What Are the Common & Long Term Side Effects of Abilify? |

Abilify is an anti-psychotic drug that has been seen to cause depression, suicidal thoughts and violence. The FDA approved the use of Abilify in 2013 because it was deemed to be safe enough for long term usage, but there is a growing concern over side effects that have come up more extensively since the release of this drug.

The “most common meaning” of abilify is that it is a medication used to treat the symptoms of schizophrenia and bipolar disorder. It is also used as an antipsychotic treatment for people with schizophrenia who have not responded well to first-generation antipsychotics. Abilify has been shown to be effective at stabilizing mood and reducing the risk of suicidal thoughts, but can cause weight gain, increased cholesterol levels, and type 2 diabetes in some patients.

What Are the Common & Long Term Side Effects of Abilify? |

(As of March 13, 2018, this information has been updated.)

Abilify (aripiprazole) is an antipsychotic medication that is used to treat mental illnesses such schizophrenia, bipolar disorder, and depression. Advertisements for Abilify claim that the medicine works “like a thermostat to restore equilibrium” in the brain, although no one knows for sure, including drugmakers and the FDA.

While the mechanism of action of Abilify is unknown, a growing body of research shows that the way it affects the brain might lead to obsessive behavior, such as compulsive gambling. As a result, there have been financial losses and litigation.

Abilify may trigger obsessive behavior, according to a growing body of data.

Although direct-to-consumer advertising helped Abilify become the most popular medicine in the United States, the product literature for Abilify marketed in the United States did not include any warnings concerning compulsive gambling or other impulse control issues until 2016. On the other hand, warnings on Abilify packaging have been included in Europe and Canada for years.

Patients who lost a lot of money gambling while taking Abilify are now suing the drug’s producer, Otsuka Pharmaceuticals. You could have a case if you started gambling uncontrollably after taking Abilify. To discover out whether you are eligible for compensation, contact us for a free consultation.

Abilify’s Brief History

Abilify was developed by Otsuka Pharmaceuticals in Japan and is distributed in the United States by Bristol-Myers Squibb.

The medication was originally developed as a schizophrenia therapy and received FDA clearance for such usage in 2002. Abilify was licensed by the FDA to treat bipolar illness a few years later. Abilify was authorized by the FDA in 2007 as a supplement to existing drugs for the treatment of major depressive disorder.

Prior to that, the drug’s creators were attempting to increase Abilify sales by using it for new, but unapproved, purposes. Bristol-Myers Squibb was fined $515 million by the Justice Department in 2007 for selling Abilify “off-label” to children, adolescents, and geriatric dementia patients.

Sales of Abilify skyrocketed once it was approved for use in the treatment of depression. Bipolar disorder and schizophrenia impact just approximately 2.5 percent of Americans, making them a niche market. Depression affects 16 million people in the United States, or 6.9% of the population.


What-Are-the-Common-amp-Long-Term-Side-Effects-of Statista’s graph


Abilify’s sales skyrocketed when it was authorized to treat depression, thanks in large part to a $121 million per year direct-to-consumer advertising strategy that has been criticized for being too basic.

Abilify was the top-selling medicine in the United States in terms of sales by 2013-2014. Abilify sold $7.5 billion between October 2013 and September 2014, more than all other leading antidepressants combined.

During the same time period, scores of patients complained to the FDA regarding Abilify-related obsessive behavior. At least 59 instances of compulsive gambling were reported to the FDA between 2005 and 2014. More than 150 complaints of Abilify and gambling were received by the FDA in only the first half of 2015.

In the same year, the FDA wrote to Otsuka, claiming that its statements concerning Abilify were unjustified by science.

The scientific data tying Abilify to obsessive behaviors was examined by European and Canadian health authorities, and new warning labels for this possible side effect were imposed (Europe did so in 2012, and Canada in 2015). In 2016, the FDA mandated that obsessive behavior warnings be added to Abilify marketed in the United States.

The FDA received more than 150 complaints of Abilify and gambling in the first half of 2015.

Patients are now bringing lawsuits against the drug’s makers, alleging that they lost a lot of money gambling while on Abilify, and that the absence of a warning for this adverse effect was a marketing fault.

In May 2015, Otsuka’s Abilify patent expired in the United States, paving the way for a significant drop in sales as more manufacturers produce generic copies of the medicine.

What Is Abilify and How Does It Work?

Abilify imitates dopamine’s actions in the brain. Dopamine is a neurotransmitter that helps control the reward and pleasure areas of the brain. Dopamine regulates emotional reactions, allowing individuals to “not just recognize rewards, but to take action and move toward them,” according to Psychology Today.

The mechanism by which Abilify controls brain chemistry and helps to reduce brain disease symptoms is still partially known. As a result, it’s also unclear how the medication could lead to compulsive gambling and other compulsive behaviors.

Abilify imitates dopamine’s actions in the brain.

Dopamine deficiency may contribute to sadness, whereas dopamine excess can lead to psychosis and malfunction. Abilify helps to control mood by ensuring that dopamine levels are just right—not too much, nor too little. Or, as one Abilify TV advertisement described it, the medicine acts “like a thermostat to restore equilibrium” in the brain. “When essential brain chemical activity is too high, Abilify decreases it,” according to a print advertising. Abilify boosts critical brain chemical activity when it’s too low.”

These commercial promises, although enticing, are dubious, according to critics. The brain’s mechanisms are poorly understood, and the origins of mood disorders, including depression, remain unclear.

It’s hardly strange, therefore, that the mechanism of Abilify’s activity is likewise unclear. That’s exactly how the drug’s insert puts it: “The mechanism of action of aripiprazole… is uncertain.”

