The Wonder Drug?
Abilify (aripiprazole) is classified as an antipsychotic drug most often prescribed to treat schizophrenia, bipolar disorder, and depression. Otsuka Pharmaceuticals originally developed the drug and, with help from Bristol Myers Squibb Co., heavily marketed and commercialized Abilify usage. Bristol Myers proudly promotes Abilify as its number one selling product. In a 2014 Otsuka press release, the company reported revenues of $4.2 billion for 2012 and $4.7 billion for 2013.1
Otsuka and Bristol-Meyers’ Failure to Warn About Compulsive Gambling
In October 2012, Europe demanded an additional warning be added to Abilify. The demand was a result of the European Medicines Agency report showing a positive link between aripiprazole and possible pathological gambling. Health Canada conducted its own review of Abilify in November 2015, also finding a link between aripiprazole usage and a possible risk of pathological gambling.
Both Europe and Canada issued additional warnings as follows:
- Pathological gambling
- Post-marketing reports of pathological gambling have been reported among patients prescribed aripiprazole, regardless of whether these patients had a prior history of gambling. Patients with a prior history of pathological gambling may be at increased risk and should be monitored carefully.
In the United States, Otsuka and Bristol-Meyers Squibb have failed to provide a warning about Abilify and possible pathological gambling. This is despite Otsuka’s admitted knowledge of pathological gambling’s possible link to Abilify, which was reported in their September 2011 6-Month Periodic Safety Update Report to the European Medicine Agency. The report acknowledged a total of 23 “serious” reports of pathological gambling while taking Abilify. In the medical assessment of the reported pathological gambling cases, “Defendants concluded that a casual role of aripiprazole [Abilify] could not be excluded”.2
FDA Requires Warning
On May 3, 2016 the FDA required that a warning be added to the Abilify label directing patients and caregivers to monitor experiences of uncontrollable behavior while taking Abilify. The warning also specifies that doctors must notify patients of these additional risks and specifically ask patients about any new or increasing urges while they are being treated with Abilify.
On August 23, 2016 an additional update was made to the Abilify label citing pathological gambling as the main adverse experience Abilify patients may encounter while taking the drug. The updated label also notes, “... urges were reported to have stopped when the dose was reduced or the medication was discontinued. Compulsive behaviors may result in harm to the patient and others if not recognized.”
Abilify’s Effect on the Brain
In the medical world, aripiprazole is classified as a partial dopamine agonist with two different chemical receptors, D2 and D3. A wide range of scientific literature can already be found in regard to dopamine manipulation and its correlation to compulsive gambling and other reward seeking activities.3 The attorneys at GoldenbergLaw previously represented individuals who developed a pathological gambling habit as a result of taking Mirapex, a Parkinson Disease medication also classified as a dopamine agonist.
Most dopamine agonists, like Mirapex, only contain D2 receptors, therefore the D3 receptors’ presence in Abilify’s chemical composition presents an additional challenge in understanding how the drug actually works. Otsuka and Bristol-Myers Squibb have admitted to a lack of understanding about Abilify’s long term effect on the brain.4 In a Product Monograph on Abilify produced by Bristol-Myers Squibb Canada, the manufacturer explicitly states:
“The safety and efficacy of ABILIFY as adjunctive treatment in MDD have not been systematically evaluated beyond 6 weeks.”5
What Injury is Potentially Caused to Abilify Users?
Compulsive gambling is a potentially dangerous, unwarned side-effect of Abilify and it can have a devastating effect on some people. Some people begin to gamble uncontrollably while taking the drug. It may start with a visit to a casino, buying lottery tickets, or playing at an online casino, but because of the drug’s effect on the brain, the person cannot stop gambling. This often leads to daily compulsive gambling where savings accounts and 401Ks are drained. People begin borrowing money from credit card companies, taking out loans, and shattering the trust of their family and friends. They feel worthless, depressed and their financial losses are crushing. Most of those afflicted have never experienced these problems before taking Abilify. Once Abilify is discontinued, the gambling urges often will disappear in a short time.
Uncontrollable Gambling Problems?
If you or a loved one has experienced uncontrollable gambling behavior while taking Abilify and has lost at least $30,000, please call GoldenbergLaw for a free phone consultation. You are not alone. Our attorneys and staff have 30 years of experience in handling lawsuits against large pharmaceutical companies and will do everything possible to ensure you are fairly compensated for your losses. There is no fee if we do not recover for you. Please call us at 612-436-5026 for a free consultation.
2 Id. *n. 36
3 Id. *n. 33
4 Bristol-Myers Squibb Canada (May 27, 2013). Product Monograph: ABILIFY. Retrieved from: http://otsukacanada.com/docs/default-source/default-document-library/product-monographs/abilify_pm_e_27-may-2013_app_cln_dist.pdf?sfvrsn=2
5 Bristol-Myers Squibb Canada (May 27, 2013). Product Monograph: ABILIFY. *p. 4. Retrieved from: http://otsukacanada.com/docs/default-source/default-document-library/product-monographs/abilify_pm_e_27-may-2013_app_cln_dist.pdf?sfvrsn=2