Black Box Warnings A to Z Emory S. Martin III, PharmD BCPS Vice President, Pharmacy Services 1 Scott & White Healthcare Objectives Following the presentation, the participant will: •  Be able to quantify the typical frequency of prescribing drugs that have a black box warning (BBW) •  Be able to list the common categories of prescribing practices in violation of BBWs •  Be able to navigate and use the FDA’s on-line tool for communicating new drug safety information •  Be able to identify 10 significant BBW drugs and how to avoid the BBWs 2 INTRODUCTION 3 What is a BBW? 4 BBW – More than a Precaution; Less than a Contraindication US FDA Labeling Cautions •  Precaution: Consideration must be taken in special situations/patient groups •  Warning: Serious adverse events that have been observed and potential safety hazards –  A “Black Box Warning” or “Boxed Warning” is the strongest warning the FDA issues •  Contraindication: Drug should not be used in a specific situation because risk much greater than possible benefit 5 BBW Used in 3 Situations •  There is an adverse reaction so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drug. •  There is a serious adverse reaction that can be prevented or reduced in frequency or severity by appropriate use of the drug (patient selection, monitoring, avoiding interactions, etc.) •  The drug can be safely used ONLY with certain use restrictions. h ttp://www.fda.gov/downloads/drugs/.../Guidances/ucm075096.pdf 6 Certain BBWs Are Linked to “REMS” •  An FDA mandate for post-marketing safety requirements 7 BBW – First Billing in the PDR 8 BBW – First Billing Under Warnings in Lexicomp 9 BBWs IN PATIENT CARE 10