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.
Funding for this initiative was made possible through a contract from the FDA (Contract#: 75F40119D10031). 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
Co-Investigator:
Jeffrey Brent, MD, PhD, DFACMT
University of Colorado School of Medicine
Aurora, CO
Co-Investigator:
Paul Wax, MD, DFACMT
Project Site Location Map
2024
1. Schimmel J, Epperson L, Aldy K, Wax P, Brent J, Bucahnan J, Levine M, Burkhart K; On behalf of the ToxIC FACT Study Group. Remdesivir discontinuation decisions based on thresholds of aminotransferase in an observational registry. Drugs. 2024;84(2):209-217. View Publication
2023
6. Devgun JM, Zhang R, Brent J, Wax P, Burkhart K, Meyn A, Campleman S, Abston S, Aldy K; On behalf of the ToxIC FACT Study Group. Identification of bradycardia following remdesivir administration through the US Food and Drug Administration American College of Medical Toxicology COVID-19 Toxic Pharmacovigilance Project. JAMA Netw Open. 2023;6(2):e2255815. View Publication
2022
1. Farah R, Kazzi Z, Brent J, Burkhart K, Wax P, Aldy K; On behalf of the ToxIC FACT Study Group. Ivermectin associated adverse events in the treatment and prevention of COVID-19 reported to the FACT pharmacovigilance project. Clin Toxicol (Phila). 2022;60(8):942-946. View Publication
2023
1. Levine M, Pizon AF, Boyle K, Schwarz E, Sharma K, Carey J, Amirshahi M, Hendrickson R, Olives T, Heard K, Brent J, Lavonas E, Wax P, Devgun J, Kazzi Z, Chary M, Schimmel J, Spyres M, Aldy K, Wiegand T, Marlin M, Shiekh S, Rianprakaisang T; On behalf of the ToxIC FACT Study Group. Adverse drug events associated with remdesivir among Hispanic populations. J Med Toxicol. 2023;19(2):142-143. View Abstract
2. Schimmel J, Epperson LC, Aldy K, Wax P, Brent J, Buchanan J, Levine M; On behalf of the ToxIC FACT Study Group. Remdesivir discontinuation based on thresholds of transaminase elevation in an observational registry. J Med Toxicol. 2023;19(2):139. View Abstract
3. Simon M, Pepin L, Buchanan J, Brent J, Wax P, Aldy K; On behalf of the ToxIC FACT Study Group. Adverse events in pediatric patients treated with COVID-19 therapeutics reported to the FDA ACMT COVID-19 ToxIC (FACT) Pharmacovigilance Project. J Med Toxicol. 2023;19(2):143-144. View Abstract
2022
1. Farah R, Kazzi Z, Brent J, Burkhart K, Wax P, Aldy K; On behalf of the ToxIC FACT Study Group. Ivermectin associated adverse events in the treatment and prophylaxis of COVID-19 reported to the FDA ACMT COVID-19 ToxIC (FACT) Pharmacovigilance Project Study Group. J Med Toxicol. 2022;18:79. View Abstract
2. Olives T, Hendrickson A, Meyn A, Campleman S, Abston S, Wax P, Brent J, Aldy K; On behalf of the ToxIC FACT Study Group. Burden of adverse events related to the treatment of COVID19 by race/ethnicity. J Med Toxicol. 2022;18:82. View Abstract
3. Simon M, Buchanan J, Brent J, Wax P, Burkhart K, Aldy K; On behalf of the ToxIC FACT Study Group. Pregnancy associated adverse events in patients treated with therapies for COVID-19 reported to the FDA ACMT COVID-19 ToxIC (FACT) Pharmacovigilance Project. Clin Toxicol (Phila). 2022;60(S2):18. View Abstract
2021
1. Aldy K, Wax P, Brent J, Marshall S, Campleman S, Abston S, Meyn A, Diak IL, Konkel K, Mundkur M, Dang O, Burkhart K; On behalf of the ToxIC FACT Study Group. Rapid development of the FDA ACMT COVID-19 ToxIC (FACT) Pharmacovigilance pilot project to monitor adverse events reported in association with COVID-19 therapeutics. Clin Toxicol (Phila). 2021;59(11):1054. View Abstract
2. Carey JL, Boyle KL, Aldy K, Campleman S, Abston S, Meyn A, Wax P, Brent J; On behalf of the ToxIC FACT Study Group. Adverse drug events associated with monoclonal antibodies used in the treatment of COVID-19. Clin Toxicol (Phila). 2021;59(11):1053-1054. View Abstract
3. Devgun J, Aldy K, Campleman S, Abston S, Meyn A, Brent J, Wax P; On behalf of the ToxIC FACT Study Group. Remdesivir associated bradycardia identified through the FDA ACMT COVID-19 ToxIC (FACT) Pharmacovigilance Project. Clin Toxicol (Phila). 2021; 59(11):1052. View Abstract
4. Wax PM, Aldy K, Brent J; On behalf of the ToxIC FACT Study Group. Rapid development of the FDA ACMT COVID-19 ToxIC (FACT) Pharmacovigilance pilot project to monitor adverse events reported in association with COVID-19 therapeutics. Toxicol Lett. 2021;350:S20. View Abstract