Nuplazid, the first and only drug indicated to treat hallucinations and delusions associated with Parkinson’s disease psychosis, has been linked to thousands of adverse events, including as many as 700 deaths.
Because it was considered a “Breakthrough Therapy” by the U.S. Food & Drug Administration (FDA), Nuplazid wasn’t subjected to the extensive testing usually required of most new prescription drugs. Now, rising Nuplazid side effect reports have many concerned that the drug was unduly rushed to market and that its risks do not outweigh its purported benefits.
You may be entitled to significant compensation if you or someone you love took Nuplazid and suffered serious or even deadly complications potentially associated with its use.
The attorneys at Gilman Law LLP are committed to ensuring that the victims of dangerous drug side effects obtain the justice they deserve. Filing a Nuplazid lawsuit may be the only way for you and your family to hold Acadia Pharmaceuticals accountable and recover compensation for the medical bills and other damages related to your injuries.
CONTACT US NOW! Any Delay May Result in A Complete Bar to Your Nuplazid Lawsuit Regardless of Its Merit!
Nuplazid FDA Approval
Nuplazid was brought to market in April 2016 under a process that allows a new drug review to be expedited if a medication has been designated a “Breakthrough Therapy.” This designation is only permitted for therapies that have demonstrated “substantial improvement” in patients with serious or life-threatening diseases when compared to treatments already available on the market.
Nuplazid was approved on the basis of a single 6-week trial that involved around 200 patients. During the trial, patients treated with Nuplazid were twice as likely to die or suffer serious complications compared to those taking a placebo.
While an FDA advisory panel ultimately recommended that Nuplazid be approved by a vote of 12-2, some of the panel members who favored its approval expressed reservations about the deaths and adverse events seen in its single positive clinical trial.
CNN Details Nuplazid Deaths and Adverse Event Reports
According to an investigative report that recently aired on CNN, patients, their family members, and doctors began reporting possible Nuplazid side effects to the FDA’s adverse event database shortly after the drug was approved in April 2016.
In November 2017, the non-profit Institute for Safe Medication Practices (ISMP) reported that more than 2,200 adverse events related to Nuplazid had been logged with the FDA during the 12-months ending March 2017. These reports included 244 deaths, as well as more than 487 instances in which patients continued to experience hallucinations after they began taking Nuplazid.
Nuplazid adverse event reports continued to rise after the ISMP released its analysis. By the time CNN aired its investigation, the agency had received 500 reports of Nuplazid deaths and more than 1,000 reports of its ineffectiveness. Other adverse events related to Nuplazid included life-threatening incidents, falls, insomnia, nausea and fatigue.
Legal Help for Victims of Nuplazid Side Effects
The attorneys at Gilman Law LLP are available now to provide free legal consultations to the victims of Nuplazid side effects.
For a free, no-obligation review of your potential Nuplazid lawsuit, please fill out our free consultation form or call us direct to speak with one of our attorneys at (888) 252-0048.