Adverse Drug Events

An Adverse Drug Event (ADE) is an illness resulting from the administration of a drug. An ADE could be because of an interaction with another drug, improper dosing, or because of a genetic variant in the way that an individual metabolizes a particular medication.

PGx Testing and FDA Labeling

The Food and Drug Administration has been providing guidance to drug companies to promote PGx testing to shorten development times and introduce new therapies. Product labeling has been adjusted to include genetic information to aid in dosage information of the drug.

Hundreds of common medications now offer recommendations on avoidance of ADEs when products are being prescribed.

Incidence of Adverse Drug Events (ADEs)

∗ 128,000 deaths in the US are directly attributable to ADEs, ranking as one of the top five causes of death in the US each year. Harvard University Safra Center for Ethics, 6/27/14

∗ ADEs are responsible for over 3.5 million outpatient visits each year, and more than 700,000 ER visits. Office of Disease Prevention and Health Promotion

∗ One third of all new drugs approved between 2001 and 2010 had major safety issues after being made publicly available; as reported in JAMA, Yale researchers discovered 71 of 222 drugs were withdrawn, required a black box warning, or warranted a safety warning about risks.