title: How safe are new drugs? Market withdrawal of drugs approved in Canada between 1990 and 2009.
abstract: BACKGROUND
  Studying drugs withdrawn from the market for safety reasons can help in evaluating the strengths and weaknesses of the pre- and post-market safety evaluation systems. This study considered 2 questions: Has there been a change over time in the percentage of new drugs that are eventually withdrawn because of safety reasons? How long are new drugs on the market before their serious safety problems are recognized?
  
  
  METHODS
  All drugs approved between 1 January 1990 and 31 December 2009 and subsequently withdrawn for safety reasons (until 1 October 2013) were identified, and the generic name, date of approval, and date of withdrawal were recorded. The total number of drugs approved over the same period was obtained from annual Health Canada reports. The percentages of new active substances approved in the 5-year periods 1990-1994, 1995-1999, 2000-2004, and 2005-2009 and eventually withdrawn were compared using the χ(2) test. The time between approval and withdrawal was calculated in days.
  
  
  RESULTS
  Of the 528 new drugs approved over the period of interest, a total of 22 (4.2%) were eventually withdrawn. Between 3.9% and 4.4% of the drugs approved in each 5-year period were eventually withdrawn (χ(2) = 0.04, p = 0.99 for difference among 5-year periods). The median time between approval and withdrawal was 1271 days (interquartile range 706-2876).
  
  
  CONCLUSIONS
  One explanation for the finding of no difference in the percentage of drugs approved in the four 5-year periods that were eventually withdrawn is the lack of any change in the rigour of the premarket evaluation system and the postmarket surveillance systems. The 1271-day median time between Notice of Compliance and withdrawal emphasizes the need to be particularly cautious in prescribing new drugs early in their life cycle.
authors.affiliation: Joel Lexchin, MSc, MD, is a Professor in the School of Health Policy and Management at York University, a staff physician in the Emergency Department of the University Health Network, and an Associate Professor in the Department of Family and Community Medicine, University of Toronto, Toronto, Ontario.
authors.forename: Joel
authors.initials: J
authors.lastname: Lexchin
mesh_terms: D002170:Canada; D017277:Drug Approval / Q000706:statistics & numerical data*; D016903:Drug Monitoring; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000592:standards / Q000706:statistics & numerical data*; D056737:Safety-Based Drug Withdrawals / Q000706:statistics & numerical data*; D013997:Time Factors