At the International Association of Parkinsonism and Related Disorders (IAPRD) conference in August 2018, Professor Weintraub discusses we should worry that pimavanserin might increase mortality amongst patients with Parkinson’s disease and psychosis.
1. In your opinion, do the FDA Adverse Event Reporting System (FAERS) data show a clear cause–effect relationship between pimavanserin and increased mortality? (0:12)
2. Do you feel that there was sufficient and robust clinical data supporting the efficacy and safety of pimavanserin in Parkinson's patients with psychosis prior to FDA approval? (0:44)
3. Does the potential increase in mortality outweigh clinical benefits such as improvement in visual hallucinations, paranoia and other psychotic symptoms? (1:25)
4. What alternatives are there for Parkinson's patients with dementia, given that all antipsychotics carry the same FDA black-box warning as pimavanserin for increased mortality in elderly patients with dementia? (2:22)
5. How do you respond to the FDA statement that it has not, at this time, identified a specific safety issue that is not already adequately described in the product labelling? (4:05)
Speaker disclosure: Daniel Weintraub has received funding or support from the Michael J. Fox Foundation for Parkinson’s Research, National Institutes of Health (NINDS), Department of Veteran’s Affairs, Alzheimer’s Therapeutic Research Initiative, Alzheimer’s Disease Co-Operative Study, and the International Parkinson’s and Movement Disorder Society. He has also received honoraria for consultancy from ACADIA Pharmaceuticals Inc., Alkahest, Anavex Life Sciences, Blackthorn Therapeutics, Bracket, Clintrex LLC, Sunovion, Theravance Biopharma, and the CHDI Foundation, license fee payments from the University of Pennsylvania for the QUIP and QUIP-RS, royalties from Wolters Kluwer, and fees for legal consultation for three lawsuits related to medication prescribing in patients with Parkinson’s disease.
Filmed at the XXII World Congress on Parkinson's Diseases and Related Disorders (IAPRD), Lyon, France, August 2018.