Updates on Safety Doubts Surrounding Nuplazid
In June of 2016, antipsychotic pharmaceutical drug Nuplazid was approved as a new method of treating psychosis in Parkinson’s patients. Since it’s release over two years ago, concern has arose regarding the drug, with some claiming it was released before more stringent testing could be completed and others concerned that the possible side effects of the medication outweigh the benefits. Here, the pharmaceutical liability attorneys at The Law Offices of Peter Angelos discuss updates on safety concerns surrounding Nuplazid.
Psychosis is Seen in Most-Advanced Stages of Parkinson’s
Parkinson’s-related psychosis, which affects roughly 50% of one million Americans suffering from the disease, haunts victims with hallucinations of humans, animals, dark figures and more, causing fear and emotional distress. For example, some patients can see cats or dogs in their home that do not exist or frightening and ghost-like shadows that seem to be stalking them. Due to the severe nature of psychosis in Parkinson’s Disease patients, Acadia Pharmaceuticals, located in California, began the development of an antipsychotic drug called Nuplazid, which would be the first pharmaceutical drug created to specifically treat Parkinson’s-related psychosis.
Brendan Tyne Advocates for Approval of Nuplazid by the FDA
During the development stages of Nuplazid, Brendan Tyne, a New Jersey resident, advocated for the release of Nuplazid on behalf of his mother, who suffered from Parkinson’s disease and Parkinson’s-related psychosis. Despite uncertainties surrounding the new drug, Tyne pushed for the Food and Drug Administration (FDA) to quickly release the drug to help his mother, who was haunted by hallucinations due to the rapidly-declining nature of her condition. In addition to the pleas of Tyne, Nuplazid’s review was expedited due to its labeling as a “breakthrough therapy” as a result of the alleged significant improvements seen in a variety of patients involved in a trial of the drug.
Developers of Nuplazid claimed that it was a new form of antipsychotic drug that targeted a different receptor of the brain than other drugs of a similar nature—this improved targeting purportedly came with less toxic side effects than other antipsychotic drugs. Nuplazid was soon released after these claims, despite concerns of the drug’s potential dangers, and as soon as Nuplazid hit the market in June of 2016, Tyne immediately obtained the drug in order to begin his mother’s treatment.
Nuplazid Might be Causing More Harm Than Good Due to Early Release
Between Nuplazid’s release in June of 2016 and March of 2017, 244 Nuplazid-related deaths were reported to the FDA. In addition, hundreds of reports claimed that the drug was not providing the declared benefits that were expected or that the drug actually worsened the condition of patients taking it to treat their psychosis. In Tyne’s case, Nuplazid did nothing to stop the decline of his mother’s condition. Since the Institute for Safe Medical Practices released an analysis of the adverse event data concerning Nuplazid, the number of reported deaths of patients taking the drug has increased to 700.
Nuplazid Side Effects and Outcomes Remain Ambiguous
Since these worrying numbers of Nuplazid-related deaths have been released, the drug’s effectiveness has been called into question. Many are concerned that the drug was released too early and needed to be analyzed more before being released to the public. Others believe that the concerning number of deaths of patients being treated with Nuplazid is moreso related to the devastating nature of Parkinson’s disease itself rather than the drug’s side effects. Meanwhile, Acadia Pharmaceuticals is continuing to conduct clinical trials using Nuplazid as a means to have the medication approved to a larger patient pool, such as those suffering with dementia and other neurological conditions. As a result of the current results and unanswered questions, a growing number of health professionals and organizations are growing apprehensive of the drug’s validity and effectiveness as a method of psychosis treatment.
The Attorneys at The Law Offices of Peter Angelos Offer Legal Counsel to Victims’ Families
While many individuals suffering from a physical or mental condition experience benefits from pharmaceutical drugs, many others can become victim to adverse drug reactions and understated side effects. While it remains uncertain whether the antipsychotic drug Nuplazid unequivocally causes death in patients with Parkinson’s disease, the rising number of deaths and those who experience no benefits remains unsettling. If you have a loved one who is suffering from Parkinson’s-related psychosis who is experiencing no improvement on the drug Nuplazid, or if you have lost a loved one after they began treatment with Nuplazid, contact the pharmaceutical liability attorneys at The Law Offices of Peter Angelos now.