On February 9, 2018, the FDA added the warning and instructions below to the approved drug label for brexpiprazole (brand name Rexulti). The Prescribing Information for aripiprazole (brand name Abilify) has carried the exact same warning since 2016. The third dopamine partial agonist, cariprazine (brand name Vraylar) does not carry this warning as of February 2018, but I would assume that it may have similar risks.
Note: Emphasis in red on this page is not from the FDA. It has been added by us.
Note that the FDA is not simply letting us know that this side effect can occur. It is instructing us that every patient prescribed brexpiprazole AND caregivers must be told about this possibility and then, in follow up, patients or their caregivers must specifically be asked about this.
I have one question on this: How long does the follow up visit need to have time to education every patient on this and all other possible side effects AND to specifically ask patients if they have had this and other side effects?
“Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking REXULTI. Other compulsive urges, reported less frequently, include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviors.
Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with REXULTI.
In some cases, although not all, 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. Consider dose reduction or stopping the medication if a patient develops such urges.”
The following text was added to the Patient Counseling Information in the drug label:
“Pathological Gambling and Other Compulsive Behaviors
Advise patients and their caregivers of the possibility that they may experience compulsive urges to shop, intense urges to gamble, compulsive sexual urges, binge eating and/or other compulsive urges and the inability to control these urges while taking REXULTI. In some cases, but not all, the urges were reported to have stopped when the dose was reduced or stopped.”
A 2016 Drug Safety Communication from the FDA about this risk with aripiprazole gave some additional guidance about who is at particularly higher risk, but that includes a lot of patients.
“Closely monitor for new or worsening uncontrollable urges in patients at higher risk for impulse-control problems. These include those with a personal or family history of obsessive-compulsive disorder, impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse, or other addictive behaviors.”
The Medication Guide
When brexpiprazole (Rexulti®) is dispensed by the pharmacy, the patient is given a document called the Medication Guide that was also revised in February 2018. It now tells patients about this potential side effect, but very briefly:
“Unusual urges. Some people taking REXULTI have had unusual urges, such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges. If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.”
But, the Medication Guide is not simply up to the pharmacies to dispense and for patients to read. In the Medication Guide for brexpiprazole, the FDA instructs that we must, “Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide).”
In the Medication Guide for aripiprazole, the FDA states, “The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents.”
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