Our lawyers are investigating the risk of side effects like compulsive gambling from Rexulti (brexpiprazole), a medication for adults with depression or schizophrenia.
What is Rexulti?
Rexulti® (brexpiprazole) is a medication made by Otsuka Pharmaceutical Co. Ltd. It was approved in July 2015 as an add-on treatment for adults with major depressive disorders who are also taking an antidepressant. Rexulti is also approved for schizophrenia.
What is the problem?
Rexulti is was introduced around the same time another antipsychotic medication called Abilify (aripiprazole) lost patent protection from competitors. Rexulti and Abilify are very similar medications, which is why experts are worried about a similar risk of gambling side effects. Furthermore, the label on Abilify warns that “pathological gambling” is a possible side effect.
Rexulti Gambling Warning Label
The Prescribing Information (PDF) for Rexulti recommends that patients talk to their doctor if they have a history of gambling or impulse-control disorders. The label does not list “gambling addiction” as a side effect of Rexulti.
Instead, the label warns that “pathological gambling” has been reported with other anti-psychotic medications:
“Post-marketing reports of impulse-control disorders including pathological gambling and hypersexuality have been reported in patients treated with another antipsychotic with partial agonist activity at dopamine receptors. Patients with a prior history of impulse-control disorder may be at increased risk and should be monitored carefully.”
Abilify and Compulsive Behaviors
In May 2016, the FDA ordered the manufacturers of Abilify to add a warning label about uncontrollable urges to gamble, eat, shop, and have sex. Hundreds of lawsuits have been filed by people whose lives were devastated by Abilify’s addictive side effects, especially those who lost massive amounts of money due to gambling addiction.
Rexulti Boxed Warnings
Rexulti has a “Boxed Warning” that it can increase the risk of stroke and death when it is used for the unapproved treatment of elderly adults with dementia-related psychosis.
Rexulti also has a “Boxed Warning” that it may increase the risk of suicidal thoughts or behaviors in children, teenagers, and young adults who are on antidepressants. Patients on Rexulti should be monitored for new or worsening suicidal thinking or behaviors.
Rexulti Side Effects
The most common side effects of Rexulti are weight gain and a disorder known as “akathisia,” which causes an inner sense of restlessness, such as feeling the need to move. These side effects were reported by over 5% of patients on Rexulti during clinical trials.
Rexulti is also associated with these severe side effects:
- Stroke, transient ischemic attacks, and death in elderly patients with dementia-related psychosis
- Neuroleptic malignant syndrome
- Tardive dyskinesia
- Metabolic changes (hyperglycemia, diabetes, weight gain, etc.)
- Blood disorders (leukopenia, neutropenia, agranulocytosis)
- Orthostatic hypotension and fainting
- Seizures
The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.
