Why do people take abilify

Abilify Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Warnings:

If you are using aripiprazole in combination with other medication to treat depression, also carefully read the drug information for the other medication.

There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

Warnings:

If you are using aripiprazole in combination with other medication to treat depression, also carefully read the drug information for the other medication.

Uses

Aripiprazole is used to treat certain mental/mood disorders (such as bipolar disorder, schizophrenia, Tourette's syndrome, and irritability associated with autistic disorder). It may also be used in combination with other medication to treat depression. Aripiprazole is known as an antipsychotic drug (atypical type). It works by helping to restore the balance of certain natural chemicals in the brain (neurotransmitters).This medication can decrease hallucinations and improve your concentration. It helps you to think more clearly and positively about yourself, feel less nervous, and take a more active part in everyday life. Aripiprazole can treat severe mood swings and decrease how often mood swings occur.

How to use Abilify

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking aripiprazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

The manufacturer directs to swallow this medication whole. However, many similar drugs (immediate-release tablets) can be split/crushed. Follow your doctor's direction on how to take this medication.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/cup. Do not use a household spoon because you may not get the correct dose.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

It may take several weeks before you get the full benefit of this drug. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Precautions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: metoclopramide.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

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Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very fast heartbeat, loss of consciousness.

Do not share this medication with others.

Laboratory and/or medical tests (such as blood sugar, weight, cholesterol/triglyceride levels) may be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store the tablet and the oral liquid at room temperature away from light and moisture. Discard the oral solution 6 months after opening or after the expiration date, whichever comes first. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Aripiprazole (Abilify) | NAMI: National Alliance on Mental Illness

Brand names:

