title: Market withdrawal of new molecular entities approved in the United States from 1980 to 2009.
abstract: OBJECTIVE
  Economic factors, market dynamics, and safety issues are largely responsible for decisions to withdraw pharmaceutical products from the market. In this study, new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) were examined in the USA from 1980 to 2009.
  
  
  METHODS
  Data were obtained from the FDA, Micromedex, Medline, and Lexis-Nexis. Descriptive analyses were used to classify product discontinuations by therapeutic category, time frame for discontinuation, and reason for withdrawal.
  
  
  RESULTS
  There were 740 NMEs approved by the FDA during the study period. As of 1 December 2010, the number of drugs discontinued was 118 (15.9%). Discontinuations were the highest for antiparasitic products, insecticides, and repellents (6, 33.3% of approvals), systemic hormonal preparations excluding sex hormones and insulins (5, 33.3%), musculo-skeletal system (11, 32.4%), diagnostic agents (16, 28.1%), and anti-infectives for systemic use (27, 25.2%). Safety was the primary reason for withdrawing 26 drugs (3.5% of approvals).
  
  
  CONCLUSIONS
  Approximately one in seven approved NMEs were discontinued from the market in the period of 1980-2009. Less than one-quarter (22%) of the total withdrawals were attributed to safety reasons. An ongoing evaluation of new drugs throughout their product life cycle is important to determine their efficacy, safety, and value to society.
authors.affiliation: South Carolina Center of Economic Excellence for Medication Safety and Efficacy and the Southern Network on Adverse Reactions, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA.
authors.forename: Zaina P
authors.initials: ZP
authors.lastname: Qureshi
authors.forename: Enrique
authors.initials: E
authors.lastname: Seoane-Vazquez
authors.forename: Rosa
authors.initials: R
authors.lastname: Rodriguez-Monguio
authors.forename: Kurt B
authors.initials: KB
authors.lastname: Stevenson
authors.forename: Sheryl L
authors.initials: SL
authors.lastname: Szeinbach
mesh_terms: D003132:Commerce; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015195:Drug Design; D006801:Humans; D057051:Product Recalls and Withdrawals; D012106:Research; D056737:Safety-Based Drug Withdrawals / Q000706:statistics & numerical data*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration