Quick FDA Approval of Controversial Dementia Medication Brexpiprazole Stirs Debate Due to Increased Risk of Death.
Brexpiprazole Wrongful Death Lawsuit Lawyers
The U.S. Food and Drug Administration’s (FDA) speedy endorsement of brexpiprazole, an antipsychotic medication marketed as Rexulti, for treating agitation in dementia patients, has sparked widespread concern. This is particularly notable because clinical trials indicated that the medication not only lacks substantial benefits but also significantly elevates the risk of death.
The fast-tracking of medications is an option available to the FDA at the request of pharmaceutical companies. This accelerated approval mechanism aims to hasten the development and evaluation of drugs for grave conditions like Alzheimer’s disease, especially if they fulfill a previously unaddressed medical need.
To win FDA approval, the drug’s manufacturers, in this case, Otsuka Pharmaceutical Company, Ltd. and Lundbeck Inc., must convincingly demonstrate that the medication is both safe and effective. The stipulation is that the medication’s advantages should outweigh its known hazards.
Investigative reporting by Robert Whitaker in The BMJ has called into question the haste with which brexpiprazole received its approval, specifically raising concerns about the clinical evidence supporting its safety and effectiveness.
Questionable Clinical Trials
The Cohen-Mansfield Agitation Inventory (CMAI) serves as the standard evaluation tool for medications aiming to alleviate agitation in Alzheimer’s patients. Caregivers assess patients based on a range of behaviors, assigning scores that are then totalized. Research in 2021 posited that a clinically significant improvement would require a 17-point reduction in the CMAI score after 12 weeks of treatment.
The first two clinical studies of brexpiprazole did not win over the FDA, despite the second showing statistically significant but clinically unimpressive outcomes. A third study revealed only a 5.3-point reduction on the CMAI scale, falling short of the 17-point benchmark. Yet, the FDA’s public announcement in May 2023 claimed the drug resulted in “statistically significant and clinically meaningful improvements.”
Whitaker highlights inconsistencies in these clinical results. Specifically, the modest improvement was largely based on data from non-U.S. locations, as the drug showed no advantages in U.S.-based trials. This leads to a troubling question: Why did the FDA approve the drug based on such unconvincing data?
Heightened Mortality Risks
Over a 16-week trial period, the drug increased the death rate fourfold compared to a placebo. Although the FDA issued a ‘boxed warning’ to indicate this risk, the decision to approve the medication was not altered. Additional safety issues, such as the occurrence of urinary tract infections, insomnia, drowsiness, and cardiovascular incidents, were also flagged.
Nina Zeldes, a researcher at the consumer advocacy group Public Citizen, criticized the FDA’s decision, stating that the modest benefits do not justify the significant safety risks. Like other antipsychotics, this drug may lead to fatal outcomes without delivering a substantial benefit.
The accelerated approval could create an unfounded perception that brexpiprazole is more effective than other antipsychotics— a misconception that is not supported by comparative studies involving patients with Alzheimer’s disease.
Divergent Views within the FDA Advisory Committee
In a meeting held in April 2023, nine out of 10 FDA Advisory Committee members concluded that the drug’s advantages outweighed its disadvantages, even as some committee members voiced reservations about its use in cases with mild symptoms.
Professor Jess Fiedorowicz of the University of Ottawa, who voted in favor of approval, acknowledged that “the risk-benefit equation can be complex and context-dependent.” Meanwhile, some patient advocacy organizations also backed the medication, although Whitaker alleges that some of this support might be motivated by commercial interests.
Economic Factors and Compatibility with Existing Guidelines
With the cost of Rexulti hovering around $1,400 per month and projected annual sales reaching $1 billion, the commercial motives underlying its approval are hard to ignore.
Moreover, the FDA’s endorsement seems to contradict current best practices, which favor non-pharmaceutical interventions. In fact, existing guidelines from the American Psychiatric Association recommend starting with non-drug treatments.
Ongoing Debates and Future Implications
The approval raises questions about the marketing tactics that will be employed and how clinicians will respond based on their perceptions of antipsychotic treatments for dementia patients.
Although FDA Advisory Committee Chair Rajesh Narendran declined to comment on the matter, the ongoing debate indicates that the long-term consequences of the FDA’s decision remain uncertain.
Can the Family of the Decedent Harmed By Brexpiprazole File a Wrongful Death Lawsuit?
Generally speaking, if a person has died due to the alleged negligence or wrongdoing of another individual, company, or entity, the family of the deceased may have the legal right to file a wrongful death lawsuit. In the context of brexpiprazole or any other drug approved by the FDA, families might be able to file such a lawsuit if they believe that the drug caused the death of their loved one and that the pharmaceutical companies failed to adequately warn about the drug’s risks, were negligent in its production, or that there was some form of misconduct involved.
Here are some factors that might be considered in a potential wrongful death lawsuit involving a medication like brexpiprazole:
- Inadequate Warnings: Did the manufacturer provide sufficient warnings about the potential risks of the drug? Were these warnings adequately conveyed to both the medical community and the patients?
- Misrepresentation: Were any claims made about the drug that could be considered false or misleading?
- FDA Approval: Although FDA approval can sometimes offer a form of defense for pharmaceutical companies, it doesn’t necessarily protect them from all legal action, particularly if new information comes to light.
- Causation: It would generally need to be proven that the drug was the direct cause of the individual’s death, a task often complicated by the individual’s overall health condition and any other medications they may have been taking.
- Economic and Non-Economic Damages: Compensation could be sought for both economic damages (like funeral expenses or loss of income to the family) and non-economic damages (like pain and suffering).
- State Laws: Wrongful death laws can vary by state, so local laws will dictate who can file a claim, what types of damages can be recovered, and within what time frame.
If you believe that you have a case for a wrongful death lawsuit, it’s crucial to consult with one of our attorneys who handle these types of cases. Our legal professionals can provide advice tailored to the specifics of your situation and guide you through the complex legal process.
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