- Abilify MyCite®
  - Oral tablet with a digestible sensor: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg
- Abilify Maintena®
  - Extended-release injectable suspension: 300 mg, 400 mg
- Aristada® (aripiprazole lauroxil)
  - Extended-release injectable suspension: 441 mg, 662 mg, 882 mg, 1064 mg
- Aristada Initio® (aripiprazole lauroxil)
  - Extended-release injectable suspension: 675 mg
Generic name: aripiprazole (ay ri PIP ray zole), aripiprazole lauroxil (law rox il)
- Aripiprazole
  - Oral tablet: 2 mg, 5mg, 10 mg, 15 mg, 20 mg, 30 mg
  - Orally disintegrating tablet: 10 mg, 15 mg
  - Oral solution: 1 mg/mL
All FDA black box warnings are at the end of this fact sheet. Please review before taking this medication.
What Is Aripiprazole And What Does It Treat?
Aripiprazole is a medication that works in the brain to treat schizophrenia. It is also known as a second-generation antipsychotic (SGA) or atypical antipsychotic. Aripiprazole rebalances dopamine and serotonin to improve thinking, mood, and behavior.
Symptoms of schizophrenia include:
- Hallucinations – imagined voices or images that seem real
- Delusions - beliefs that are not true (e.g., other people are reading your thoughts)
- Disorganized thinking or trouble organizing your thoughts and making sense
- Little desire to be around other people
- Trouble speaking clearly
- Lack of motivation
Aripiprazole may help some or all of these symptoms.
Aripiprazole is also FDA approved for the following indications:
- Acute treatment of manic or mixed episodes of bipolar disorder (when used alone or with lithium or valproate)
- Maintenance (long-term) treatment of bipolar disorder
- Adjunctive treatment of major depressive disorder. This means aripiprazole is used in addition to an antidepressant to help treat depression.
- Irritability associated with autistic disorders
- Tourette’s syndrome
This medication sheet will focus primarily on schizophrenia. You can find more information about bipolar disorder, depression, and autism spectrum disorders here.
Aripiprazole may also be helpful when prescribed “off-label” for borderline personality disorder or drug-induced hyperprolactinemia (elevated prolactin levels caused by other antipsychotics). “Off-label” means that it hasn’t been approved by the Food and Drug Administration for this condition. Your mental health provider should justify his or her thinking in recommending an “off-label” treatment. They should be clear about the limits of the research around that medication and if there are any other options.
What Is The Most Important Information I Should Know About Aripiprazole?
Schizophrenia requires long-term treatment. Do not stop taking aripiprazole, even when you feel better.
With input from you, your health care provider will assess how long you will need to take the medicine.
Missing doses of aripiprazole may increase your risk for a relapse in your symptoms.
Do not stop taking aripiprazole or change your dose without talking with your health care provider first.
For aripiprazole to work properly, it should be taken every day as ordered by your health care provider.
Are There Specific Concerns About Aripiprazole And Pregnancy?
If you are planning on becoming pregnant, notify your health care provider to best manage your medications. People living with schizophrenia who wish to become pregnant face important decisions. This is a complex decision since untreated schizophrenia has risks to the fetus, as well as the mother. It is important to discuss the risks and benefits of treatment with your doctor and caregivers.
Antipsychotic use during the third trimester of pregnancy has a risk for abnormal muscle movements (extrapyramidal symptoms [EPS]) and/or withdrawal symptoms in newborns following delivery. Symptoms in the newborn may include agitation, feeding disorder, hypertonia, hypotonia, respiratory distress, somnolence, and tremor; these effects may be self-limiting or require hospitalization.
In general, infants exposed to SGAs via breast milk should be monitored weekly for the first month of exposure for symptoms, such as appetite changes, insomnia, irritability, or lethargy.
Caution is advised with breastfeeding since aripiprazole does pass into breast milk.
What Should I Discuss With My Health Care Provider Before Taking Aripiprazole?
- Symptoms of your condition that bother you the most
- If you have thoughts of suicide or harming yourself
- Medications you have taken in the past for your condition, whether they were effective or caused any adverse effects
- If you ever had muscle stiffness, shaking, tardive dyskinesia, neuroleptic malignant syndrome, or weight gain caused by a medication
- If you experience side effects from your medications, discuss them with your provider. Some side effects may pass with time, but others may require changes in the medication.
- Any psychiatric or medical problems you have, such as heart rhythm problems, long QT syndrome, heart attacks, diabetes, high cholesterol, or seizures
- If you have a family history of diabetes or heart disease
- All other medications you are currently taking (including over the counter products, herbal and nutritional supplements) and any medication allergies you have