Is Abilify a Safe Drug?

After Abilify was licensed for depression and sales started to soar, Otsuka revealed in a 2012-2013 benefit-risk review report that the safety and effectiveness of aripiprazole as an add-on to antidepressants had not been studied in long-term controlled studies (the gold standard of clinical trials).

“There is minimal evidence that adding Abilify to antidepressants reduces symptom severity.”

“There is minimal evidence that Abilify contributes to symptom reduction when added to antidepressants,” another research stated, “and adverse effects are more common during Abilify augmentation therapy.” A analysis of all the randomized clinical studies comparing Abilify to other schizophrenia medications found that the data was of poor quality, fragmentary, and difficult to use clinically.

Meanwhile, despite the absence of scientific evidence, Otsuka continued to advertise the medicine as superior to rivals. “The totality of these claims and presentation is… deceptive since it indicates that Abilify provides benefits over other presently authorized therapies for bipolar disorder or [depression] when this has not been shown,” the FDA noted in a letter to the manufacturer in 2015.

Bristol-Myers Squibb agreed to a $19.5 million settlement with the US Justice Department in December 2016 for illegally promoting Abilify and downplaying the drug’s many hazards.

Is it possible that Otsuka paid doctors to promote Abilify?

In addition to pushing Abilify for off-label purposes and for permitted uses through simplistic and misleading promotional claims, Otsuka Pharmaceuticals paid clinicians to promote the medicine.

According to ProPublica, more than 21,500 physicians have received payments connected to Abilify totaling $10.6 million.


Has Abilify been linked to Obsessive-Compulsive Disorder?

Abilify has been linked to compulsive gambling and other compulsive behaviors including hypersexuality, binge eating, and binge shopping in a number of studies. The scientific data on Abilify and compulsivity was assessed by European and Canadian authorities, and it was determined that revised safety labeling was necessary.

In 2012, the European Union introduced warnings, and Canada followed suit in 2015. However, in the United States, the term “gambling” was not even included on the Abilify label until January 2016, more than 13 years after the medicine was licensed, and warnings concerning binge eating, shopping, and sex were not added until May 2016.

Abilify has been linked to compulsive gambling and other compulsive behaviors including hypersexuality, binge eating, and binge shopping in a number of studies.

When there is “reasonable evidence” of a causal relationship between a medicine and a side event, FDA rules mandate a warning. There is evidence linking dopamine agonists to obsessive behavior in the instance of Abilify going back to 2009, while aripirazole has been particularly connected to compulsive behaviors from at least 2010.

The likely causal association between Abilify and obsessive behavior is shown by a selection of research data. Consider the following scenario:

  • “Three instances of Aripiprazole-induced compulsive gambling are reported.” (Aripiprazole-induced pathological gambling: a report of three instances, Cohen et al., Current Drug Safety 2011; 6: 51-53)
  • “The findings do, however, point to a link between aripiprazole and a loss of impulse control in relation to their behavior.” 199 British J. of Psychiatry 158, 158-59 (2011) (Neil Smith et al., Pathological Gambling and the Treatment of Psychosis with Aripiprazole: Case Reports) (3 Cases)
  • “With this antipsychotic, physicians should inquire about obsessive behavior.” (Milton G. Roxanas, Pathological Gambling and Compulsive Eating Associated with Aripiprazole, 44 Australian & New Zealand J. of Psychiatry 291, 291; Milton G. Roxanas, Pathological Gambling and Compulsive Eating Associated with Aripiprazole, 44 Australian & New Zealand J. of Psychiatry 291, 291; Milton G. Roxanas (2010)

“Among 14 of the 18 international cases of compulsive gambling identified in a review of the scientific and medical literature, the behaviors resolved or improved when the treatment with aripiprazole was stopped or the dosage was reduced,” Health Canada says, “the behaviors resolved or improved when the treatment with aripiprazole was stopped or the dosage was reduced.”

Why did the FDA issue more Abilify cautionary statements?

The FDA issued a warning in May 2016 regarding Abilify’s impulse control issues, stating that the medicine is linked to “uncontrollable cravings to gamble, binge eat, shop, and have sex,” and announced the inclusion of additional warning labels concerning these compulsive behaviors.

Only after commencing Abilify therapy did patients with no past history of obsessive behaviors suffer overwhelming impulses.

Nearly 200 case reports of aripiprazole and impulse control issues were highlighted by the FDA, the majority of which were connected to compulsive gambling. Patients with no past history of compulsive behaviors had uncontrolled cravings only after beginning Abilify medication, according to the FDA. These uncontrolled cravings disappeared as soon as the amount was reduced or the medicine was stopped.

According to the FDA, if Abilify-related impulse control difficulties are not detected, they might cause damage to the patient and others. Patients who are having trouble controlling their impulses while taking Abilify should contact their doctor, according to the FDA.

What are the allegations in the Abilify lawsuits?

Our lawyers are now launching Abilify claims, arguing that Otsuka and Bristol-Myers Squibb knew — or should have known — that Abilify might promote compulsive behaviors like gambling. Furthermore, we believe that their inability to tell patients about this possible adverse effect has resulted in some patients gambling excessively, resulting in financial difficulty, mental pain, and other losses.

If you or someone you know took Abilify and developed a gambling addiction that resulted in severe financial losses, you may be eligible to file a lawsuit for compensation. To discover more about your legal options, contact us now.

Abilify is a medication used to treat schizophrenia and bipolar disorder. It has been linked to suicidal thoughts, depression, and other side effects. Reference: common meaning in english.

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