Michael Fralick, MD, FRCPC, SM, PhD (Cand) Clinical Associate, General Internal Medicine, St Michael’s Hospital Phillipson Scholar, Clinician Scientist Program, University of Toronto  PhD Candidate, IHPME, University of Toronto Affiliated Faculty, Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s Hospital, Harvard University

NUEDEXTA® (Dextromethorphan and Quinidine) Studied for ALS and MS but Primarily Use in Dementia

MedicalResearch.com Interview with:

Michael Fralick, MD, FRCPC, SM, PhD (Cand) Clinical Associate, General Internal Medicine, St Michael’s Hospital Phillipson Scholar, Clinician Scientist Program, University of Toronto  PhD Candidate, IHPME, University of Toronto Affiliated Faculty, Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s Hospital, Harvard University

Dr. Fralick

Michael Fralick, MD, FRCPC, SM, PhD (Cand)
Clinical Associate, General Internal Medicine
St Michael’s Hospital
Phillipson Scholar, Clinician Scientist Program, University of Toronto
PhD Candidate, IHPME, University of Toronto
Affiliated Faculty, Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham and Women’s Hospital, Harvard University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This medication is a pill that combines two ingredients: dextromethorphan (the active ingredient in cough syrup) and quinidine (used to increase the concentration of dextromethorphan). The medication was primarily studied and evaluated in patients with amyotrophic lateral sclerosis (ALS)   or (multiple sclerosis) MS, but anecdotal evidence suggested it was being prescribed to patients with dementia. We used data from two nationwide healthcare databases to understand how the medication was being used in routine care.

MedicalResearch.com: What should readers take away from your report?

Response: Our study identified that this medication is primarily prescribed to patients with dementia or Parkinson’s disease. This is concerning, since very few studies have evaluated the effectiveness or safety in this patient population. Furthermore, adults with dementia are a vulnerable population and this medication is associated with a number of important side-effect. 

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: Future studies are required to understand the safety of this medication in routine care and also to understand how it is being prescribed in adults over the age of 65.

MedicalResearch.com: Is there anything else you would like to add? 

Response: It is important that physicians realize this medication was primarily studied in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). There are very little data to support its use in patients who do not have either condition. The medication is associated with significant side effects including falls, urinary tract infection, and confusion. 

Citation:

Fralick M, Sacks CA, Kesselheim AS. Assessment of Use of Combined Dextromethorphan and Quinidine in Patients With Dementia or Parkinson Disease After US Food and Drug Administration Approval for Pseudobulbar Affect. JAMA Intern Med. Published online January 07, 2019. doi:10.1001/jamainternmed.2018.6112

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Last Updated on January 8, 2019 by Marie Benz MD FAAD