Nuplazid Produced Worsening Conditions for Many Users

Anti-psychotic drug Nuplazid (pimavanserin) is manufactured by Acadia pharmaceuticals and approved by the Federal Drug Administration (FDA) for treating Parkinson’s disease patients with debilitating psychosis.

The process of approval used for Nuplazid allowed an expedited pharmaceutical safety review by categorizing this drug as a breakthrough therapy.

Instituted by Congress in 2012, this breakthrough therapy classification was intended to expedite the FDA’s approval process for drugs that, based on evidence, could substantially improve the conditions of patients with serious or life-threatening conditions as compared to existing treatments available on the market. Representatives of the FDA consisting of an advisory committee make the determination if a drug’s possible benefits overshadow its potential risks.

Nuplazid and Parkinson’s Disease

Parkinson’s disease is a neurological disorder that that involves the damage to or death of dopamine producing brain cells. About half of all Parkinson’s patients experience delusions or hallucinations – this condition is known as Parkinson’s Disease Psychosis (PDP). The condition causes the patient to see or hear things that are not real. These patients can also develop beliefs that are untrue and separate from reality.

Nuplazid is a selective serotonin inverse agonist drug that functions by blocking Parkinson’s patients’ 5-HT2A serotonin receptors, possible contributors to PDP.

Even though the expedited process used for this drug required a demonstration of its benefits outweighing its risks, certain cases involving the adverse effects of Nuplazid have shown that the drug at times did not reduce PD psychosis but actually increased hallucinations.

Deaths Resulting From Nuplazid Use

Per statistics from the Institute for Safe Medicine Practices, as of the 12-month period concluding in March 2017, the use of Nuplazid resulted in 244 deaths. By the end of 2017, the FDA had reports of 712 deaths connected with the use of Nuplazid.

The current FDA black box warning for Nuplazid includes an advisory about the elevated risk of death in patients who have non-Parkinson’s dementia related psychosis. However, it does not provide a warning about the fatal risks to Parkinson’s patients.

Nuplazid litigation

Nuplazid drug attorneys involved with lawsuits regarding Nuplazid may allege that the drug’s manufacturer, Acadia Pharmaceuticals, Inc.:

• Manufactured and advertised an excessively dangerous drug
• Made Nuplazid available to the marketplace knowing of the severe side effects it can produce, including the increased possibility of death
• Failed to sufficiently warn the public and physicians concerning serious risks connected with the use of Nuplazid
• Continued to manufacture and advertise Nuplazid after becoming aware of adverse event reports involving numerous deaths associated with its use

If you have suffered a serious injury or if a loved one has been hurt or suffered death after using Nuplazid, you have the right to seek justice and compensation for your losses. Our experienced attorneys at McGowan, Hood, Felder & Phillips, LLC, are highly capable of evaluating your case and hold the responsible parties liable, including the manufacturer and/or medical providers. To schedule a free, initial consultation about your case, call our law office today at 803-327-7800 or send us a message through our contact form.