Rexulti Gambling Risks Lead to Concerns About Abilify Replacement Drug

Although Rexulti was recently introduced as a superior alternative to Abilify, a recent label warning update suggests that the drug may carry the same risk of gambling addition seen with Abilify

The FDA has granted supplemental approval (PDF) for new label warnings for the Otsuka drug Rexulti, which was the drug manufacturer’s replacement for Abilify, as the blockbuster drug lost patent protection.

Rexulti (brexpiprazole) was approved by the FDA in 2015, for treatment of major depressive disorders and schizophrenia. It already carried boxed warnings that it could increase the risk of death of elderly patients, could increase the risk of suicidal thoughts in patients 24 years old and younger, and that its safety and effectiveness had not been established in pediatric patients. However, the drug makers did not warn about the potential Rexulti gambling risks, even though the warning label for Abilify was updated in May 2016.

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On February 9, the FDA issued a supplemental approval for a new section of Rexulti’s prescribing information (PDF) under the Warnings and Precautions section. The new warning, titled “Pathological Gambling and Other Compulsive Behaviors” now indicates that:

“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.”

Otsuka Pharmaceuticals and Bristol-Myers Squibb currently face several hundred Abilify lawsuits being pursued on behalf of individuals who have experienced catastrophic gambling losses that arose after starting treatment with the drug.

The complaints allege that the drug maker has been aware of the Abilify gambling risks for years, yet withheld important warnings that may have allowed consumers, physicians and families to identify the drug as the cause of compulsive behaviors before users experienced financial ruin.

Questions are now emerging about why Otsuka Pharmaceutical did not issue similar warnings about the potential gambling side effects with Rexulti earlier, and whether it was part of a misleading effort to portray the newer drug as a safer alternative, avoiding loss of Abilify sales following approval of generic equivalents.

As a result, the drug maker may face a new wave of Rexult gambling lawsuits, as the first Abilify bellwether trials are set to begin this summer.


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