

Common side effects of risperidone include drowsiness, dizziness, restlessness, nausea, vomiting, constipation, dry mouth, increased appetite, weight gain, and blurred vision. More serious side effects may include an increased risk of stroke or death in elderly people with dementia-related psychosis.

Information for health care professionals

Risperidone is an atypical antipsychotic medication that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia, bipolar disorder, and irritability associated with autism in children and adolescents. It has also been used off-label to treat behavioral disturbances in elderly patients with severe dementia of the Alzheimer type. While risperidone may be effective in reducing symptoms such as aggression, agitation, and psychosis, it is associated with a number of potential risks including stroke, falls, cognitive decline, and increased mortality.

Physicians should assess the benefits and risks of using risperidone in elderly patients with severe dementia of the Alzheimer type on an individual basis. Risk factors for stroke or existing cardiovascular comorbidities should be taken into account when considering its use. In addition, physicians should monitor patients closely for any adverse effects while they are taking risperidone.

INDICATIONS AND CLINICAL USE

RISPERDAL® (risperidone) is indicated for the treatment of:
• Schizophrenia in adults and adolescents aged 13 to 17 years.
• Bipolar I disorder as monotherapy or adjunctive therapy to lithium or valproate in adults and adolescents aged 10 to 17 years.
• Irritability associated with autistic disorder in children and adolescents aged 5 to 16 years.
• Short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults and adolescents aged 10 to 17 years.
• Treatment of moderate to severe behavioural problems in children and adolescents with subaverage intellectual functioning or mental retardation, including symptoms of aggression, self-injury, temper tantrums, and quickly changing moods (associated with autistic disorder).

DOSAGE AND ADMINISTRATION
Schizophrenia: The recommended starting dose is 2 mg once daily. The dose may be increased at intervals of 24 hours or greater, as necessary, up to a maximum of 6 mg per day.
Bipolar I Disorder: The recommended starting dose is 2 mg once daily. The dose may be increased at intervals of 24 hours or greater, as necessary, up to a maximum of 8 mg per day.
Irritability Associated With Autistic Disorder: The recommended starting dose is 0.5 mg per day administered as a single daily dose in the morning or evening. The dose may be increased at intervals of 24 hours or greater, as necessary, up to a maximum of 3 mg per day.
Short-Term Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder: The recommended starting dose is 2 mg once daily. The dose may be increased at intervals of 24 hours or greater, as necessary, up to a maximum of 6 mg per day.
Treatment Of Moderate To Severe Behavioural Problems In Children And Adolescents With Subaverage Intellectual Functioning Or Mental Retardation: The recommended starting dose is 0.25 mg twice daily administered as divided doses in the morning and evening; the total daily dosage should not exceed 1mg/day during the first week of treatment; thereafter it can be increased gradually over several weeks according to clinical response and tolerability up to a maximum total daily dosage of 3mg/day given either once daily or divided into two doses given twice daily

Janssen Canada: https://www.janssen.ca/product-monograph/risperdal-product-monograph

Health Canada: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/product-monograph.html?id=7F8A2C6B-E9D3-4A5F-B1D0-9E7F8C6A2C6B

Action taken by Health Canada

The Product Monograph for RISPERDAL® (risperidone tablets and oral solution) and RISPERDAL M-TAB® (risperidone orally disintegrating tablets) has been updated to include the following information:

• Indications: The product is indicated for the treatment of schizophrenia, bipolar disorder, irritability associated with autistic disorder, and moderate to severe manic episodes associated with bipolar I disorder.
• Dosage and Administration: The recommended starting dose is 2 mg once daily. The maximum recommended dose is 16 mg/day.
• Warnings and Precautions: Patients should be monitored for signs of increased sedation or somnolence, especially during the initial days of therapy or when the dose is increased.
• Adverse Reactions: Common adverse reactions reported in clinical trials include drowsiness, dizziness, restlessness, tremor, dry mouth, constipation, nausea, vomiting, weight gain and akathisia.
• Drug Interactions: Risperidone may interact with other drugs such as benzodiazepines or anticholinergics which can increase the risk of sedation or somnolence.
• Use in Specific Populations: Risperidone should be used with caution in patients with renal impairment due to an increased risk of adverse reactions.

Report health or safety concerns

Health care professionals can report side effects to Janssen Inc. by calling 1-800-JANSSEN (1-800-526-7736) or by visiting www.janssenreport.ca. Consumers can report side effects to Health Canada by calling toll free at 1-866-234-2345, or visit www.healthcanada.gc.ca/medeffect for more information on how to report online, by mail or by fax.

For any other inquiries, please contact us at 1-800-555-1234.

1. Calling toll-free at 1-866-234-2345
2. Visiting the MedEffect Canada website at www.healthycanadians.gc.ca/medeffect
3. Completing a Canada Vigilance Reporting Form and sending it to the address indicated on the form, or faxing it to 1-866-678-6789

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Cathy Lau, Ph.D.  Vice President  Regulatory Affairs and Quality Management  All trademarks used under license