Parkinson’s Medication linked to More than 700 Deaths
By Sandra Dalton, Staff Writer
According to the U.S. Food and Drug Administration (FDA), as many as half of all Parkinson’s patients can experience hallucinations or delusions at some point during their illness. In April 2016, the FDA approved Nuplazid (pimavanserin) to treat hallucinations and delusions associated with psychosis in Parkinson’s patients. It is the first and so far, the only drug approved for this purpose. Unfortunately, it has been linked to serious adverse events including over 700 deaths. To make matters worse, many question whether the drug even works.
Less than two years after Nuplazid hit the market, the FDA’s Adverse Events Reporting System (FAERS) had received 5,735 adverse event reports linked to the drug. 712 were death reports. Adverse events and side effects associated with Nuplazid use include:
- Delusional thinking
- Increased hallucinations
Rushed Approval Process
The FDA granted Nuplazid breakthrough therapy designation, which is a program meant to speed up development and review of drugs that provide substantial improvement over existing treatment options. It also granted a priority review, which is expedited review which is supposed to be reserved for “drugs that offer a significant improvement in the safety or effectiveness for the treatment, prevention, or diagnosis of a serious condition.”
However, both the safety and effectiveness of Nuplazid were already in question when it was approved. The lead physician on the FDA medical review committee, Dr. Paul Andreason, warned the agency that in clinical trials those taking Nuplazid experienced serious problems including death at twice the rate of those taking a placebo. And while the brief and small study the FDA based approval on found the drug effective, prior studies did not.
Putting Profits Over Lives
When Nuplazid hit the market in June 2016, it was the only drug approved to treat hallucinations and delusional thinking in Parkinson’s patients, giving hope to those who wanted to bring loved ones back from the heart wrenching blackhole that those aspects of Parkinson’s disease can be. While doctors re allowed to prescribe drugs off-label when they believe they will help patients, insurance companies don’t always pay for off-label medications.
In 2017, Nuplazid sales reached about $125 million. According to a CNN report, Nuplazid maker Acadia Pharmaceuticals expects sales to be double or more in 2018.
If you believe that you have been harmed by Nuplazid or that the drug contributed to your loved one’s death, you can learn more about your rights and how you can recover damages for your losses by searching our directory to find a lawyer near you.