FDA mandates label change to warn that compulsive behaviors are a side effect.
Abilify (Aripiprazole) is a commonly prescribed antipsychotic used to treat agitation caused by schizophrenia, bipolar disorder or major depression. The drug is effective at controlling symptoms of these mental disorders; however, it comes with a dangerous, side effect that many never see coming compulsive behaviors such as gambling, binge eating, excessive shopping, and hypersexuality.
The FDA now has mandated manufacturers, Otsuka and Bristol-Meyers to change the labeling to warn about compulsive behaviors. Those taking Abilify should monitor their behavior and if any excess urges become present to stop taking Abilify immediately.
How Does Abilify Work?
Abilify works differently than many other drugs in its class. Other drugs block chemical receptors in the brain for dopamine or serotonin to control symptoms. Aripiprazole works by either enhancing or inhibiting dopamine and serotonin levels to keep a balance. Many doctors call Abilify a stabilizer, which is why they prescribed it with other medications in an effort to enhance effectiveness.
This stabilizer effect is one reason doctors prescribe the drug so often, even for off-label use. Abilify isn’t like other drugs, so medical researchers are conducting independent clinical trials.
In some of these clinical trials, a scary side effect has emerged. Researchers speculate that since Abilify modifies brain receptors by manipulating the chemicals that regulate mood and behavior, these receptors might be over-stimulating the reward signals in the brain. Thus, causing compulsive behavior.
Compulsive Behavior Studies
Several studies are linking Abilify to compulsive behaviors such as pathological gambling in people with no previous history of this issue prior to taking the drug. In a 2013 French study, seven out of the eight patients who took Abilify developed sudden and compulsive gambling behaviors. This overwhelming drive to gamble was also seen in another study this time in England. Many of these patients felt completely preoccupied with thoughts of gambling. It was so severe that some patients even considered committing crimes for gambling funds.
The gambling becomes so intense that patients often seek professional help. The addiction can be so extreme that those taking Abilify continue the downward gambling spiral even if they cannot afford it. They max out credit cards, take out second mortgages on their homes and sometimes feel compelled to use unethical measures to get money to feed their addiction. Gambling becomes their sole reason to live.
In all cases, the compulsive behavior ceased after discontinuing Abilify or switching to another drug.
On May 3, 2016, the FDA released a warning to patients and doctors that Abilify may cause pathological gambling, overeating, hypersexuality and excessive shopping. The new impulse-control warnings are on the medication’s insert and label. Prior to the announcement, the drug’s manufacturers only reported incidences of compulsive gambling on the warning label.
Millions of Americans who take Abilify are affected by the warning. In 2015 alone, U.S. doctors wrote 1.5 million prescriptions. The drug made over $6.4 billion in sales as well.
Abilify manufacturers Bristol-Myers Squibb and Otsuka Pharmaceuticals paid more than $515 million in 2007 to settle accusations of marketing and bribing healthcare professionals to promote Abilify for off-label use. Otsuka Pharmaceuticals later paid an additional four million to resolve allegations. The companies were promoting Abilify to child psychiatrists, pediatric specialists, and nursing homes. Those who specifically would be greatly harmed by using Abilify.
In April 2015, the FDA issued a letter which stated Abilify’s promotional materials were “false or misleading because it makes misleading claims and presentations about the drug.” The FDA found the material misleading because it implies that Abilify offers advantages over other currently approved treatments for bipolar disorder or MDD when this has not been demonstrated.
According to the Department of Justice, Bristol-Myers Squibb continued to direct its sales force to promote Abilify for children, adolescents, and elderly patients. The sales force tried to drum up business in nursing homes for patients suffering from dementia-related psychosis even though the FDA mandated that Abilify packaging contains a “black box” warning over its use in the treatment of dementia-related psychosis.
In December 2016, Bristol-Myers Squibb reached a nearly $20 million Abilify settlement with 42 U.S. states and the District of Columbia to settle the accusations of illegal marketing.
Black Box Warnings
Currently, Abilify has black box warnings in three categories: elderly use, stroke, and suicidal thoughts.
If older adults use Abilify, it can increase their risk of death.
In clinical trials, older adults with dementia had an increased risk of potentially fatal strokes. Abilify should be used with extreme caution in older patients with Alzheimer’s disease.
In patients with depression, taking Abilify led to suicidal thoughts and behaviors most notably in patients under 24 years old.
We Want to Help Victims
It is your right to be informed about the long-term risks associated with the medications you take, and it is the responsibility of drug companies to provide this information. If you or a loved one has developed a compulsive behavior after taking Abilify, you should demand accountability from Bristol-Myers Squibb. Why weren’t you told?
We want to help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. You may be entitled to compensation for their injuries and damages. The types of losses that can be recovered include:
If a person dies from complications from a drug, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
If the conduct of a drug company in manufacturing and selling drug is found to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If you developed a compulsive behavior after taking Abilify, please speak to us to learn more about your rights.