The US Food and Drug Administration (FDA) has decided to re-examine the safety of the drugs for the treatment of Parkinson’s disease, which were approved earlier in 2016.
Scott Gottlieb, FDA commissioner, has recently announced that they are rethinking about the approval of the new drug, as there are about hundreds of deaths reported which were associated with the new drug after its permission for use in the market. These reports have been provided by patient’s caregivers as well as medical health professionals voluntarily. The FDA has asserted that the investigation has been already started from last few weeks to find the causative association of deaths and the new drug.
Generally, if there is any safety concern related to any drug, the FDA studies the previous safety data provided by the drug-producing company. Depending on the study, the FDA might change the approval status of the drug; it may not be banned completely, but some changes like use restriction, label change, and the addition of the warnings to protect the users can be procured. In some cases, the drugs can be completely banned. Although the drug for Parkinson’s disease is still open for the use in the market, there are cases where miss events have been reported to the FDA. The agency is working on the safety evaluations, and has allowed the physicians for using the drug until the further decisions are announced.
Dr. Paul Andreason, head of the FDA medical panel for Nuplazid, notified that the patients’ deaths were more common while treating them with this drug, if it was compared with placebo. However, the FDA has asserted that the drug has benefitted the patients more than the risks. The families of the patients receiving this medicine also have reported the considerable improvement in the patient’s health.
Recently, Biodesign researchers at the Arizona State University-Banner Neurodegenerative Disease Research Center also have revealed a new study, which has opened new possibilities to improve the Parkinson’s disease treatment.
Sasha Farrell is a privileged and versatile content writer and editor in the domains of Pharma, Health, and Medical. Before getting into the writing world, Sasha was working as an STM editor for few renowned authors and publications, which gave head-start to rifle through the Pharma, Health, and Medical Innovations.