FDA: Patients Using Rexulti At Risk For Experiencing Intense Urges For Gambling And Inability To Control Conduct
Rexulti® (brexpiprazole) was initially approved by the FDA in 2015 for the adjunctive treatment of major depressive disorder (MDD) and the treatment of schizophrenia.
As shown in a February 9, 2018 FDA letter to Otsuka Pharmaceutical Company, Ltd., the agency approved some label changes for Rexulti for the addition of warnings about pathological gambling and other compulsive behaviors:
Please refer to your Supplemental New Drug Application (sNDA) dated and received June 23, 2017....
This Prior Approval supplemental new drug application provides for a new subsection under the Warnings and Precautions section entitled Pathological Gambling and Other Compulsive Behaviors and corollary revisions to the Highlights, Adverse Reactions, Patient Counseling Information, and Medication Guide.
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And from the FULL PRESCRIBING INFORMATION Revised: 02/2018 document for Rexulti (accessed 5/22/18) we get the text of what was added to the Warnings and Precautions section:
5.7 Pathological Gambling and Other Compulsive Behaviors
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 drug companies responsible for Rexulti in the US are Otsuka Pharmaceutical Co., Ltd. (Japan), Otsuka America Pharmaceutical, Inc. (Maryland), and Lundbeck (Illinois).
Our law firm is investigating possible products liability lawsuits against those companies for people who have experienced compulsive gambling behaviors while using Rexulti. Those cases would involve one or more of the following consequences: personal debt; bankruptcy; home foreclosure; divorce; unemployment; emotional trauma; and, damaged reputation.
If we can be of assistance to you or a loved one as regards a possible Rexulti drug injury legal compensation case, please do not hesitate to contact us.
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