- Other non-medication treatment you are receiving, such as talk therapy or substance abuse treatment. Your provider can explain how these different treatments work with the medication.
- If you are pregnant, plan to become pregnant, or are breastfeeding
- If you smoke, drink alcohol, or use illegal drugs
How Should I Take Aripiprazole?
Aripiprazole tablets and suspension are usually taken 1 time per day with or without food.
Typically, patients begin at a low dose of medicine and the dose is increased slowly over several weeks.
The oral dose of aripiprazole usually ranges from 2 mg to 30 mg taken once daily. The dose of aripiprazole maintena extended-release injection ranges from 300 mg to 400 mg given once monthly; the dose of aripiprazole lauroxil extended-release injection ranges from 441 mg to 1064 mg – depending on the dose, it is given once per month, every 6 weeks, or every 2 months. Aripiprazole Maintena requires a two-week oral medication overlap; aripiprazole lauroxil requires a three-week oral overlap. Aripiprazole lauroxil Initio is typically given after an oral dose of aripiprazole along with an aripiprazole lauroxil injection – this allows for a one-day initiation and does not require further oral overlap. Only your health care provider can determine the correct formulation and dose for you.
Use a calendar, pillbox, alarm clock, or cell phone alert to help you remember to take your medication. You may also ask a family member or a friend to remind you or check in with you to be sure you are taking your medication.
What Happens If I Miss A Dose Of Aripiprazole?
If you miss a dose of oral aripiprazole, take it as soon as you remember, unless it is closer to the time of your next dose. Do not double your next dose or take more than what is prescribed. If you miss an injection, call your doctor or pharmacist right away. Discuss this with your health care provider.
What Should I Avoid While Taking Aripiprazole?
Avoid drinking alcohol or using illegal drugs while you are taking aripiprazole. They may decrease the benefits (e.g., worsen your confusion) and increase adverse effects (e.g., sedation) of the medication.
What Happens If I Overdose With Aripiprazole?
If an overdose occurs call your doctor or 911. You may need urgent medical care. You may also contact the poison control center at 1-800-222-1222.
A specific treatment to reverse the effects of aripiprazole does not exist.
What Are Possible Side Effects Of Aripiprazole?
Common side effects
Headache, extrapyramidal symptoms, drowsiness, restlessness, fatigue, sedation, agitation, insomnia, anxiety, weight gain, cholesterol abnormalities, increased glucose, nausea, vomiting, constipation, application site rash (MyCite), tremor
Rare/serious side effects
Rash, dry mouth, muscle aches, seizure, agitation
Aripiprazole may increase the blood levels of a hormone called prolactin. Side effects of increased prolactin levels include females losing their period, production of breast milk and males losing their sex drive or possibly experiencing erectile problems. Long term (months or years) of elevated prolactin can lead to osteoporosis or increased risk of bone fractures.
Some people may develop muscle-related side effects while taking aripiprazole. The technical terms for these are “extrapyramidal symptoms” (EPS) and “tardive dyskinesia” (TD). Symptoms of EPS include restlessness, tremor, and stiffness. TD symptoms include slow or jerky movements that one cannot control, often starting in the mouth with tongue rolling or chewing movements.
Temperature regulation: Impaired core body temperature regulation may occur; caution with strenuous exercise, heat exposure, and dehydration.
Second generation antipsychotics (SGAs) increase the risk of weight gain, high blood sugar, and high cholesterol. This is also known as metabolic syndrome. Your health care provider may ask you for a blood sample to check your cholesterol, blood sugar, and hemoglobin A1c (a measure of blood sugar over time) while you take this medication.
- Information on healthy eating and adding exercise to decrease your chances of developing metabolic syndrome may be found at the following sites:
  - http://www.helpguide.org/articles/healthy-eating/healthy-eating.htm
  - http://www.helpguide.org/home-pages/exercise-fitness.htm
SGAs have been linked with higher risk of death, strokes, and transient ischemic attacks (TIAs) in elderly people with behavior problems due to dementia.
All antipsychotics have been associated with the risk of sudden cardiac death due to an arrhythmia (irregular heart beat). To minimize this risk, antipsychotic medications should be used in the smallest effective dose when the benefits outweigh the risks. Your doctor may order an EKG to monitor for irregular heartbeat.
Neuroleptic malignant syndrome is a rare, life threatening adverse effect of antipsychotics which occurs in <1% of patients. Symptoms include confusion, fever, extreme muscle stiffness, and sweating. If any of these symptoms occur, contact your health care provider immediately.
