The antipsychotic medication Abilify (generic: aripiprazole) has been linked to an increased risk for type 2 diabetes and uncontrollable behaviors such as compulsive gambling, binge eating and hypersexuality.
Free Confidential Lawsuit Evaluation: If you or a loved one developed type 2 diabetes after taking Abilify (generic: aripiprazole), you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Update: Bristol-Myers Wants Abilify Gambling Lawsuits Centralized in Florida
October 3, 2016 – Bristol-Myers Squibb and Otsuka Pharmaceutical Co. are requesting the Northern District of Florida as the appropriate venue in the upcoming multidistrict litigation (MDL) for federal lawsuits alleging compulsive gambling side effects from Abilify. The jurisdiction was originally proposed by a couple who filed one of the dozens of lawsuits alleging that the defendants failed to adequately warn about the risk of pathological gambling from Abilify, according to Law360.
What is Abilify?
Abilify is an antipsychotic drug that has been approved for the treatment of schizophrenia, bipolar disorder and depression when the patient’s main antidepressant is not effective. The drug may also be used to treat the symptoms of autistic spectrum disorders (ASDs) in pediatric patients. Aripiprazole, the active ingredient contained in Abilify, works by stabilizing dopamine and serotonin (5HT) receptors in the brain. Abilify was developed by the Japanese pharmaceutical company Otsuka, and is jointly marketed in the U.S. by Bristol-Myers Squibb (BMS) and Otsuka America.
Abilify and Type 2 Diabetes
The off-label promotion of Abilify has earned billions for Bristol-Myers and Otsuka over the past decade. However, recent studies have found that children face an increased risk of developing type 2 diabetes when they take Abilify. As a result, product liability lawyers around the country are helping those affected file an Abilify diabetes lawsuit.
In August 2013, researchers at Vanderbilt University, the Mayo Clinic and Columbia University published a study which found that children who take atypical antipsychotic drugs like Abilify have a threefold increased risk of developing type 2 diabetes. While previous studies have identified the link between antipsychotics and diabetes, this new study is the first large, well-designed study to look at the risk in pediatric patients. The researchers noted that the use of these medications for non-psychosis-related disorders in children now accounts for the majority of prescriptions.
For the study, researchers looked at medical records for TennCare youths ages 6-24 from 1996 to 2007. During that time, pediatric patients who were prescribed atypical antipsychotics for attention, behavioral or mood disorders, were compared with other children who were prescribed specifically-approved drugs for those disorders. The study found that those who used antipsychotics had a threefold increased risk of developing type 2 diabetes in the following year, with the risk increasing as the dosages were increased. The increased risk persisted for at least one year after the drugs were discontinued.
The study’s authors urged doctors and parents to carefully examine alternatives to antipsychotic use in children:
“This is particularly important for high-risk children, for example, those with elevated weight. Children should be monitored carefully for metabolic effects predisposing them to diabetes, and use of the drug should be at the lowest possible dose for the shortest possible time,” said Wayne A. Ray, Ph.D., senior author of the study.
Type 2 Diabetes Symptoms
- Increased thirst and frequent urination
- Increased hunger
- Blurred vision
- Slow-healing sores or frequent infections
- Areas of darkened skin
Abilify Side Effects
In addition to being linked to an increased risk for type 2 diabetes, Abilify may cause the following side effects in certain users:
- Difficulty speaking
- Loss of balance control
- Muscle trembling, jerking, or stiffness
- Shuffling walk
- Stiffness of the limbs
- Twisting / uncontrolled movements of the body
- Compulsive behavior
- And more
Abilify and Compulsive Behavior
Studies have found that Abilify may affect impulse control, increasing the risk of gambling addiction and other unusual behaviors that can have a devastating impact on a person’s family, employment, financial position and overall quality of life. As early as 2009, research identified a potential risk of impulse control and gambling addiction among users of dopamine receptor agonists like Abilify when used to treat Parkinson’s disease. In a Mayo Clinic study, researchers found unusually high rates of compulsive syndrome, including pathologic gambling, hypersexual behavior or a combination of the 2 problems.
Then in October 2014, a study published in JAMA Internal Medicine found additional signs of impulse control in patients treated with Abilify, which may result in abnormal behavior such as gambling addictions, risky sexual behavior and even compulsive shopping.
Atypical Antipsychotics Linked to Weight Gain, Other Outcomes in Children
In October 2009, a study published in the Journal of the American Medical Association (JAMA) identified a link between atypical antipsychotics like Abilify and significant weight gains in pediatric patients. Researchers at the Zucker Hillside Hospital in Queens, New York, noted 10-to-13 pound gains in children during their first 3 months of treatment with Abilify.
“Weight gain was pervasive even in medications usually considered to be weight neutral in adults,” said Dr. Christoph Correll, an Albert Einstein College of Medicine psychiatrist and lead author of the study. “The worry is that weight gain sustained over long periods of time can cause adverse outcomes like diabetes and heart attacks and strokes.”
Study Finds American Children Most Likely to be Prescribed Antipsychotics
A recent study conducted by researchers in the U.S., Germany and The Netherlands found that American children are approximately three times more likely to be prescribed antipsychotic medications compared to their European counterparts. Researchers attributed the differences to regulatory practices and cultural beliefs about the role of prescription drugs in treating children’s psychological problems.
“Direct to consumer drug advertising, which is common in the U.S., is likely to account for some of the differences. The increased use of medication in the US also reflects the individualist and activist therapeutic mentality of US medical culture,” said lead researcher Julie Zito.
