Drug
Abilify
Abilify, a widely prescribed treatment for depression, schizophrenia, autism and bipolar disorder, quickly became a best-selling drug in the United States. Though the antipsychotic is used by millions of Americans each year, Abilify side effects can be severe.
2002
Depression, schizophrenia, autism and bipolar disorder
Behavioral changes and thoughts of suicide
The Truth
Abilify, also known as aripiprazole, is a second-generation antipsychotic prescribed to patients with various mental illnesses. As an atypical antipsychotic drug, Abilify is added to a treatment plan when antidepressants do not suffice. It is also given to people diagnosed with bipolar I, schizophrenia, or autism-related irritabilities.
A joint venture between Bristol-Myers Squibb and the Otsuka Pharmaceutical Company, Abilify is one of the most prescribed drugs in the United States. In 2015, Abilify was the country’s second best-selling drug, netting $7.2 billion. Thanks to extensive television advertising, it’s become a household name.
Despite its popularity, Abilify has been linked to behavioral changes and thoughts of suicide, among other serious side effects. It can be particularly dangerous for young adults and elderly people with dementia.
Millions of Americans suffer from depression. According to the commercials, Abilify is not for everyone.
Abilify’s Uses
The manufacturer’s website lists four main conditions, including:
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DEPRESSION |
Used as an add-on for adults with depression when an antidepressant alone is not enough |
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MANIC EPISODES |
Treatment of manic or mixed episodes associated with bipolar I disorder in adults and pediatric patients 10 to 17 years old |
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SCHIZOPHRENIA |
Treatment of schizophrenia in adults and adolescents 13 to 17 years of age |
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AUTISM |
Treatment of irritability associated with autistic disorder in pediatric patients 6 to 17 years of age |
Studies + Science
How Abilify Works
Mental illness is believed to be caused by a disturbance in the brain’s messaging system. Abilify works to reduce feelings of depression through interactions with multiple neurotransmitters, which send messages throughout the brain.
Abilify differs from first generation drugs of its kind. The first generation drugs work only on dopamine receptors, whereas Abilify targets dopamine and serotonin. Known as a second-generation antipsychotic (SGAs), Abilify is an enhancer, prescribed alongside other antidepressant medications.
Abilify, available in doses of 2 mg to 30 mg, alters brain chemicals to stabilize them instead of acting as a blocking agent. Tardive dyskinesia, a movement disorder, is a side effect of antipsychotics. It’s less common when taking Abilify.
Abilify Side Effects
Certain side effects will affect between 1 and 10 out of every 100 people, including:
- Abnormal movements of the hands, legs, face, neck and tongue
- Feeling restless, agitated and unable to sit still
- Anxiety
- Dizziness
- Difficulty sleeping
- Sleepiness
- Sedation
- Headache
- Blurred vision
- Gut disturbances such as constipation, indigestion, nausea and vomiting
- Increased salivation
- Fatigue
Rare Abilify side effects, many of which are linked to the loss of prolactin, may occur, including:
- Rash
- Increased appetite
- Dry mouth
- Muscle aches
- Seizure
- Agitation
- Females losing their period and/or production of breast milk
- Males losing their sex drive or possibly experiencing erectile problems
- Osteoporosis or increased risk of bone fractures
- Extrapyramidal effects and tardive dyskinesia
- Metabolic syndrome
Age-Related Abilify Side Effects
Studies show that Abilify affects adolescents and elderly populations differently. Data illustrates that Abilify can increase the risk of suicide in young adults.
Abilify is particularly dangerous for the elderly. The drug can increase the risk of heart attack, stroke and infection in older patients. Analysts evaluated 17 trials, which included 5,106 elderly patients with dementia-related behavioral disorders. Though minimal, the results showed a potentially increased risk of death.
Compulsive Behaviors
Abilify and other atypical antipsychotics have been linked to the inability to control certain behaviors. People using Abilify might be unable to leave a blackjack table, put down a pizza, or say no to sex.
The behaviors may become compulsive and pathological. While the cause is not entirely clear, some researchers believe compulsive behaviors are linked to dopamine.