All antipsychotics can cause sedation, dizziness, or orthostatic hypotension (a drop in blood pressure when standing up from sitting or lying down). These side effects may lead to falls which could cause bone fractures or other injuries. This risk is higher for people with conditions or other medications that could worsen these effects. If falls or any of these symptoms occur, contact your health care provider.
The U.S. Food and Drug Administration (FDA) is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of aripiprazole (Abilify, Abilify Maintena, Aristada, Aristada Initio). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized.
Are There Any Risks For Taking Aripiprazole For Long Periods Of Time?
Tardive dyskinesia (TD) is a side effect that develops with prolonged use of antipsychotics. Medications such as aripiprazole have been shown to have a lower risk of TD compared to older antipsychotics, such as Haldol® (haloperidol). If you develop symptoms of TD, such as grimacing, sucking, and smacking of lips, or other movements that you cannot control, contact your health care provider immediately. All patients taking either first or second generation antipsychotics should have an Abnormal Involuntary Movement Scale (AIMS) completed regularly by their health care provider to monitor for TD.
Second generation antipsychotics (SGAs) increase the risk of diabetes, weight gain, high cholesterol, and high triglycerides. (See “Serious Side Effects” section for monitoring recommendations).
What Other Medications May Interact With Aripiprazole?
The following medications may increase the levels and effects of aripiprazole:
- The antibiotic clarithromycin (Biaxin®)
- Antidepressants, such as fluoxetine (Prozac®), paroxetine (Paxil®), and nefazodone
- Antifungals, such as fluconazole (Diflucan®), ketoconazole (Nizoral®), and itraconazole (Sporanox®)
- The antiarrhythmic agent quinidine
- HIV medications, such as the protease inhibitors indinavir (Crixivan®), ritonavir (Norvir®), saquinavir (Fortovase®, Invirase®), and lopinavir/ritonavir (Kaletra®)
The following medications may decrease the levels and effects of aripiprazole: carbamazepine (Tegretol®) and rifampin (Rifadin®).
How Long Does It Take For Aripiprazole To Work?
It is very important to tell your doctor how you feel things are going during the first few weeks after you start taking aripiprazole. It will probably take several weeks to see big enough changes in your symptoms to decide if aripiprazole is the right medication for you.
Antipsychotic treatment is generally needed lifelong for persons with schizophrenia. Your doctor can best discuss the duration of treatment you need based on your symptoms and illness.
- Hallucinations, disorganized thinking, and delusions may improve in the first 1-2 weeks
- Sometimes these symptoms do not completely go away
- Motivation and desire to be around other people can take at least 1-2 weeks to improve
- Symptoms continue to get better the longer you take aripiprazole
- It may take 2-3 months before you get the full benefit of aripiprazole
Summary of FDA Black Box Warnings
Increased mortality in elderly patients with dementia related psychosis
- Both first generation (typical) and second generation (atypical) antipsychotics are associated with an increased risk of mortality in elderly patients when used for dementia related psychosis.
- Although there were multiple causes of death in studies, most deaths appeared to be due to cardiovascular causes (e.g. sudden cardiac death) or infection (e.g., pneumonia).
- Antipsychotics are not indicated for the treatment of dementia-related psychosis.
Suicidal Thoughts or Actions in Children, Teens, and Young Adults
Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.
- Patients treated with antidepressants may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking medications. This risk may persist until significant remission occurs.
- Patients, their families, and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient’s prescriber or health care professional.
- All patients being treated with this medication for depression should watch for and notify their health care provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.
Provided by
(November 2022)
©2022 The College of Psychiatric and Neurologic Pharmacists (CPNP) and the National Alliance on Mental Illness (NAMI). CPNP and NAMI make this document available under the Creative Commons Attribution-No Derivatives 4.0 International License. Last Updated: January 2016.
This information is being provided as a community outreach effort of the College of Psychiatric and Neurologic Pharmacists. This information is for educational and informational purposes only and is not medical advice. This information contains a summary of important points and is not an exhaustive review of information about the medication. Always seek the advice of a physician or other qualified medical professional with any questions you may have regarding medications or medical conditions. Never delay seeking professional medical advice or disregard medical professional advice as a result of any information provided herein. The College of Psychiatric and Neurologic Pharmacists disclaims any and all liability alleged as a result of the information provided herein.
Smart pills as an ethical issue - expert material, Lahta Clinic

