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 Bipolar Mania
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What is bipolar mania?
Bipolar mania is a mental illness. It is part of a mental illness called bipolar I disorder.
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What is bipolar I disorder?
Bipolar I disorder is a mood disorder. It is characterized by dramatic swings in mood and energy levels. People with bipolar I disorder alternate between phases or episodes of mania (intense “highs”) and depression (dramatic “lows”). Sometimes, people may experience a “ mixed” episode, a combination of manic and depressive symptoms. The moods associated with bipolar I disorder are much more exaggerated than the simple “ups and downs” most people experience, and if left untreated, may affect your ability to function effectively.
Bipolar I disorder can sometimes disrupt your life and your relationships with both family and friends. There is no cure for the illness, symptoms of bipolar I disorder can be successfully treated in many cases. With medication, psychosocial counseling and strong support systems, people with bipolar I disorder may stabilize their moods. However, it is important to remember that this illness is chronic and may require lifelong treatment and management.
For more information on bipolar disorder, please visit the National Institute on Mental Health Web site
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What are some symptoms of bipolar mania?
People who have bipolar I disorder may experience episodes of mania or mixed episode.
Manic Episode
A manic episode is defined as a period during which people are in a highly elevated, expansive, irritable, or angry mood, which lasts at least 1 week.
Symptoms of mania may include:
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Unrealistic beliefs in one’s ability – exaggerated confidence
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Excessive energy, activity, restlessness
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Decreased need for sleep
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Racing thoughts, rapid talking
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Uncharacteristically poor judgment – reckless driving, spending sprees, foolish business ventures
In severe cases of mania, people may also experience hallucinations (hearing voices and seeing things that are not there) and delusions (beliefs in ideas that are obviously false).
Mixed Episode
Patients may also experience a mixed episode, which is characterized by the manic symptoms described above in addition to depressive symptoms listed below.
Symptoms of depression may include:
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Feeling sad, anxious, empty, guilty, hopeless, or worthless
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Sleeping or eating too much or too little
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Loss of interest or pleasure in activities, including sex
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Difficulty concentrating, remembering, or making decisions
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Fatigue or loss of energy
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Physical symptoms that don’t respond to treatment (eg, chronic pain or digestive disorders)
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What causes bipolar mania or bipolar I disorder?
No one knows for sure what causes bipolar I disorder or bipolar mania. It is believed that the illness is caused by chemical imbalances in the brain. These chemicals carry messages between your brain cells. Scientists believe an imbalance of these chemicals may cause mood swings. These chemicals may include dopamine and serotonin .
While stress may trigger an episode of mania or depression, it is not a cause of the illness. People with bipolar I disorder may be more susceptible to physical and emotional factors such as changes in sleep.
Like high cholesterol and other medical conditions, bipolar I disorder tends to run in families. People who have a relative with bipolar I disorder are more likely to develop the illness than those who do not. People with a family history of mental illness have a greater chance of developing it, which means there may be a genetic link to at least some cases of bipolar I disorder.
Whatever the cause, it is important to understand that you did not bring the illness on yourself. It's equally important to remember that with proper treatment people can learn to live with bipolar I disorder and have a full and rewarding life.
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What is a manic episode?
A manic episode (return of symptoms) can be triggered anytime. People with bipolar I disorder can sometimes experience mood swings/changes even if they have been taking their medication as prescribed.
It is important that you learn to watch for the early warning signs of an episode. These include:
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Feeling so good or so hyper that other people think you are not your normal self or you are so hyper that you got into trouble
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You are so irritable that you shout at people or start fights or arguments
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You feel much more self-confident than usual
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You get much less sleep than usual and find that you don’t really miss it
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You are much more talkative or speak much faster than usual
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Thoughts race through your head or you can’t slow your mind down
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You are so easily distracted by things around you that you have trouble concentrating or staying on track
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You have much more energy than usual
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You are much more active or do many more things than usual
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You are much more social or outgoing than usual; for example, you telephone friends in the middle of the night
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You are much more interested in sex than usual
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You do things that are unusual for you or that other people might think are excessive, foolish, or risky
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You spend so much money that it gets you or your family into trouble
If you notice changes in your mood, you should report them immediately to your healthcare professional so that you can be treated before a full-blown mania episode occurs.
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What is RISPERDAL®?
RISPERDAL® (risperidone) is a prescription medication that has been approved by the Food and Drug Administration (FDA) for the treatment of mania associated with bipolar I disorder. It has been proven effective for use as therapy alone or in combination with drugs called mood stabilizers, (such as lithium or valproate).
In clinical trials, RISPERDAL® either alone or combined with a mood stabilizer (valproate or lithium) was highly effective in improving manic symptoms compared to placebo (sugar pill) and a mood stabilizer. Your results may vary.
For people who have trouble swallowing pills, RISPERDAL® is also available in an oral liquid and as a rapidly disintegrating tablet (called RISPERDAL® M-Tab®*).
* RISPERDAL® M-TAB® contains phenylalanine. It should not be taken by people who have been diagnosed with PKU (phenylketonuria).
Remember, RISPERDAL® may not be right for all people with bipolar mania. Be sure to talk with your healthcare professional.
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What are the available doses of RISPERDAL®?
RISPERDAL® (risperidone) is available in a variety of formulations and strengths. This allows your doctor to prescribe the formulation and dose that's most appropriate and convenient for you. RISPERDAL® is available as:
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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
* RISPERDAL® M-TAB® contains phenylalanine. It should not be taken by people who have been diagnosed with PKU (phenylketonuria).
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What is RISPERDAL® M-TAB® (risperidone)?
RISPERDAL® M-TAB®* is a rapidly disintegrating tablet formulation of RISPERDAL® with added convenience:
- Disintegrates in the mouth within seconds
- Easy to swallow (does not require a beverage to be taken)
- 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 does RISPERDAL® work?
The symptoms of bipolar mania are thought to be caused by chemical imbalances in the brain (either too high or too low). These chemicals are called dopamine and serotonin. Although it is unclear as to exactly how RISPERDAL® works, it seems to help balance the chemicals in the brain called dopamine and serotonin. While it's not a cure, RISPERDAL® may help you to manage your symptoms.
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When can I expect to feel better with RISPERDAL®?
For some people, RISPERDAL® can start working soon after initiating therapy. However, it may take the full course of therapy to get the full benefit of your medication. So please be patient and give RISPERDAL® a chance to take effect. If you are still experiencing symptoms or have questions call your healthcare professional.
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What side effects might I encounter with RISPERDAL®?
RISPERDAL®(risperidone) has some possible side effects that you should know about.
With any medication, some people have side effects and some don't. If you have any side effects with RISPERDAL®, or feel you're not getting better, please talk to your healthcare professional. Your healthcare professional may adjust the dose to help reduce or minimize your side effects.
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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Should RISPERDAL® be taken with or without food?
RISPERDAL® may be taken conveniently with or without food.
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How should RISPERDAL® be stored?
RISPERDAL® M-TAB®, RISPERDAL® Tablets, and RISPERDAL® Oral Solution 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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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. Avoid alcohol while taking RISPERDAL.
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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 ingredient.
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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.
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