The Abilify injury attorneys at the Drug Law Center are currently investigating cases involving injuries caused by the antipsychotic medication initially approved as safe by the FDA.
Abilify (aripiprazole) is a prescription antipsychotic medication approved by the Food and Drug Administration (FDA) to treat mood/mental disorders including schizophrenia, Tourette syndrome, depression, and bipolar disorder. Some doctors prescribe the medication to treat autism-associated irritability. It has not been determined that the drug is effective or safe used by children younger than 13 years old suffering with schizophrenia or 10 years or younger suffering with bipolar disorder. Any use of Abilify to treat dementia-related psychotic conditions is considered “off-label” use that has not been approved by the FDA. Many young patients prescribed Abilify have experienced suicidal ideation (the thought of suicide) when the drug is taken for psychiatric disorders and major depressive disorder. Many adolescents and adults taking Abilify tend to experience compulsive behaviors including compulsive gambling, hypersexuality, and obsessive eating.
The History of Abilify
Aripiprazole was initially discovered in 1998 and approved by the Food and Drug Administration (FDA) for use in the United States in November 2002 for the treatment of schizophrenia. By 2004, the FDA approved the drug to treat bipolar disorder and in 2007 approved the medication to assist in the treatment of major depressive disorder. By 2009, the FDA approved the antipsychotic drug to treat autistic children’s irritability.
Since its introduction into the medical marketplace, Abilify (aripiprazole) has been offered in different dosage forms to be taken as intramuscular injections, oral solutions, and in tablet form. In 2013, Abilify generated $7 billion in revenue selling Abilify worldwide.
How Abilify Works
Abilify is a second-generation antipsychotic (SGA) that were significantly different than Haldol and Thorazine which are first-generation antipsychotics that likely only target the brain’s dopamine receptors. SGAs are known to target serotonin and dopamine and tend to reduce fewer side effects involving movement including involuntary movement disorder (tardive dyskinesia).
Both the brand-name (Abilify) and the generic form aripiprazole work differently than most second-generation antipsychotics in that they enhance serotonin and dopamine levels or inhibit their production to maintain a balance. Often referred to as a serotonin-dopamine system stabilizer, the medication is often prescribed alone and concomitantly with other drugs to maximize their efficacy.
Even though the FDA has limited its approval of the uses of Abilify and aripiprazole, doctors continue to prescribe the drug for “off-label” uses that include anxiety spectrum disorders, delusional disorders, and insomnia.
Aripiprazole Side Effects
Like most prescription medications, Abilify (aripiprazole) have frequent side effects that are not necessarily severe. These include sedation, lethargy, drowsiness, dizziness, salivation, and urinary incontinence. However, there are also unwanted serious side effects that often occur and might require the patient to seek out immediate medical attention. These major side effects that occur when taking aripiprazole (Abilify) include:
- Difficulty with speech
- Inability to control balance
- Limit Stiffness
- Jerking or trembling muscles
- Twisting movement
- Shuffled walking
- Uncontrollable face, neck and back movements
- Blurry vision
- Fast or Slow Heart Rate
- Unusual facial expressions
- Difficulty in swallowing her breathing
- Increasing eyelid spasms or blinking
- Convulsions, high fever, or pale skin
- Puffiness, itching, swelling of the tongue, lips, face, eyes or eyelids
- Welds or hives
- Skin rash and skin itching
- Chest tightness
- Skin redness
- Unexpected weakness or tiredness
The list of the above major side effects is not complete. Many patients suffer minor side effects that might not require immediate medical attention. However, most minor effects are bothersome. The most common minor side effects from taking Abilify include:
- Weight gain
- difficult bowel movements
- Dry mouth
- Sensation of fear
- Sore throat, runny nose, and sour or acid stomach
- Skin rash
- Muscle cramping or aching
- Joint pain
- Increased appetite
Black Box Warning
The FDA requires that all prescription medications have comprehensive black box warnings that detail specific serious hazards that are likely or potentially likely to cause serious adverse reactions, side effects or even death.
The Black Box Warning on bottles of Abilify (aripiprazole) warns of the potential risk to increase suicidal ideation in children, young adults, and adolescents, especially those who are taking the medication to treat psychiatric disorders and depression. The warning also states there is an increased mortality rate in elderly individuals suffering dementia-related psychosis who take Abilify.
FDA Warns of Abilify-Related Compulsive Behavior
Even though Abilify is recognized from the most optimal medications sold in the United States, it has also been blamed for producing compulsive behaviors including excessive gambling, overeating, binge shopping and obsessive sex. Researchers believe that the antipsychotic medication is effective because it stimulates dopamine receptors in the brain that tend to increase the body’s craving for pleasure. Unfortunately, the compulsive behavior risks associated with taking Abilify can produce life-altering consequences for family members that include:
- Irreparable damage to the individual’s reputation
- Emotional trauma
- Home and business foreclosure
In 2016, the Food and Drug Administration released a safety announcement that warned Abilify users “the compulsive or uncontrollable urges to gamble, binge eating, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced.”