The US Food and Drug Administration (FDA) made a decision on November 13, 2017, which immediately became the focus of attention of the world medical community and became the subject of the widest discussion. The FDA, the most authoritative organization, whose opinion is heeded all over the world, "only" approved the drug Abilify MySite for use in clinical practice. The seemingly ordinary procedure for certification of a medicinal product gave rise to heated discussions and again raised a wave of public interest in such a painful at all times, urgent and acute problem as medical ethics. nine0003
The terms “smart tablet” (mostly dietary supplements) and “smart case for tablets”, as well as several pharmaceutical trademarks registered in the post-Soviet territory using the word “smart”, have nothing to do with that “smart pill "(eng. "smart pill"), which is devoted to this review.

Let's start with the trade name "Abilify MyCite". It is very difficult to translate this game of words-neologisms into Russian: something like “Give capacity ...” or “Bring back opportunities in my case (precedent)”. Previously, the drug "Abilify Maintena" (approx. translation "Source of Opportunities Supporting") has already been approved for use, certified in the Russian Federation under the current registration number LS-001812 dated 11/16/09and sold in pharmacies under the brand name Abilify.

The drug was developed and manufactured by one of the largest Japanese pharmaceutical corporations - Otsuka Pharmaceutical Co., Ltd. In America, Abilify is distributed jointly with Bristol-Myers Squibb (New York), a company in whose name, by the way, a Russian registration certificate has been issued. However, it was Otsuka who submitted the recently approved application for certification to the FDA. This time, she is performing in a somewhat unusual collaboration for a pharmaceutical giant with Proteus Digital Health, a Silicon Valley digital technology developer. nine0003
Abilify is the trade name for aripiprazole, one of the newer atypical antipsychotics. In turn, antipsychotics are a group of antipsychotic drugs that, since the second half of the 1990s, have become one of the breakthroughs in psychopharmacology, having a number of undeniable advantages over the "traditional" or "typical" first antipsychotics - chlorpromazine and haloperidol. Like other drugs in this group, aripiprazole is used primarily in the treatment of endogenous "major psychoses" - schizophrenia, bipolar disorder and psychotic depression; clinical trials are also underway for the efficacy of aripiprazole in the treatment of alcoholism. This drug has already proven itself quite well in psychiatric practice and, according to the results of comparative studies, surpasses clozapine, olanzapine, risperidone, etc. , released a little earlier, in a number of indicators. The FDA approved the use of aripiprazole in the United States in 2002. nine0003
And today, after 15 years, Abilify with a new clarifying name is again in the spotlight. For the first time, a mass-produced dosage form containing the so-called. oral or "swallowed" tracer - a microscopic sealed radio frequency emitter that is located inside a standard capsule with the active substance. Once in the intestine, the emitter is activated and sends a signal to a miniature sensor-transmitter, which is attached, like a regular adhesive plaster, to the patient's stomach. This transmitter, in turn, transmits information about the medication to the smartphone. Thus, the patient can keep track of the time of admission and the number of doses he has already taken; in addition, he can provide the doctor and caregivers with access to this information through a dedicated web portal. nine0003
Mitchell Mathis, director of psychiatric drugs at the FDA's Center for Drug Research and Evaluation, believes that the ability to monitor prescription medications can be beneficial for some patients with mental disorders. According to M. Mathis - which, apparently, should be considered a reflection of the official position, since they are quoted in a press release - “FDA supports the development and application of new technology, therefore it intends to work with companies in studying all its benefits for patients and doctors." nine0003
So Abilify as such was certified 15 years ago; the oral sensor used in the new dosage form received FDA approval back in 2012. However, the official press release says nothing about the fact that a year and a half ago, an application for certification of a hybrid drug-and-device form was already submitted by Otsuka - and was rejected. The FDA then required companies to provide additional information about the intended use of the product and associated human risk factors, as well as to confirm that the hybrid drug can be safely and effectively used by patients. nine0003
In response, Otsuka and Proteus expressed “disappointment with the regulator’s decision,” which did not surprise commentators: a year and a half ago, a lot was written about the fact that the rejection of an application causes serious financial damage to companies, given the funds spent on the upgraded Abilify and fierce competition in the market (formerly only from authorized generic manufacturers of this drug).

Discussions today are dominated by restrained joy at the advancement of new technologies, but there is also some bewilderment. So, commentator Rebecca Robbins notes: forgetfulness and twilight consciousness can accompany those mental disorders for which Abilify is approved for treatment, and patients have to make a lot of effort to take the required medications on time. However, the new drug will come with a warning on the packaging: "Technology has not been proven to help patients take their medications as prescribed." nine0003
Immediately following the FDA decision, the journal Anesthesia & Analgesia published the results of a mini-study conducted in Boston on a sample of 15 patients who had suffered fractures and were prescribed opioid analgesics. The study used smart tablets similar to Abilify. The paper's lead author, Dr. Edward Boyer, says the new technology is highly promising, saying it provides a "direct measure" of how many opioids are being taken, which in some cases could be a warning sign of developing tolerance or dependence. nine0003
Professor of Psychiatry Tia P. Powell (Albert Einstein College of Medicine, New York) looks at the news from a completely different perspective.

“Unfortunately,” Dr. Powell's article begins, “unfortunately, the first FDA-approved smart pill was a drug used in the treatment of schizophrenia and bipolar disorder. This again raises confusing ethical questions."

Clinical experience and decades of research, it goes on to say, confirm that off-label drug use is a major problem in all branches of medicine. Smart pills can help forgetful people with diabetes, heart problems, and other drug-dependent patients who would like to achieve more and feel better with a prescribed treatment regimen. There is no doubt that, says Prof. Powell that mental illness drastically reduces the quality of life and its duration, and in this regard, drugs can really be useful. It is the WHO who defines mental disorders as the “major contributor” to the global damage from diseases in general. Psychotic episodes are typical of patients who are not taking psychiatrist-prescribed drugs, and such episodes not only further damage the brain, but often endanger both the patients themselves and others. Compliance with prescriptions for patients with mental illness is just as important as for somatic patients. What makes the high-tech version of aripiprazole problematic, however, is that this hybrid drug can easily be used in coercive treatment that ignores the values and preferences of the mentally ill themselves. In general, forced therapy is a long and painful problem in the history of psychiatry. In certain situations, a person with a mental disorder may be subjected, regardless of consent or disagreement, to inpatient or outpatient treatment, sometimes with compulsory medication. Of course, the best medicine in the world won't help, notes Tia P. Powell, if you don't take it. But only at 19In 1970, the US Supreme Court for the first time recognized a legal deficit in people hospitalized against their will. Both clinicians and patients around the world struggle to strike the right balance between safety and individual rights.

