By Jennifer Stanich-Banmiller, Founder
Periscope News Group
May 30, 2018
For patients with schizophrenia or bipolar disorder, just performing daily activities to live a normal life seems like a dream. Many times, medication seems like the best option to help individuals with mental disorders which has made Abilify one of the most popular drugs on the market. However, the FDA has published a safety communication that states that Abilify is linked to uncontrollable behaviors including compulsive gambling. Here’s what you should know before you or a loved one starts taking prescription Abilify.
The History Behind Abilify
Abilify (aripiprazole) is known as a second generation antipsychotic (SGA) or atypical antipsychotic and was initially created to treat schizophrenia. In 1972, Professor Arvid Carlsson proposed that schizophrenia could possibly be managed by regulating dopamine which helps to control the brain’s reward and pleasure centers. A common theory is that schizophrenia is the result of dopamine hyperactivity, so reducing this chemical could minimize the troubling effects of this disorder.
Otsuka Pharmaceutical began research on dopamine autoreceptor agonists in the late 1970s which led to the creation of aripiprazole. In 1999 they partnered with Bristol-Myers Squibb (BMS) for development completion, to obtain the required approvals, and finally to market aripiprazole in the U.S. and Europe under the Otsuka name. The FDA approved Abilify to treat schizophrenia in 2002 and in 2004 it was approved for bipolar disorder.
What is Schizophrenia?
Schizophrenia affects 1% of Americans and while that doesn’t sound like much, that’s still 2.4 million people. Genetics, environment, brain chemistry, and substance abuse are all considered to be possible causes of this mental disorder. A diagnosis of schizophrenia involves struggling with some of the following disorders for six months or longer:
- Hallucinations – Seeing things, hearing voices, or perceiving things that others cannot
- Delusions – False beliefs that aren’t changed even when given facts and new ideas
- Negative Feelings – This is sometimes mistaken for depression since it’s seems very similar. This includes feeling disconnected, unemotional, or or showing little interest in life.
- Disorganized Thinking – This symptom makes remembering things difficult or causes the person to have a hard time completing tasks or sharing understandable thoughts.
What is Bipolar Disorder?
If you have been diagnosed with bipolar disorder, you’re not alone. Bipolar disorder affects about 5.7 million American adults, or about 2.6% of the U.S. population 18 and older. Like schizophrenia, it’s believed that genetics, brain chemical makeup, and environment may all be contributing factors. Bipolar disorder is diagnosed when the following symptoms are present:
- Manic episodes that last at least one week where a person is high spirited and more active than normal. This can include talking fast and loud, being overly generous, needing less sleep, or scheduling more activities that anyone can balance.
- Major depressive episodes that can last about two weeks and involve sadness or despair, feeling worthless or guilty, having an increase or decrease in appetite, experience a loss of energy and sleeping more, or having thoughts of death or suicide.
How Does Abilify Work?
Aripiprazole works differently than other antipsychotic medications in that past ones were “dopamine antagonists” and Abilify is a “dopamine system stabilizer”. Dopamine antagonists shut down dopamine which have been linked to side effects involving movement disorders. Dopamine system stabilizers monitor the dopamine receptor strongly enough to reduce excess dopamine that causes psychosis (a hindered view of reality), while at the same time allow enough dopamine-like activity to prevent movement disorders. (Movement disorders are a big concern with dopamine antagonists, so many medical professionals were excited when Aripiprazole entered the market.) It is also said that Abilify regulates the serotonin in your brain. Serotonin is considered to be a mood stabilizer that helps reduce depression and anxiety.
However, the exact way that Abilify works in the brain is still unclear. The above theory is just that: a theory. This drug was based on the assumption that an excess of dopamine causes hallucinations, delusions, unorganized thoughts, and the other symptoms mentioned concerning schizophrenia and bipolar disorder. The FDA even states, “The mechanism of action of aripiprazole, as with other drugs having efficacy in schizophrenia and bipolar disorder, is unknown.”
So the question at hand is, if we don’t know how a medication works, can we really assess the potential problems that can occur from taking it? Are these patients being deemed a testing ground to see by chance what works and what doesn’t?
Abilify and Compulsive Behaviors
So how can a pill cause someone to have a gambling addiction? Abilify is a second-generation antipsychotic (SGA) medication that is called “a dopamine-serotonin system stabilizer” that either enhances dopamine and serotonin levels or inhibits them to keep them in balance. Applying the above theory, Dopamine is known as the “reward” chemical in the brain that induces pleasure. Various levels dopamine are believed to affect your mood, self-control, ability to focus, sleeping patterns and other important functions. Too much dopamine may stimulate problematic behaviors such as addictions to shopping, sex and yes, gambling.
A Timeline of Evidence
The underlying problem is that Otsuka Pharmaceuticals and BMS knew about the potential for compulsive behaviors associated with Abilify and yet they didn’t warn them. If there was a warning given with the medication, at least the patient would have been able to make an educated decision as to whether or not they wanted to take this medication. A warning would also have altered patients to look for the warning signs of destructive behavior before it resulted in massive amounts of dollars lost due to gambling. Here is a timeline showing critical events and proof that Otsuka and BMS put profits over people:
- November 2012 – The European Medicines Agency (which is equivalent to our FDA) required Abilify warnings for the risk of pathological gambling for patients and medical providers in Europe.