Antipsychotic Prescription Rates Skyrocketing in U.S.
Experts estimate that about one million American children are treated for schizophrenia, and prescription rates for atypical antipsychotic drugs have increased by more than fivefold in the last 15 years. These medications are being increasingly prescribed to treat outbursts and aggression in pediatric patients with a wide range of diagnoses representing about 80% of the prescriptions written for autism, ADHD, bipolar disorder, depression and anxiety, despite the drugs’ potential side effects. Some of these uses are “off-label”, and have not been approved by the FDA.
FDA Investigates Abilify Diabetes Link in Children
Between 2008 and 2009, FDA received a number of adverse event reports in children aged 6-17 who were prescribed second-generation antipsychotic medications. The report states that the injuries most commonly associated with the drugs included “Type I/II diabetes, weight gain, and high cholesterol/triglycerides.”
In patients treated with Abilify, the cases included:
- A 12-year-old girl who was prescribed the drug for bipolar disorder developed type 2 diabetes and gained 150 pounds over a period of 1 year, reporting blood glucose levels of 195-305.
- A 17-year-old boy who took Abilify for bipolar disorder was diagnosed with diabetes and gained 14-40 pounds.
- A 14-year old male Abilify user presented with “Polydipsia, polyuria, diabetes mellitus, fatigue, hyperglycaemia, ketoacidosis, pollakiuria, urine abnormality, vision blurred, ketonuria, type 1 diabetes mellitus, [and] weight decreased”.
Click here to view the full FDA Adverse Event Report on Atypical Antipsychotics Among Children (2008-2009)
Judge Rejects Otsuka’s Bid to Take Abilify Rival Off Market
August 1, 2016 – A federal judge has rejected a lawsuit by Otsuka Pharmaceutical Co. to remove a competitor of Abilify from the market, according to Reuters. U.S. District Judge Ketanji Brown Jackson ruled Thursday that the FDA was correct in determining that Otsuka’s statutory exclusivity period for Abilify Maintena does not block a similar drug with a different active ingredient.
Abilify Labels Updated to Include Impulse-Control Problem Warning
May 3, 2016 – FDA is requiring new warnings to be added to the labeling of aripiprazole-containing antipsychotic medications (Abilify, Abilify Maintena, Aristada) regarding compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex. The agency warned that the impulsive behaviors, though rare, may cause harm to the patient or others if not identified. These problems were reported to have ended upon discontinuing the medication or reducing the dose, according to the FDA.
FDA Rejects Abilify/Ingestible Sensor Combo
May 2, 2016 – The first U.S. regulatory test for a drug that incorporates medication adherence technology has been rejected, according to FierceMedicalDevices. FDA issued a complete response letter to Otsuka Pharmaceutical and Proteus Digital Health for their drug/device combination of Abilify with Proteus’ ingestible sensor. The agency is seeking data on the performance of the product under the specific conditions in which it is likely to be used, as well as further human factors investigations to evaluate use-related risks and confirm that users can use the device safely and effectively.
Abilify Diabetes Lawsuit Filed in NY
In August 2014, a New York woman filed a lawsuit against Bristol-Myers and Otsuka alleging that the companies failed to warn that Abilify increases the risk of type 2 diabetes in pediatric patients by nearly tenfold. The suit, which was filed on behalf of Cheyenne Beth Confer, claims that the recommended dose of Abilify increases a child’s risk for diabetes 7.72 times above normal, but the manufacturers failed to update the drug’s warning label with information about the severity of this risk.
According to the lawsuit, Confer was 15 when she was prescribed Abilify for depression, an off-label use. Within six months, she gained 30 pounds and was diagnosed with type 2 diabetes. The manufacturers claim that there is no significant difference in blood glucose levels between Abilify users of any age and those who took placebos. However, since at least 2005, BMS and Otsuka were aware of studies and other data that pointed to an increased risk of diabetes in pediatric patients who were prescribed Abilify, the complaint alleges. Children are allegedly more sensitive to Abilify’s metabolic effects than adults, and gain weight at a faster rate.
“Defendants’ labeling for Abilify entirely omits more than 12 years of scientific evidence,” the lawsuit alleges. “The labeling is outdated, incomplete and materially false and misleading as it pertains to the diabetes risk to children and adults.”
The case is: Cheyenne Beth Confer v. Bristol-Myers Squibb Co. et al., case number 158295/2014, in the Supreme Court of the State of New York, County of New York.
Has There Been a Recall?
As information about Abilify’s side effects continues to surface, many have questioned whether its minimal health benefits outweigh the risks, and whether the drug should be recalled. At this time, no recall has been issued for Abilify, and there are no indications that the FDA is planning to remove the drug in the near future. However, the manufacturer may be required to provide stronger and more effective warnings for the public and medical communities.
Abilify Settlement Information
Although Abilify has been linked to a host of serious side effects, no lawsuit concerning patient harm has resulted in a settlement via trial by jury. However, Bristol-Myers Squibb was the target of an investigation by the U.S. Justice Department in 2006-2007. Among the charges detailed in the case were accusations that the company aggressively marketed Abilify for non-FDA approved (‘off-label’) uses. While an Abilify dosage is only approved to treat schizophrenia, bipolar disorder and major depression, doctors were encouraged to prescribe it to children, as well as elderly patients with dementia.
Do I Have an Abilify Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Abilify Lawsuits. We are handling individual litigation nationwide and currently accepting new diabetes and compulsive gambling cases in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured by Abilify side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.