Abilify (generic name aripiprazole) is an antipsychotic drug first approved for use in the United States in 2002 to treat schizophrenia, but its uses have grown and many doctors also prescribe it for off-label uses. It works by affecting chemicals in the brain (dopamine and serotonin) to keep them in balance.
But the drug is associated with many side effects, some of them serious. The Food and Drug Administration (FDA) even requires boxed warnings of increased risk of mortality for elderly patients with dementia, as well as a risk of suicidal thoughts and behaviors among children and young people. Some patients taking Abilify also report compulsive urges to gamble, leading some to financial hardship and ruin.
Abilify is manufactured by Otsuka Pharmaceutical Co., which markets the drug with Bristol-Myers Squibb in the United States. It has several listed and approved uses:
- Add-on for adults with depression already taking an antidepressant.
- Bipolar I disorder for manic or mixed episodes
- Children with autistic disorder who suffer from irritability
- Agitation related to schizophrenia or bipolar I disorder
- Children with Tourette’s disorder
But doctors are free to prescribe Abilify for off-label uses as well, and many do. Doctors may use the drug to treat patients with anxiety and obsessive-compulsive disorder (OCD), for example.
Abilify is available as a tablet, disintegrating tablet, oral liquid, and injectable liquid. Doctors may prescribe the injection form of the drug to treat agitation associated with schizophrenia or bipolar I disorder.
Complications Associated with Abilify
Abilify is associated with several troubling complications and even includes a couple boxed warnings – the most significant warning required by the FDA.
Abilify Interactions and Warnings
Some medications may interact with Abilify, and doctors should evaluate other medications, supplements, and vitamins patients are taking to prevent adverse reactions. Some patients may need to stop taking or reduce their dosage of other medications when taking Abilify.
The FDA classifies Abilify as a Category C drug for pregnant women. It may cause complications for the fetus, and doctors should evaluate the risk to the fetus versus the benefits of the drug to the mother. Similarly, doctors should evaluate how the drug benefits the mother compared to the potential risk to the nursing infant.
Abilify, Gambling and Other Compulsive Disorders
Many patients have reported unusual increases in compulsive behavior such as gambling. They may find it impossible to stop gambling and placing bets, causing some patients taking Abilify to lose large sums of money or accumulate significant debt. Some patients report that after they stopped taking Abilify, their urge to gamble ceased.
Other unusual urges or behaviors include increased sexual desires, excessive or impulsive shopping, and binge eating.
In August 2016, Abilify added a warning of pathological gambling and other compulsive behavior. But for some patients, this came too late. Lawsuits filed against Otsuka Pharmaceutical Co. and Bristol-Myers Squibb claim that they did not warn doctors and patients taking the drug of this adverse reaction.
Boxed Warning: Abilify and Risk of Death for Dementia Patients
Studies have found a link between Abilify use in older adults with dementia and increased risk of death. The drug may increase the risk of stroke, mini-stroke, or other severe side effects in these patients.
The FDA has not approved Abilify for use in adults with mental illnesses whose doctors have also diagnosed them with dementia. Family members should talk to a doctor if their loved one is taking Abilify and a doctor diagnosed them with dementia.
Boxed Warning: Abilify and Suicide
The FDA has received reports of children, teenagers, and young adults with depression who developed suicidal thoughts or tendencies after treatment with antidepressants. Patients taking Abilify may be more likely to consider suicide than patients who did not take antidepressants to treat their mental illness.
Patients of any age may experience unexpected mental health changes when they start taking Abilify. The following could be signs of increased risk of suicide:
- New or worsening depression
- Planning, thinking about, or attempting self-harm or suicide
- Extreme worry
- Unprovoked agitation
- Panic attacks
- Difficulty sleeping or staying asleep
- Aggressive behavior
- Severe restlessness
- Abnormal excitement or frenzy
Other Abilify Side Effects
Abilify has several other listed side effects of which the manufacturer must warn patients, ranging from mild to severe. The mild side effects associated with the drug may include:
|· Constipation||· Diarrhea||· Dizziness|
|· Drowsiness||· Headache||· Heartburn|
|· Increased appetite||· Increased salivation||· Nervousness|
|· Pain in arms, legs, joints||· Stomach pain||· Weight gain|
Patients should monitor these symptoms and talk to their doctor if they persist or become severe. Severe side effects may include:
|· Vision changes||· Chest pain||· Confusion||· Sweating|
|· High fever||· Hives||· Itching||· Muscle stiffness|
|· Rash||· Seizures||· Swelling||· Throat tightness|
|· Trouble breathing or swallowing||· Tightening of the neck muscles||· Fast, slow, or irregular heartbeat||· Uncontrollable movements|
Many of these side effects can be life-threatening, and patients should contact their doctor immediately if any of these symptoms develop.
Abilify has been the subject of several lawsuits by patients harmed by the drug. You might have a legal case if you or a loved one experienced any of the following adverse reactions while taking Abilify:
- Sudden death
- Stroke or mini-stroke
- Damages related to compulsive gambling
- Severe complications from side-effects
These conditions can cause severe damages to a patient’s health, finances, and quality of life. Lawsuits against the manufacturer, Otsuka Pharmaceutical Co., or Bristol-Myers Squibb, which helped market the drug, allege improper warning and other negligence.
Your doctor or the pharmaceutical company might be liable for your damages. Compensable damages may include medical costs and other financial losses, pain and suffering, and more. For more information about filing a lawsuit if you were harmed by Abilify or for help finding a lawyer in your area, call 1-800-DRUG-411.