A new dosage form is at the very center of this struggle. Manufacturers assure us that patients will consent to such treatment and the use of tracking technology. However, this smart tablet is very attractive for judicial applications. For those patients who are ordered to take drugs by the court, "consent" takes on a very different meaning if it is exchanged for freedom, custody of a child, or a reduced sentence. nine0003
I'll bet, says T. P. Powell, that people will look for ways to outsmart the tracker, while the manufacturers of this expensive drug have gone to great lengths to make it harder to disable the tracker. But I'd rather see an innovation that would serve to build trust and collaboration between doctor and patient.

We need to take a closer look not only at the benefits of Abilify MySite's hybrid drug, the article says, but also at the risks associated with it. It will help some people take their medication as prescribed, but it can also be a high-tech form of psychiatric coercion. If the new drug improves the treatment of "major psychoses", then it is necessary to carefully consider who, in fact, will benefit and who may suffer. nine0003
Abilify MySite has been approved without any indication of its ethical use. “I am convinced,” Professor Powell concludes, “that both clinicians and consumers should be involved in the development of such ethical guidelines. True progress in psychiatry involves a genuine respect for those who struggle with mental illness, and not just the development of new ways to apply treatment to these people.

The publication evoked heated and sometimes diametrically opposed comments from specialists, patients, their relatives and people who are simply not indifferent to the problem. nine0003
Robert P.N. Shirin: “Professor Powell seems to be inclined to think of the new drug as something like a Trojan horse in the mouth. I wonder if she sees an ethical problem in DOT (the so-called "Treatment under direct supervision" - approx. Lakhta Clinic), which is a common practice in the fight against tuberculosis?

Steven J. Leitner: "The article ignores the fact that, say, long-acting drugs have been around in psychiatry for decades and perform essentially the same function." nine0003
Marie Lutz: “There is absolutely no evidence that psychotic episodes “destroy the brain”… Another question, and it is not raised in the article, is who and how will justify compulsory treatment with an antipsychotic that has such extensive and serious side effects. effects such as weight gain, tardive dyskinesia, akathisia and reduced life expectancy. In addition, it is doubtful that if atypical antipsychotics can help some people (usually for a short time), then they should necessarily be taken by all other patients. Personally, I believe that the new drug is a "bad faith development" and should be recalled. nine0003
Karen D'Angelo: “While I wholeheartedly support a patient's right to choose, as a neighbor of a schizophrenic patient, I also see the consequences of patients not taking their prescribed medications when the judicial system is overly concerned with ensuring compliance (compliance is therapeutic union of a doctor and a patient - approx. Lakhta Clinic).

Chris Lowland: “Non-stop medication does more harm than good. Only dotted, intermittent treatment can be optimally effective. (It is known that the main difficulty is to interrupt the development of the disease). nine0003
Jason R. West: “You either don't need or don't like the drugs. How many people have you seen who are voluntarily treated, but at the same time they accidentally take medicines incorrectly?!”…

All brand names and trademarks mentioned in the text belong to their registered copyright holders.

Based on Stat News, FDA, MedLine plus, Fierce Pharma

Rispolept (risperidone) for autism: what do parents need to know?

However, Rispolept can cause serious side effects and it is very important to closely monitor the health of the child taking it. Parents should be aware that the doctor who prescribes Rispolept should carefully monitor the child's condition to ensure that he receives the best possible treatment.

Below is some basic information about Rispolept: why you need it, what are the potential side effects, and how to monitor your child while taking Rispolept.

Action of Rispolept

Rispolept belongs to new generation neuroleptics or atypical antipsychotics. This is a class of antipsychotics that was approved in the 1990s for the treatment of psychotic symptoms in schizophrenia and bipolar affective disorder.

It is now more commonly used to reduce aggressiveness and irritability in patients with dementia and in children.

In children with autism, Rispolept may be prescribed to reduce behavioral problems such as aggression and self-harm, and has been approved for this very purpose. It may also be given to children with other disorders, such as attention deficit hyperactivity disorder (ADHD). nine0003
Generally, Rispolept and other atypical antipsychotics are needed only if the children's behavior is dangerous to themselves or others, or there is a risk of being excluded from the classroom or hospitalized for behavioral problems. In this case, Rispolept is used to make the child calmer. The use of the drug for this purpose has only been approved for children with autism, but a large body of research suggests that it is effective in reducing persistent behavioral problems in various disorders. nine0003
Why is the use of Rispolept considered controversial?

