QuarterWatch™ Reports October 2013

Leading Drug Safety Issues of 2012

In this QuarterWatch™ report we examine the leading drug safety problems reported to the US Food and Drug Administration (FDA) for the calendar year 2012. Our ranking of the year’s major issues in drug safety comes from four different perspectives on tens of thousands of serious and fatal adverse drug events.

  1. Reports that consumers and health professionals submitted directly to the FDA identified two anticoagulants, dabigatran (PRADAXA) and warfarin (COUMADIN), as the most frequent suspect drugs for the year.
  2. Cases from drug manufacturers about new, serious adverse events without adequate current warnings in the prescribing information flagged three anti-tumor necrosis factor (anti-TNF) products, etanercept (ENBREL), adalimumab (HUMIRA), and infliximab (REMICADE).
  3. The potent synthetic opioid fentanyl (DURAGESIC) in patch form was prominent in two different kinds of drug safety issues, product quality complaints and reported medication errors.
  4. Lower limb fractures and other bone disorders associated with alendronate (FOSAMAX) for osteoporosis were key results from our statistical tests to link suspect drugs with specific side effects.

In 2012, the FDA received a total of 210,648 domestic reports of serious, disabling, or fatal adverse events associated with therapeutic drugs, an increase of 16% from the previous year. Reports that consumers and health professionals made directly to the FDA declined from 21,000 to 20,310 (-3.3%) while reports originated by manufacturers increased by 18.5%, from 160,598 to 190,338.


QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP). We analyze computer excerpts from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). These reports (best known as MedWatch reports) are a cornerstone of the nation’s system for monitoring the safety of prescription drugs after FDA marketing approval.