The U.S. Food and Drug Administration (FDA) is reexamining the safety of Nuplazid, a drug that was approved in spite of concerns that not enough was known about its risks. According to a CNN news report, the FDA is re-examining the medication, which is the only drug approved to treat hallucinations and delusions associated with Parkinson’s disease psychosis. The medication has been cited as a “suspect” is hundreds of deaths voluntarily reported by caregivers, doctors and other medical professionals since it hit the market.
FDA officials said the agency’s renewed evaluation of Nuplazid was based on a number of factors, but they are not saying what those factors are. Instead, officials would only say that they generally identify potential “signals of serious risk/new safety information” partially by using adverse event data and that the agency is not yet suggesting that physicians stop prescribing the drug or take patients off it while the evaluation is taking place.
Serious Adverse Events
The FDA has noted that fatality reports involving Nuplazid have typically involved elderly patients who have advanced-stage Parkinson’s disease who suffered from several medical conditions. But physicians, researchers and other medical experts told CNN that the high number of adverse event reports warranted a closer look to determine if these deaths are in fact directly connected to the drug. Experts are also recommending further testing of Nuplazid because of concerns that the drug had been given the stamp of approval too quickly without sufficient evidence of its safety or efficacy.
The FDA has speeded up Nuplazid’s review because it had been presented as a “breakthrough therapy,” which means that patients who took it noticed a substantial improvement compared to therapies that are already out there. In fact, CNN reports that one of the physicians who led the FDA’s initial review of Nuplazid warned that patients who took the drug during the company’s clinical trials experienced serious outcomes including death at double the rate of those taking the placebo. However, the FDA determined that the benefits of the drug outweighed the risks. Some of the adverse events possibly linked to the drug included deaths, falls, insomnia, nausea and fatigue.
Drug manufacturers have the sacred responsibility to ensure that the medications they sell to patients are safe. These companies are required to put these drugs through a number of trials in order to determine not just if the drugs are effective, but also if they are safe. While most drugs, prescription or over-the-counter, have some type of side effect, it is important to remember that it is unacceptable for these side effects to result in catastrophic or fatal injuries. If you or a loved one has suffered adverse effects as a result of Nuplazid or some other dangerous or defective drugs, please contact an experienced product defect lawyer to obtain more information about pursuing your legal rights.