Rispolept is considered controversial because its side effects can include significant weight gain, as well as metabolic, neurological and hormonal changes in the body.

Some experts are concerned that children may be put on the drug right away instead of alternative treatments, primarily behavioral therapy, that can solve the same problem without the risk of side effects. nine0003
Over the past few years, the media has covered many lawsuits from parents who claim they were not informed about how the side effects of risperidone could affect their children and that their children were not stopped when problems developed. The lawsuits included cases of boys who developed breasts due to elevated levels of the hormone prolactin, one of the rare side effects of risperidone.

Problems at school and at home

Dr. Wendy Moyal, child and adolescent psychiatrist at the Child Mind Institute (an American non-profit organization that specializes in children's mental health), describes a typical scenario for prescribing Rispolept because of aggressiveness or irritability, leading to severe behavioral problems. Very often, these problem behaviors begin in early adolescence, says Dr. Moyal: "We're talking about extremely aggressive kids who push, shoved, punched, broke furniture." nine0003
If such children cannot control their emotions at all, they can be dangerous to other children, their own parents, and themselves. “Their parents may be so desperate they call 911,” says Dr. Moyal. Or the child has already been hospitalized by ambulance after a behavioral explosion at school.

Many experts believe that during a crisis like this, the doctor's best bet is to start treatment with risperidone to stabilize the situation.

However, outside of a crisis, experts recommend trying other approaches to correct problem behavior first. nine0003
Behavioral Therapy

Most experts, including Dr. Moyal, emphasize that the possible causes of aggressive behavior must be carefully considered when deciding whether to prescribe a drug. Behavioral problems can have many different causes, including undiagnosed anxiety disorder, ADHD, learning disabilities, psychological trauma, and medical problems. Treating these problems may be more effective at reducing unwanted behavior than antipsychotics. nine0003
If the child's behavior has not yet reached the crisis stage, experts recommend that as the first therapy, correction based on applied behavior analysis, including teaching parents how to properly respond to problem behavior and engage in its prevention.

Dr. Moyal says she herself usually recommends a behavioral therapy first or a drug at the same time as the behavioral therapy, depending on the level of risk.

Alternative drugs

In relatively stable situations, Dr. Moyal also prefers drugs that are more precise than Rispolept and have fewer side effects. For example, if a child has ADHD, stimulants (Ritalin or Adderall) or non-stimulant ADHD medications, such as clonidine or guanfacine, can reduce impulsive aggression. If a child has an obsessive-compulsive disorder, antidepressants (SSRIs) can reduce the depression or anxiety that triggers behavioral outbursts. nine0003
Dr. Moyal may try an atypical antipsychotic if other approaches fail. The neuroleptic aripiprazole (Abilify), which is often used for aggression, has also been approved for the treatment of irritability in children on the autism spectrum. Dr. Moyal often chooses it because it has fewer side effects than risperidone, including less weight gain and less endocrine disruption.

However, Dr. Moyal emphasizes that medication for autism should always be accompanied by behavioral therapy that includes parental education. nine0066 The medical community as a whole agrees. The survey, which was conducted among leading experts in the field of autism treatment, showed that each of them believes that drugs should not become a substitute for behavioral therapy.

The experts also note that if a child in crisis has been prescribed an atypical antipsychotic, then after stabilization, you can try to transfer him to another treatment. In Dr. Moyal's experience, children who receive behavioral therapy may find it easier to stop taking the drug later on. nine0003
“I prefer to use risperidone for a limited period of time until the crisis is over,” she explains. “And at the same time I organize behavioral therapy with parent education.”

Dr. Michael Milgham, child and adolescent psychiatrist at the Child Mind Institute, also uses the new generation of atypical antipsychotics to stabilize children in crisis situations.

However, he emphasizes that it can be dangerous to stop a child's medication until they have another support system, such as behavioral therapy. nine0003
“It's very important to know when to try to stop a child's drug—not to do it as soon as things get better,” explains Dr. Milgham. - The child's condition must be stable and he must receive regular support through other methods. Otherwise, you will only create more problems, and the child will end up in the emergency room.”