- May 2013 – The American Psychiatric Association upgraded pathological gambling from an impulse control problem to an addiction.
- August 2013 – December 2014 – Over $10 million in payments relating to Abilify were given to 21,155 physicians in the U.S.
- November 2015 – Canada requires Abilify to update their warning label to include, “an increased risk of impulsive behaviours of pathological gambling and hypersexuality.”
- January 2016 – Pathological gambling was added to the postmarket experience section of the label, but no mention was made of gambling concerns in the patient medical guide where patients and doctors are most likely to look.
- January 12, 2016 – The first Abilify lawsuit was filed in the District of Minnesota.
- May 3, 2016 – The FDA issues a warning that Abilify was associated with “compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex.”
- August 2016 – BMS finally adds Abilify warnings regarding compulsive gambling and other compulsive behaviors.
- April 27, 2018 – Although Abilify cases were scheduled to go to court in the summer of 2018, the first three cases were settled in April 2018. This rarely happens!
- September 2018 – A Global Settlement is set to take place and once this is finished, the possibility to make a claim for financial compensation may be gone!
That’s almost fours years between when Europe was warned verses the U.S!
Complications Associated with Abilify
When most people hear that a medication can cause someone to be a compulsive gambler, they automatically tend to be skeptical. It does sound like the medication is being the scapegoat or excuse for someone who can’t exercise some self-control. However, there is much scientific evidence proving that Abilify is linked to destructive behaviors which led the FDA to publish this Safety Warning on May 3, 2016:
“The U.S. Food and Drug Administration (FDA) is warning that compulsive or uncontrollable urges to gamble, binge eat, 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. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized.”
It is also important to note that while binge eating, excessive shopping, and an increased desire for sex are listed as other uncontrollable behaviors while taking Abilify, Abilify Maintena, Aristada, and generics, only compulsive gambling while taking Abilify is currently compensable and are the only lawsuits that are being filed for multidistrict litigation.
Delayed Warning Equals More Profits
The European Medicines Agency required Abilify warnings for the risk of pathological gambling in November 2012 but Abilfy didn’t have a warning in the U.S. until May 2016. That’s four years where American patients were in the dark! And why the delay? Money, plain and simple. Abilify raked in $7.5 billion from October 2013 through September 2014 and it wasn’t even one of the most-prescribed medication. One reason for that high number is that it costs about $800 per bottle of 30 tablets. Abilify is also the 8th most profitable drug of all time. From when it was introduced to the market in 2002 until 2017, U.S. sales alone totaled $51.34 billion (yes, BILLION). The question here is this: how can a drug that was created and approved to help patients who are battling schizophrenia and bipolar disorder – approximately 3% of the population – become the highest selling drug of 2014?
One answer is the over-the-top marketing campaign that was launched by Otsuka and BMS. Early print advertisements promoting aripiprazole for bipolar disorder claimed: “When activity of key brain chemicals is too high, Abilify lowers it…. When activity of key brain chemicals is too low, Abilify raises it.” Remember when we said that the FDA report said that the mechanisms of Abilify were “unknown?” This is just a theory of how this drug works to manage psychiatric disorders, but it is not a proven fact supported by the FDA or peers in the field. While this ad appealed to countless patients, many are now speaking out saying this ad was falsely advertising the benefits of Abilify which caused it to become a billion dollar pill.
Let’s also take this inconsistency one step further: many studies have shown that serotonin – the chemical that was attributed to balancing moods – may not be as influential on depression and anxiety as we once thought. “While neuroscience is a rapidly advancing field, to propose that researchers can objectively identify a ‘chemical imbalance’ at the molecular level is not compatible with the extant science,” explains Dr. Jeffrey Lacasse and Dr. Jonathan Leo. “In fact, there is no scientifically established ideal “chemical balance” of serotonin, let alone an identifiable pathological imbalance. To equate the impressive recent achievements of neuroscience with support for the serotonin hypothesis is a mistake.”
Current Abilify Lawsuits
But here’s the exciting part: on April 27, 2018, three cases settled BEFORE the summer 2018 trial. This rarely happens in Multidistrict Litigation (MDL) cases which indicates that future cases will be short. A Global Settlement was announced in May 1, 2018 so only two to three months may be left to make a claim. Once this settlement is finished, you may not have the opportunity to receive financial compensation again! If you or a loved one had a gambling addiction while taking Abilify, you should contact Periscope Group TODAY. You weren’t warned of the potential for uncontrollable behaviors and the pharmaceutical companies made billions without warning patients. They should pay for the financial hardships that they’re responsible for.
For more information about Abilify, visit www.periscopegroup.com/abilifyhelp now. For interviews or to tell your story,contact Jennifer Stanich-Banmiller at (925) 964-1485 or at email@example.com.