FDA ACMT COVID-19 ToxIC (FACT) Pharmacovigilance Project 

About the Project

The rapid spread of COVID-19 has posed an unprecedented challenge to healthcare providers and the public health community. The COVID-19 pandemic has an immense societal impact and has called for an all-out public health response. There is an urgent need for rapid data collection and dissemination of medical information associated with COVID-19 to the medical and public health community, including treatments to combat the disease.

Treatment for COVID-19 has included both the new use of established medications and the emergence of novel therapeutics. The advancing knowledge of COVID-19 mechanisms has led to a rapid pace of evolving treatment methods with very little prior scientific evidence or proven dosing regimens. The risk of increased adverse drug events (ADEs) is evident, and there is a need for enhanced monitoring.

Safety surveillance of adverse events specific for drugs and substances associated with the treatment of patients with COVID-19 is consistent with FDA’s mission of ensuring drug safety throughout the drug lifecycle. The FDA ACMT COVID-19 ToxIC (FACT) Pharmacovigilance Project Sub-registry provides a mechanism for enhanced collection of safety data related to drug therapies used in patients treated for COVID-19.

Administering Institutions: American College of Medical Toxicology

Project Contract ID: 75F40119D10031 FDA

Funding period: 2020-2021

Funding for this initiative was made possible (in part) by grant number 75F40119D10031 from FDA. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the FDA; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.

Principal Investigators

Dr. Jeffrey Brent

Jeffrey Brent, MD, FACMT
University of Colorado School of Medicine
Aurora, CO 

Paul Wax, MD, FACMT

Project Site Location Map