Abilify

Abilify, technically arpiprazole, is a antipsychotic medication that treats disorders like schizophrenia and depression. The drug is advertised as being able to reset the body’s ‘thermostat’ but the precise mechanisms of action are unknown. What this means in simple terms is that Abilify works through unknown methods, meaning that if you ingest it, you can’t be precisely sure how it is affecting the body.

This may sound worrying but it is actually true of many medications and drugs that we take today. What’s more worrying is that increasingly, research is suggesting that Abilify might cause a range of health problems such as compulsive gambling and other forms of addiction. This has led to some victims finding themselves on the wrong side of lawsuits or experiencing significant financial losses.

Despite this, Abilify was at one point the top selling drug in the USA. This was the result of aggressive direct-to-consumer marketing and it wasn’t until 2016 that packets began to include warnings regarding the possible side effects. This was despite the fact that European and Canadian manufacturers began including these warnings years earlier.

As a result, many victims of Abilify are now suing the manufacturer Otsuka Pharmaceuticals. If you used Abilify and found that it affected your behavior in negative ways, then you too may be entitled to compensation. Schedule a case review to learn more.

Abilify is manufactured by the Japanese firm Otsuka Pharmaceuticals and was marketed in the USA by Bristol-Myers Squibb.

The drug was created in order to treat schizophrenia and gained approval from the FDA in 2002. Several years later, the drug was approved for treatment of bipolar disease and in 2007, it was approved for major depressive disorder.

Before this, the manufacturers sought to expand Abilify sales via unapproved uses. Bristol-Myers Squibb was fined $515 million in 2007 after marketing the product to children, adolescents and dementia patients for ‘off-label’ uses.

Sales began to reach their apex only once the drug was approved for depression. Bipolar disorder and schizophrenia are much rarer conditions, affecting only 2.5% of Americans. Meanwhile, depression affects a huge 6.9% of the population.

Helping push sales further was a $121 million-per-year advertising campaign, which has since garnered criticism for being overly simplistic.

By 2013, Abilify was outselling all other drugs in the US and from October 2013-September 2014 it managed to accrue a huge $7.5 billion in sales. That is more than all other anti-depressants combined!

During this time, the FDA was beginning to receive many complaints regarding compulsive behaviors seemingly resulting from Abilify use. Between 2005 and 2014, at least 59 cases were brought to the FDA and it is highly likely that there were many more that never came to light. In the first half of 2015, the organization received a huge 150 reports regarding gambling.

The FDA also submitted a letter to Otsuka that year, stating that its claims about Abilify were unsubstantiated.

It was at this time that the European and Canadian health authorities enacted the warning labels mentioning the potential side effects. This did not happen in the USA until 2016.

Patients are now filing lawsuits for the damages they received and the losses they made as a result of gambling. In 2015, Otsuka’s patent for Abilify expired, opening the floodgates for many more manufacturers to release generic versions of the drug.

As mentioned, the full mechanisms of action are not fully known for Abilify. This means that we can’t safely rule out potential side effects, or confidently make claims about the health benefits.

What we do know, is that Abilify mimics the role of dopamine in the brain. Dopamine is a highly important neurotransmitter that is involved in reward-motivated action. Dopamine is released when the brain is working toward a reward and when we believe we are doing something of importance. This helps us to stay focussed and motivated and it encourages the formation of new neural pathways to help us re-enact that behaviour in future.

Low levels of dopamine have been suggested as one potential cause of depression, whereas excessive amounts can lead to psychosis. Abilify aims to help ensure that levels of dopamine in the brain are correct. This is where the company’s ‘thermostat’ analogy comes into play.

But this is a drastic oversimplification and a truly unsubstantiated claim.

The problem is that increasing dopamine can also lead to unwanted behaviors, as the brain mistakes more menial tasks for being rewarding and beneficial. Abilify has no way of knowing the precise amount of dopamine in the brain and therefore does not really work as a thermostat at all – it is more akin to simply turning up the temperature without knowing what the temperature is currently.

This is especially pertinent seeing as many other things can cause depression – such as pro-inflammatory cytokines (brain inflammation) or low serotonin. It may be that the patient’s levels of dopamine are just fine before they start taking the medication!

Dopamine also has different roles and quantities depending on the brain region that it is released in. Only certain neurons contain dopamine receptors and these tend to be clustered in specific brain regions. Raising dopamine across the entire brain will have numerous knock-on effects that we can’t predict or fully understand yet.

Then there’s the fact that you can’t simply increase one neurotransmitter without expecting it to affect the production of others. Increasing dopamine for example will also increase other ‘stress hormones’ like cortisol and norepinephrine.

Not only that, but increasing dopamine through unnatural methods can actually lead to production being permanently downregulated in the brain. In short, the brain can detect a ‘surge’ in dopamine and respond by producing less naturally. This is called ‘tolerance and dependence’.

In short, the FDA concluded in its 2015 letter that:

“The totality of these claims and presentation is misleading because it implies that Abilify offers advantages over other currently approved treatments for bipolar disorder or depression when this has not been demonstrated.”

In 2016, Bristol-Myers Squibb reached a $19.5 settlement for this unlawful marketing and for downplaying the risks.

Not only this, but it has also been found that Otsuka-Pharmaceuticals has been guilty of paying doctors to promote the drug. ProPublica reports that over 21,500 doctors received $10.6 million for recommending Abilify.

This is all before you consider the numerous studies that show a link between Abilify and compulsive gambling, hyper-sexuality, binge eating and binge shopping.

The European authorities considered evidence on the risk of compulsivity linked to Abilify and found that the substance should include updated safety labelling. The EU added these warnings in 2012 and Canada did likewise.

Here are just a few snippets from studies looking at the link between compulsive behavior and Abilify use:

• “The observations do, however, indicate an association between aripiprazole and a reduction in the impulse control relating to their behaviour.” (Neil Smith et al., Pathological Gambling and the Treatment of Psychosis with Aripiprazole: Case Reports, 199 British J. of Psychiatry 158, 158-59 (2011) (3 Cases)
• “We report 3 cases of Aripiprazole-induced pathological gambling.” (Cohen, et al., “Aripiprazole-induced pathological gambling: a report of three cases”, Current Drug Safety 2011; 6: 51-53)
• “clinicians should ask about compulsive behaviour with this antipsychotic” (Milton G. Roxanas, Pathological Gambling and Compulsive Eating Associated with Aripiprazole, 44 Australian & New Zealand J. of Psychiatry 291, 291 (2010)

Health Canada has also observed that 14 of the 18 international cases of compulsive gambling identified in a review of the literature found that ceasing use of aripiprazole helped to reduce the behavior.

If you think that you may have been negatively affected by using Abilify, then you may be able to file an Abilify lawsuit. We are representing clients and allege that Otsuka and Bristol-Myers Squibb understood (or should have been aware of) the compulsive behaviors caused by the medication. We believe that the failure to warn of these side effects has resulted in serious consequences for many users.

If you would like to learn more then get in touch today at [PHONE] and we will happily discuss your case with you. You could be entitled to compensation and you could help countless others from suffering the same consequences.