A paper published in the British Journal of Psychology examines three case reports that tie pathological gambling to Abilify’s treatment of psychosis. The paper notes “distinct changes in their approach to gambling following the initiation of aripiprazole,” including:
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Case Study 1 |
J was referred to the clinic aged 29 and was taking aripiprazole 5 mg for the treatment of paranoid schizophrenia. He reported a 12-year history of regular gambling and was gambling daily at the time of assessment. In his first treatment session, `he described feeling that the medication had caused an escalation in his gambling and ceased taking it. J managed to stay abstinent from gambling for the next four weeks, with the exception of one lapse. Two weeks later he was placed back on aripiprazole 15 mg following a relapse of psychotic symptoms and subsequently reported the return of strong urges to gamble that he found difficult to resist. He was pre-occupied with thoughts of gambling, and his gambling activity became both impulsive and involved extensive planning in obtaining funds to gamble, including the use of crime. Following discussions with his psychiatrist, J was changed to quetiapine 400 mg and later to sulpiride 600 mg. He subsequently reported a qualitative change in his gambling, with an absence of ongoing thoughts and plans to gamble. This abstinence had been maintained when J was followed up 6 months later. |
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Case Study 2 |
K referred himself to the clinic aged 28 and had previously been diagnosed with schizoaffective disorder. At assessment, K described a history of gambling on fruit machines as a teenager, and fixed odds betting terminals in his twenties. He would usually gamble two or three times a week, spending about half of his money, but reported a change in his gambling following a hospital admission 10 months earlier. During the admission his medication was changed from risperidone to aripiprazole 15 mg. On leaving hospital, approximately 3 months after the prescription of aripiprazole, K described an escalation in his gambling to the extent of spending all of his money and it being ‘a reason to live’. By the time he presented to the clinic he had limited his access to money but described spending 8 hours a day searching the internet for free gambling opportunities. Following a recommendation to his psychiatrist, his medication was changed to quetiapine. K reported this having a ‘massive impact’ on his gambling. After three months of treatment, he felt no preoccupation or compulsion to gamble, and was playing only once per week. |
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Case Study 3 |
S self-referred to the clinic aged 26 and was taking aripiprazole 15 mg for the treatment of schizophrenia. S had experienced one episode of psychosis in 2002 and had previously taken risperidone. S reported no history of gambling prior to starting aripiprazole in summer 2006. In summer 2007, he began experiencing strong urges to gamble in the form of a euphoric feeling when thinking about gambling. In the following two years he incurred debts of around £25 000 on internet betting sites. S was the third individual taking aripiprazole seen since the opening of the clinic. As a consequence of the previous cases, the team wrote to his psychiatrist in the community, suggesting a review of medication. Given the time since his original psychotic episode, the decision was taken to cease all medication. S attended 1 month after discontinuing aripiprazole and reported no thoughts or ‘drive’ to gamble. He described an inability to reflect on his behavior when taking aripiprazole and always suspected it had induced his gambling. S completed a gambling craving scale previously adapted from the Penn Alcohol Craving Scale. His score of 13/ 30 at treatment start had reduced to 5/30 by treatment end, indicating ‘rare’, ‘slight’ urges that were ‘mildly’ difficult to cope with. His abstinence from gambling had been maintained at both 3 and 6-month follow-ups. |
Impulse control is our brain’s way of protecting us. Without it, it’s possible to fall into serious debt or develop dangerous health problems. Studies show that these uncontrollable urges stopped when patients no longer took the medication.
Regulation Recap
The FDA approved Abilify in 2002 as an add-on treatment for depression. Later, the agency expanded its uses, making it available to a wide variety of psychiatric patients. Abilify was prescribed to 1.6 million patients in 2015.
Black Box Warning
The FDA included a black box warning, its most serious alarm, to Abilify’s labeling. Abilify can be particularly dangerous for people under the age of 18 and elderly patients.
According to the National Alliance on Mental Illness, the warning deals with:
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Increased Mortality in Elderly Patients with Dementia Related Psychosis |
Depression, Suicidal Thoughts or Actions in Children and Adults |
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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. |
Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression, 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. |
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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). |
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 healthcare professional. |
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Antipsychotics are not indicated for the treatment of dementia-related psychosis. |
All patients being treated with this medication for depression should watch for and notify their healthcare provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment. |
2016 Safety Communication
In an FDA safety alert, issued in May 2016, the regulatory agency acknowledged that the impulse control problems linked to Abilify may be more serious. The announcement focuses on compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex.
The announcement comes after an analysis of the adverse events reported to the FDA Adverse Event Reporting System (FAERS) database. A total of 184 cases illustrated impulse-control problems linked to Abilify. In the U.S., there were 167 U.S. cases that included both adults and children. Pathological gambling was the most common.
“These impulse-control problems are rare,” the FDA wrote, “but they may result in harm to the patient and others if not recognized.”
2017 Pediatric Postmarketing Pharmacovigilance and Drug Utilization Review
A 2017 meta-analysis of Aripiprazole conducted by the Department of Health and Human Services Public Health Service, FDA Center for Drug Evaluation and Research, and Office of Surveillance and Epidemiology found 13,544 adverse event reports related to Aripiprazole from May 1, 2011, to Nov. 30, 2016. Of those cases, the FDA labeled 7,660 as serious cases with an additional 808 deaths. Of those deaths, most of the under 18 deaths were either from medications not cooperating, or intentionally suicidal behavior.
In their analysis, the FDA stated that “none of the causes of death were attributed solely to aripiprazole. Five of the deaths were related to suicidal behavior, only one of which provided sufficient information to determine a possible causal relationship between aripiprazole and suicidal behavior; however, this case is confounded by the patient’s underlying depression.” In addition to the deaths, the FDA determined that “Over half of the 64 non-fatal cases (n=35) reported drug ineffective.”
In conclusion, the FDA stated that “[t]here were no clear patterns of reported adverse events in the FAERS cases or trends in drug utilization to suggest a new safety signal associated with oral formulations of aripiprazole in pediatric patients at this time.” The coalition announced its intent would be to continue to monitor the medication in case a trend did emerge.
The Next Steps
Abilify can save lives, but in some cases, introducing it to psychiatric treatment might make matters worse. Abilify can worsen depression and spark a chain of compulsive, pathological behaviors.
Bristol-Myers Squibb, the makers of Abilify, paid $19 million in an illegal marketing settlement. Abilify may be one of Big Pharma’s main moneymakers, but that doesn’t mean each patient shouldn’t matter. Patients already struggling with mental illness could have been put in serious danger.
Help is out there. Connect with an advocate to learn more.
Contact UsAbilify has been linked to suicidal thoughts, compulsive behaviors, and problems with impulse control.
Abilify can lead to increased suicidal ideation and erratic impulse control.
The FDA added a Black Box Warning to Abilify’s labeling, which is the highest level of consumer caution.
Abilify can affect the mind, but there are options to help you move forward.