In the previous year (2015), the FDA revealed statistics showing that 1.6 million Americans had been prescribed aripiprazole medications including Abilify. In recent years, thousands of lawsuits have been filed and consolidated in MDL (multidistrict litigation) cases filed in the Northern District of Florida.
Over-dosage and Contraindications
Patients taking Abilify reported accidental and deliberate overdosage during clinical trials and after the drug became available in the medical marketplace. Worldwide reports of overdoses involve taking the medication alone and/or concomitantly with other substances. Fortunately, there have been no reported fatalities by taking the drug alone.
In at least five percent of all cases involving overdoses, the patient suffered mild to severe side effects including tremors, somnolence (sleeplessness), vomiting, acidosis, atrial fibrillation, convulsion, confused state, coma, bradycardia (slow heart rate), hypertension, hypotension, hypokalemia, pneumonia aspiration, loss of consciousness, tachycardia, respiratory arrest and others.
Patients with a history of hypersensitivity reaction to Abilify (aripiprazole) have suffered mild to severe contraindication reactions ranging from anaphylaxis to itching (pruritus) and hives (urticaria). Known severe interactions when using Abilify with other substances have led to serious consequences when the antipsychotic medication is used concomitantly with Exelon (rivastigmine), Meridia (sibutramine), Reglan (metoclopramide).
Before Taking Abilify
While some of the side effects and adverse reactions caused by Abilify are mild, others can be life altering and permanent. Because of that, it is essential to discuss any allergic reactions you had with aripiprazole or other drugs with your doctor. It is essential to review the list of ingredients used to make the drug. In addition, you should make a list for your doctor of all prescription and nonprescription drugs, natural supplements, vitamins and herbal products you are currently on or will be on while taking Abilify. This includes:
- antifungal medications
- anxiety medications
- irritable bowel syndrome drugs
- medications to treat high blood pressure
- motion sickness
- mental illness
- urinary problems and others.
It is essential for your physician to understand if you are currently taking illegal medications or have done so previously. In addition, the doctor should know if you have ever suffered from heart failure, heart disease, irregular heartbeat, heart attacks, a stroke, seizures, lower high blood pressure, low white blood cell counts or any condition that causes the difficulty in swallowing.
If aripiprazole (Abilify) is being prescribed to treat a child’s condition, the treatment should also involve special education and counseling where the drug is given in accordance with the therapist or doctor’s instructions. Elderly individual suffering with dementia should never take atypical psychotic medications because the FDA has issued a warning claiming there is an increased potential of death when taking the drug.
Every patient taking the medication should be appropriately monitored and closely observed to look for any unusual or sudden changes in their behavior including suicidal ideation thoughts or worsening clinical conditions.
No known settlements involving Abilify or the drugs generic form aripiprazole have been publicly reported. However, many lawsuits have been filed against Bristol-Myers Squibb and Otsuka pharmaceutical, makers of the medication. However, there was a settlement in 2007 between the US Justice Department and Bristol-Myers Squibb for $515 million that was distributed to over 40 states. The settlement was reached over a claim that medical professionals were illegally paid by Bristol-Myers Squibb in their effort to promote Abilify prescriptions for off-label uses.
Many Abilify lawsuits filed nationwide were consolidated in federal court in the Northern District of Florida to be heard as a multidistrict litigation case. This means all the federal cases will be heard in front of a single judge to help unify evidence and streamline the cases. Many plaintiffs are alleging that Bristol-Myers Squibb and Otsuka Pharmaceuticals were aware, or should have been aware, that their dangerous drug had the potential of causing or contributing to compulsive behavior including uncontrollable gambling, obsessive sexual encounters, overeating, and binge shopping. Other commonalities in the lawsuit include:
- Plaintiffs claim that the drug companies failed to adequately study the antipsychotic medication to determine possible side effects and adverse reactions.
- Both Bristol-Myers Squibb and Otsuka Pharmaceuticals illegally promoted their product for off-label uses that had yet been approved by the Food and Drug Administration.
- Patients taking Abilify suffered significant harm that produced undesirable consequences including physical damages, psychological trauma, and financial devastation.
A $19.5 million settlement was reached in December 2016 with the U.S. Justice Department when Bristol-Myers Squibb acknowledged its unlawful marketing of its drug and its failure to label all of the product’s known risks. While the company was not willing to admit guilt, the settlement serves as an effective way to provide victims the financial compensation they deserve after filing in successfully resolving their Abilify lawsuit.
Do I Have an Abilify Claim for Compensation?
If you have experienced criminal, professional and domestic consequences caused by taking Abilify (aripiprazole) that resulted in bankruptcy, financial losses other life altering situation, our law firm is standing by to help. The reputable Abilify injury legal team at the Drug Law Center has years of experience in assisting injured victims and have the necessary knowledge in vast resources to fight aggressively against large pharmaceutical companies.
To ensure a successful resolution to your case and minimize your financial burden, we offer a “No Fee Guarantee” and will postpone payment for our legal fees until we obtain monetary compensation on your behalf. Contact us today to schedule a free initial consultation so we can begin the process of obtaining the monetary recompense your family deserves.