Nuplazid (pimavanserin) is a new-generation Parkinson’s disease drug, introduced in April 2016. The U.S. Food and Drug Administration (FDA) has already received at least 5,735 adverse event reports including 712 deaths linked to Nuplazid in the short time that it has been on the market. The drug is made by Acadia Pharmaceuticals and is an atypical antipsychotic used to reduce hallucinations in Parkinson’s patients. In addition to the side effects and adverse event reports, Nuplazid’s efficacy has come into question.
Nuplazid Side Effects and Injuries
Side effects and adverse events linked to Nuplazid use include:
- Increased hallucinations
- Delusional thinking
- Swelling of legs, ankles and feet
Rushed to Market
Nuplazid was approved by the FDA in an expedited process as a “breakthrough therapy”. The program was created to get drugs developed and reviewed faster when preliminary evidence shows that they may provide substantial improvement over available therapies for serious conditions. Nuplazid also got a “priority review” meant to speed drugs to market that are believed to be a significant improvement in safety or effectiveness in preventing, diagnosing, or treating serious conditions.
Approved Based on One Short, Small Study
The FDA approved Nuplazid based on a very short and small clinical trial. The study lasted only six weeks study and only looked at 199 patients. The agency granted approval even though the lead physician on the agency’s medical review committee warned that in clinical trials patients taking Nuplazid experienced a twofold increase in side effects, over those taking a placebo and despite the fact that previous studies had not found the drug to be effective.
If you believe that your injuries or the death of a loved one was caused but Nuplazid, please talk to an experienced defective pharmaceutica attorney right away to learn more about your rights and potential compensation.