Side effects of Rispolept

Weight gain

The most common side effect of Rispolept is weight gain, which can occur very quickly. In one study, the mean weight gain after 10.8 weeks of risperidone was 4.9kg compared to only 0.2 kg among children who took placebo. In a study of children who took risperidone for 2.9 years, one in three children were overweight or obese. The higher the dose of the drug, the greater was the weight gain associated with it.

Metabolic side effects

Rispolept can also cause so-called "metabolic abnormalities", including increased levels of sugar, lipids and triglycerides in the blood, which increases the risk of diabetes and heart disease later in life. These disorders are more common in children who are overweight or obese. nine0003
The atypical neuroleptics with the greatest risk of metabolic disorders are olanzapine (Zyprexa) and clozapine (Clozaril). Seroquel (Quetiapine) and Rispolept are somewhere in between. The lowest risk of such side effects exists for aripiprazole, ziprasidone and lurasidone.

Neurological side effects

Other possible side effects include a condition called tardive dyskinesia. This dyskinesia is characterized by involuntary, repetitive movements, such as facial grimaces. The risk of tardive dyskinesia increases with higher dosage and prolonged treatment, and this condition may be permanent. The greatest risk of neurological side effects is associated with Rispolept, Zyprexa and Abilify. nine0003
Hormonal side effects

A side effect that has led to lawsuits against Johnson & Johnson, the manufacturer of Risperdal (one of the trade names for risperidone), is an increase in a hormone called prolactin. Elevated prolactin levels are called hyperprolactinemia. Normally, prolactin causes breast enlargement during pregnancy and breast milk production, as well as loss of bone strength. In boys, this hormone can interfere with the formation of sperm and cause breast enlargement, the so-called gynecomastia. nine0003
Studies show that when children take antipsychotics, prolactin levels rise during the first 6-8 weeks (in one study it was four times higher than among children taking placebo), but then it returns to normal. It seems that high doses of risperidone, but not its long-term use, are associated with elevated prolactin levels.

However, not all children with elevated prolactin levels develop unwanted symptoms. Hyperprolactinemia is common (in 1-10% of patients), but associated symptoms such as gynecomastia are rare (in 0.1-1% of patients). nine0003
Among the new generation antipsychotics, Rispolept is associated with the greatest increase in prolactin levels, and Abilify with the least.

Tracking side effects

Children taking Rispolept or other atypical antipsychotics should be regularly checked by a doctor during treatment. Before starting the drug, you need to establish their initial height, weight, general health, levels of prolactin, fat and blood sugar.

During the first few months of treatment with Rispolept or another atypical antipsychotic, prolactin levels should be measured frequently. With an increased level of prolactin and the appearance of symptoms of hyperprolactinemia, it is recommended to reduce the dose and transfer the child to another drug. If the child does not have symptoms of elevated prolactin levels, it is recommended that the child be examined annually if the child is planned to take the drug for an extended period, since the possible effect of prolonged elevated prolactin on fertility and bone development is unknown. nine0003
A team of Canadian researchers previously noted that blood tests and a physical examination of a patient in stable condition can be seen as a waste of time by busy doctors. However, given the possible negative consequences, they believe: "If the doctor is not ready to regularly examine the child for side effects, then he should not prescribe these drugs."

Working with your doctor

As with any drug, it is very important that you discuss any concerns with your doctor. Your doctor should be prepared to discuss with you the symptoms you are experiencing and explain your options for changing the dosage or changing the drug. If you feel that your child's doctor is not taking your concerns seriously, or that the doctor is not following drug selection and dosage recommendations, or that he is adding new drugs to those already taken, you should seek the opinion of another specialist. nine0003
If you think that your child should stop taking Rispolept, be sure to tell the doctor about it, discuss the pros and cons. Do not change the dose of the drug or stop taking it without consulting your doctor. Antipsychotics should not be discontinued immediately but should be tapered off very gradually and the child should be monitored for withdrawal symptoms such as runny nose, diarrhea and abdominal pain. And remember, the main symptom to look out for is the return of the dangerous behavior for which the drug was prescribed. nine0003
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Action of Rispolept

Why is the use of Rispolept considered controversial?

Problems at school and at home

Behavioral Therapy

Alternative drugs

Side effects of Rispolept

Weight gain

Metabolic side effects

Neurological side effects

Hormonal side effects

Tracking side effects

Working with your doctor

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