Wake Forest Translational Science Institute (TSI)

December 2011 Drug Safety e-Update

Table of Contents

Regulatory Reports

  • Avastin no longer approved by FDA for treatment of metastatic breast cancer
  • One of three FDA-sponsored studies finds no link between ADHD drugs and cardiovascular events in children and young adults
  • Listing of current drug shortages
  • FDA safety labeling changes for October, 2011
  • Accessing data from the FDA Adverse Event Reporting System

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Medical Literature Reports

  • Handful of commonly prescribed medications is responsible for majority of emergency hospital admissions among older adults
  • Polypharmacy linked to greater severity of erectile dysfunction in a dose-dependent manner
  • Suspected link between statins and cancer risk dispelled
  • Don’t dismiss FDA “potential safety signals,” even though the agency consistently makes no recommendations for changes in prescribing patterns

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Other Information

  • Thalidomide and the evolution of drug safety over the past fifty years
  • Frequently asked questions about Vitamin D
  • Clinical and pharmacologic description of “new molecular entity” drugs approved in 2010 and in 2011 

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Printable version of December 2011 Drug Safety e-Update