Janssen Pharmaceuticals, Inc. is initiating a voluntary recall of one lot of RISPERDAL® (risperidone) 3mg Tablets, marketed by Janssen Pharmaceuticals, Inc. and one lot of risperidone 2mg Tablets, marketed by Patriot Pharmaceuticals, LLC, a wholly owned subsidiary of Janssen Pharmaceuticals, Inc. Click here for Urgent Drug Product Recall letter sent to wholesalers, distributors and pharmacists. Patient questions about the June 2011 voluntary recall should be discussed with your healthcare professional.
Frequently Asked Questions about Autistic Disorder
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What is Autistic Disorder?
Autistic disorder is a developmental disability that affects a person's ability to communicate, form relationships with others, and respond appropriately to his or her environment. It begins in childhood and is thought to be a lifelong disorder.
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What Are the Symptoms of Autistic Disorder?
Some of the symptoms associated with autistic disorder may vary among individuals; but generally, people with autistic disorder tend to have social, communication, motor and sensory impairments that affect their behavior.
For more information on autistic disorder, please visit the National Institute of Mental Health Web site and RisperdalAutism.com.
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What Causes Autistic Disorder?
No one knows exactly what causes autistic disorder, but scientists think that both genetic and environmental factors might play a role.
4 Recent research shows that autistic disorder is related to abnormalities in brain structures or functions. Studies are ongoing to examine whether autistic disorder affects specific areas of the brain or if there are problems with the transmission of signals from one part of the brain to another.5 Some studies in identical twins suggest that autistic disorder can be inherited. Currently, scientists are researching irregularities in genetic codes and specific genes to determine the role that heredity might play in autistic disorder.
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How Is Autistic Disorder Diagnosed?
Parents usually are the first to identify unusual behavior in their child during infancy, such as unresponsiveness to sound or not making eye contact. In other cases, parents may notice their child has regressed or stopped meeting developmental milestones.
6 Diagnosis typically involves a developmental screening during a "well child" check-up followed by a comprehensive evaluation by a multidisciplinary team. A diagnosis requires a problem in at least one area of either communication, socialization, or restricted behavior before the age of 3 years.
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What Are the Treatment Options?
There is no single best treatment for individuals with autistic disorder. Experts agree that early identification and intervention are important and that children with autistic disorder respond well to participating in highly structured, specialized programs.
7 The child's parents or caregivers in collaboration with his or her physician or other healthcare professional should determine the best approach to treatment.A number of treatment approaches have been identified. Some approaches focus on developing skills and learning appropriate behaviors. Other approaches are reward-based using positive reinforcement to encourage children to practice certain skills.
RISPERDAL® (risperidone) is approved for the treatment of irritability associated with autistic disorder in children and adolescents ages 5-16 years. RISPERDAL® is not used to treat the core symptoms of autism. For more information, click here to review the Important Product Information.
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What is RISPERDAL® (risperidone)?
RISPERDAL® is a prescription medication indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.
For more information on autistic disorder, please visit the National Institute of Mental Health Web site and RisperdalAutism.com.
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What are the available doses of RISPERDAL®?
RISPERDAL® has convenient, flexible dosing allowing it to be prescribed in different formulations to best meet personal preferences and in different strengths to best manage individual symptoms. The healthcare professional will determine which formulation and strength is right.
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Rapidly disintegrating tablets, known as
RISPERDAL® M-TAB® - 5 strengths
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Oral tablets - 6 strengths
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Oral liquid
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What is RISPERDAL® M-TAB® (risperidone)?
RISPERDAL® M-TAB® is a rapidly disintegrating tablet formulation of RISPERDAL® with added convenience:
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Disintegrates in the mouth within seconds
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Easy to swallow (does not require a beverage to be taken)
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Mint flavored
* RISPERDAL® M-TAB® contains phenylalanine. It should not be taken by people who have been diagnosed with PKU (phenylketonuria).
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How soon can the patient expect to see improvement?
In clinical trials significant improvement was observed in many children and adolescents with irritability associated with autism at eight (8) weeks. Irritability was measured using the Aberrant Behavior Checklist (ABC)*
* Aberrant Behavior Checklist (ABC): a standardized checklist designed to measure behavioral problems in children with developmental disabilities. The checklist is made up of 5 subscales (Irritability, Lethargy and Social Withdrawal, Stereotypic Behavior, Hyperactivity/Noncompliance, and Inappropriate Speech); higher subscale scores indicate increased symptom severity. The ABC-Irritability (ABC-I) subscale was the primary outcome measure used in the RISPERDAL® clinical trials.
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What are the side effects of RISPERDAL®?
RISPERDAL® (risperidone) has some possible side effects that you should know about.
If the individual taking RISPERDAL® has any side effects with RISPERDAL®, or does not seem to be getting better, please talk to the healthcare professional.
Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.
The most common adverse reactions observed in all clinical trials with RISPERDAL® occurring at a rate of at least 10% were somnolence, increased appetite, fatigue, rhinitis, upper respiratory tract infection, vomiting, coughing, urinary incontinence, increased saliva, constipation, fever, tremors, muscle stiffness, abdominal pain, anxiety, nausea, dizziness, dry mouth, rash, restlessness, and indigestion.
Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL® and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.
Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL® and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.
RISPERDAL® and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection. The connection between prolactin levels and side effects is unknown.
High blood sugar and diabetes have been reported with RISPERDAL® and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment. Complications of diabetes can be serious and even life threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.
RISPERDAL® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.
Some people taking RISPERDAL® may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional's dosing instructions, this side effect may be reduced or it may go away over time.
Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.
Some medications interact with RISPERDAL®. Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while taking RISPERDAL®.
Inform your healthcare professional if you are pregnant or if you are planning to get pregnant while taking RISPERDAL®. Do not breast-feed if you are taking RISPERDAL®.
RISPERDAL® may affect your driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.
RISPERDAL® may affect alertness and motor skills; use caution until the effect of RISPERDAL® is known.
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How should RISPERDAL® be stored?
RISPERDAL® Tablets, RISPERDAL® Oral Solution, and
RISPERDAL® M-TAB® , should be stored at controlled room temperature(59-77°F/15-25°C) , away from children, and should be protected from light and moisture. RISPERDAL® Oral Solution should be protected from light and freezing temperatures.
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Should RISPERDAL® be taken with or without food?
RISPERDAL® may be taken conveniently with or without food.
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Can RISPERDAL® Oral Solution be taken with all beverages?
No. RISPERDAL® is compatible with water, orange juice, coffee, and low fat milk. RISPERDAL® Oral Solution should not be taken with tea or cola because these beverages will make the medication less effective.
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Does RISPERDAL® contain latex?
No. RISPERDAL® Oral Solution, Tablets and M-TAB® do not contain latex. Janssen Pharmaceuticals, Inc. cannot, however, discount any inadvertent exposure of our products (for example, contact with latex gloves) during manufacturing or processing operations.
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Does RISPERDAL® contain gluten?
Patients who must adhere to a gluten-free diet must avoid products that contain wheat, rye, oats, or barley. RISPERDAL Tablets and RISPERDAL® Oral Solution contain none of these ingredients. However, gluten may be a component of the protein present in cornstarch (which is approximately 0.3% protein), which is contained in RISPERDAL Tablets. RISPERDAL® M-TAB® does contain bovine – animal source gelatin, plus two synthetic carbohydrates but these components do not have gluten content such as what is contained in wheat-based ingredients.
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Are RISPERDAL® Tablets kosher?
RISPERDAL® Tablets contain no alcohol but do contain animal products in the form of lactose (from cow's milk). They also contain cornstarch. RISPERDAL M-TAB® contains gelatin that is bovine-sourced (i.e. from cattle) and is certified to be BSE-free.
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Does RISPERDAL® contain aspartame?
Only RISPERDAL® M-TAB® contains aspartame.
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Does RISPERDAL® contain phenylalanine?
Only RISPERDAL® M-TAB® contains phenylalanine.
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Is there a patient assistance program for RISPERDAL®?
Yes, Janssen Pharmaceuticals, Inc. provides assistance with RISPERDAL® to patients who, because of financial burden and lack of prescription drug coverage, may have difficulty paying for their treatment.
The Patient Assistance Program is designed to make our products available free of charge to persons who have a medical need and meet specific financial criteria. It is important to note that our patient assistance programs provide assistance when no source of prescription drug coverage is available.
Please visit access2wellness.com.
For more information about autistic disorder, please visit:
| 1 |
Centers for Disease Control and Prevention. About Autism. Available
at:
www.cdc.gov/ncbddd/autism/index.htm. Accessed October 22, 2008. |
| 2 | Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington,D.C.: American Psychiatric Association;1954 |
| 3 | Bertrand J., Mars A., Boyle C., Bove F., Yeargin-Allsopp M., Decoufle P. Prevalence of autism in the United States population: the Brick Township, New Jersey, investigation. Pediatrics. 2001;108;1155-61 |
| 4 |
Centers for Disease Control and Prevention. "Autism Spectrum
Disorders Overview" Available at:
www.cdc.gov/ncbddd/autism/overview.htm. Accessed September 26, 2007. |
| 5 | National Institute of Mental Health. "Research into Causes and Treatment of Autism Spectrum Disorders" Available at: www.nimh.nih.gov/health/publications/autism/research.shtml. Accessed: September 26, 2007. |
| 6 | National Institute of Mental Health. "The Diagnosis of Autism Spectrum Disorders" Available at: www.nimh.nih.gov/health/publications/autism/diagnosis.shtml. Accessed: October 22, 2008. |
| 7 | National Institute of Mental Health. "Treatment Options" Available at: www.nimh.nih.gov/health/publications/autism/treatment.shtml. Accessed: September 26, 2007. |
| 8 | National Institute of Mental Health. "The Numbers Count: Mental Disorders in America" Available at: www.nimh.nih.gov/health/publications/the-numbers-count-mental-disorders-in-america.shtml. Accessed: October 22, 2008. |
