title: How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study.
abstract: First-in-class drugs use a unique mechanism of action. This study assessed the therapeutic innovativeness and safety of these drugs approved by Health Canada from 1997-2012.
  
  
  
  A list of new drugs was compiled and a database from the Food and Drug Administration was used to determine first-in-class status. Post-market safety warnings and drugs withdrawn for safety reasons were identified from the MedEffect Canada website. Therapeutic innovation evaluations came from the Patented Medicine Prices Review Board (PMPRB) and Prescrire International. The proportion of first-in-class drugs that were innovative was compared to the proportion of non-first-in-class drugs that were innovative. Kaplan-Meier survival curves assessed safety.
  
  
  
  In all, 462 drugs were approved by Health Canada during the period under study. Among these, 345 were evaluated by PMPRB and/or Prescrire, and first-in-class data were available for 292. Ninety-eight of the 292 were first-in-class and 16 were innovative compared to 9 of 194 drugs that were not-first-in-class. There was no difference in safety between the two groups.
  
  
  
  Overall, the benefit-to-harm ratio of first-in-class drugs, as measured by post-market safety warnings/withdrawals, is better than those that were not-first-in-class.
authors.affiliation: Professor Emeritus, School of Health Policy and Management, York University, Emergency Physician, University Health Network, Associate Professor, Department of Family and Community Medicine, University of Toronto, Toronto, ON.
authors.forename: Joel
authors.initials: J
authors.lastname: Lexchin
mesh_terms: D002170:Canada; D015331:Cohort Studies; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004341:Drug Evaluation / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D006801:Humans; D055553:Prescription Drugs / Q000145:classification* / Q000592:standards*; D014481:United States
chemical_list: D055553:Prescription Drugs