The Food and Drug Administration (FDA) has recently warned of cases in which patients taking the antipsychotic medication Abilify (aripiprazole) have experienced uncontrollable urges to gamble, which has deeply affected the lives of thousands of individuals and families.
Although pathological gambling was already listed as a reported side effect in the current aripiprazole drug labels, the FDA noted, “This description does not entirely reflect the nature of the impulse-control risk.”
As a result, the FDA is adding a new mandate to include the entire list of potential compulsive behaviors. These warnings will be added to the drug labels and the patient Medication Guides for all aripiprazole products.
Aripiprazole is sold under the brand names Abilify, Abilify Maintena, Aristada, and also as generics. It is manufactured by Otsuka Pharmaceutical Co. and Alkermes PLC.
Joseph Lyon is a highly-rated pharmaceutical attorney, representing clients in various class action and mass tort suits nationwide. Currently, Mr. Lyon is representing patients of Yaz, Abilify, Testosterone Therapy, and numerous other personal injury claims.
The FDA said in it last warning that anyone taking the medication, including children, can be affected by a compulsion to gamble, drink alcohol, eat or spend money excessively, as well as experience an increased impulse to engage in sex.
In the majority of reported cases, patients with no prior history of the compulsive behaviors listed above had uncontrollable urges soon after starting aripiprazole treatment.
In studies, within days to weeks of reducing the dose or discontinuing aripiprazole, these urges or compulsions are resolved completely. Some cases reported the return of compulsive behaviors when patients restarted aripiprazole.
Studies suggest these dangerous urges are not rare at all. In fact, as many as 10 percent of patients may experience issues with impulse control.
Thomas Moore, of the Institute of Safe Medication Practices (ISMP), said “It’s an astronomical rate, in terms of adverse event risk.”
Moore also notes that many events go unreported because many people are embarrassed to tell doctors about these kinds of pathological behaviors.
When considering the number of patients taking this particular drug, thousands who could be at risk. In 2015, approximately 7.7 million prescriptions for oral aripiprazole were dispensed. Around 1.6 million patients in the US received an outpatient prescription for aripiprazole.
Aripiprazole is used to treat certain mental disorders. Aripiprazole has been used to treat a number of conditions, including the following:
• Parkinson’s disease
• Restless leg syndrome
• Bipolar disorder
• Tourette’s disorder
• Depression (in combination with antidepressants)
The FDA Adverse Event Reporting System database and other literature available through mid-January 2016 identified 184 case reports indicating an association between aripiprazole and impulse-control problems.
This is not only a recent finding. Impulse-control disorders, and pathological behaviors such as compulsive gambling, shopping, eating, and hypersexuality, have long been reported in association with the use of dopamine agonist drugs. Such cases of impulse control have been reported to the FDA for the last 15 years, since the drug was approved in the US in November 2002.
From foreign and domestic reports, there are over 710 impulse-control disorder events reported in recipients of dopamine receptor agonist drugs.
The recent decision by the FDA further bolsters these prior concerns.
In its recent warning, the FDA said those taking Abilify, or any derivative of aripiprazole, should be watched by caregivers or doctors “in order to prevent or limit possible harm.” The agency recommends the following for patients and healthcare providers:
• Health care professionals should make patients aware of the risk when prescribing aripiprazole.
• Patients and caregivers should proactively monitor for changes in behavior or compulsive urges.
• If urges occur, consider reducing the dose or discontinuing the drug. However, patients should not suddenly stop taking their aripiprazole medicine without first talking to their health care professional.
If you or a loved one have suffered from unusual compulsive behaviors after taking Abilify and have questions about the legal remedies available to improve quality of life and medical care, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions.