Unsafe Drugs Were Prescribed More Than One Hundred Million Times in the United States Before Being Recalled

Int J Health Serv. 2016 Jul;46(3):523-30. doi: 10.1177/0020731416654662. Epub 2016 Jun 14.


For some drugs, safety concerns are only discovered after they have been on the market, sometimes for several years. The U.S. Food and Drug Administration (FDA) has adopted several policies that could increase the likelihood of approving a potentially unsafe medication. We attempted to quantify the number of exposures in the United States to drugs that were newly approved but later withdrawn from the market. We obtained a list of all drugs approved and subsequently withdrawn from the U.S. market due to safety concerns between 1993 and 2010. Using a representative sample of outpatient physician office visits in the National Ambulatory Medical Care Survey, we estimated the number of visits in the United States at which these unsafe drugs were prescribed. Seventeen drugs were approved and later withdrawn during this 18-year period and were prescribed at 112 million physician office visits in the United States. Nine of these drugs were prescribed more than 1 million times before their market withdrawal. New drugs that are later withdrawn due to being unsafe are frequently prescribed in the United States. To minimize the negative health consequences of prescribing potentially unsafe medications, we should reconsider some of the FDA policies that encourage the rapid approval and dissemination of new drugs.

Keywords: United States food and drug administration; drug industry; pharmacoepidemiology; safety-based drug withdrawals.

MeSH terms

  • Ambulatory Care
  • Drug Utilization
  • Health Surveys / statistics & numerical data*
  • Humans
  • Office Visits / statistics & numerical data
  • Practice Patterns, Physicians' / statistics & numerical data*
  • Safety-Based Drug Withdrawals*
  • United States
  • United States Food and Drug Administration