PMID- 37581858
OWN - NLM
STAT- MEDLINE
DCOM- 20230927
LR  - 20231003
IS  - 1937-6995 (Electronic)
IS  - 1556-9039 (Print)
IS  - 1556-9039 (Linking)
VI  - 19
IP  - 4
DP  - 2023 Oct
TI  - Adverse Events in Pregnant Patients Treated with Coronavirus Disease 2019 
      Therapeutics.
PG  - 381-388
LID - 10.1007/s13181-023-00961-3 [doi]
AB  - BACKGROUND: Pregnant patients are at high risk of maternal and fetal 
      complications from Coronavirus Disease 2019 (COVID-19) infections. The COVID-19 
      pandemic prompted a surge in the development and repurposing of therapies for the 
      SARS-CoV-2 virus. Evidence is sparse on the efficacy and safety of these 
      therapies in pregnant patients. Our objective was to describe adverse events 
      (AEs) to COVID-19 therapeutics in pregnant patients. METHODS: This was a case 
      series of AEs reported to the FDA ACMT COVID-19 ToxIC (FACT) Pharmacovigilance 
      Project between November 23, 2020, and June 28, 2022. FACT is an ongoing 
      toxicosurveillance project at 17 sites to proactively identify and report AEs 
      associated with COVID-19 therapeutics. Abstracted information includes 
      demographics, case narratives, exposure details, clinical information, pregnancy 
      details, treatments, and outcomes. RESULTS: Forty-six COVID-19-positive pregnant 
      patients who developed AEs following COVID-19 therapeutics were reported to the 
      FACT Pharmacovigilance Project over 19 months. The most reported medications were 
      remdesivir in 22 patients (47.8%) and casirivimab/imdevimab in 8 patients 
      (17.4%). Four patients (8.7%) had life-threatening clinical manifestation, and 16 
      patients (34.8%) required intervention to prevent permanent damage. The most 
      common maternal and fetal events were elevated serum alanine aminotransferase 
      (26.1%) and non-reassuring fetal heart patterns (20.0%), respectively. 
      CONCLUSIONS: This case series reports AEs of elevated serum alanine 
      aminotransferase, maternal bradycardia, maternal hypothermia, non-reassuring 
      fetal heart patterns, and emergent or unplanned cesarean sections following 
      administration of several COVID-19 therapeutics. This study was not designed to 
      definitely identify causation, and further study is needed to evaluate the causal 
      role of these therapeutics in AEs affecting pregnant COVID-19 patients.
CI  - (c) 2023. American College of Medical Toxicology.
FAU - Simon, Mark
AU  - Simon M
AUID- ORCID: 0000-0001-9686-9832
AD  - Rocky Mountain Poison & Drug Safety, Denver Health & Hospital Authority, 1391 
      Speer Blvd, Unit 600, Denver, CO, 80204, USA. mark.simon@denverem.org.
AD  - Department of Emergency Medicine, Denver Health Medical Center, Denver, CO, USA. 
      mark.simon@denverem.org.
FAU - Buchanan, Jennie
AU  - Buchanan J
AUID- ORCID: 0000-0001-9855-8915
AD  - Rocky Mountain Poison & Drug Safety, Denver Health & Hospital Authority, 1391 
      Speer Blvd, Unit 600, Denver, CO, 80204, USA.
AD  - Department of Emergency Medicine, Denver Health Medical Center, Denver, CO, USA.
FAU - Schimmel, Jonathan
AU  - Schimmel J
AUID- ORCID: 0000-0002-6383-8308
AD  - Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New 
      York, NY, USA.
FAU - Brent, Jeffrey
AU  - Brent J
AUID- ORCID: 0000-0003-3763-4755
AD  - School of Medicine, University of Colorado, CO, Aurora, USA.
FAU - Burkhart, Keith
AU  - Burkhart K
AUID- ORCID: 0000-0001-8107-4818
AD  - Center for Drug Evaluation and Research, United States Food and Drug 
      Administration, Silver Spring, MD, USA.
FAU - Wax, Paul
AU  - Wax P
AD  - American College of Medical Toxicology, Phoenix, AZ, USA.
AD  - University of Texas Southwestern Medical Center, Dallas, TX, USA.
FAU - Taylor, Natalie
AU  - Taylor N
AUID- ORCID: 0000-0003-2032-8436
AD  - Department of Obstetrics and Gynecology, University of Colorado, Aurora, CO, USA.
FAU - Aldy, Kim
AU  - Aldy K
AUID- ORCID: 0000-0002-3198-2321
AD  - American College of Medical Toxicology, Phoenix, AZ, USA.
CN  - Toxicology Investigators Consortium FACT Study Group
LA  - eng
GR  - Contract 75F40119D10031/7540120F19003/FD/FDA HHS/United States
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20230815
PL  - United States
TA  - J Med Toxicol
JT  - Journal of medical toxicology : official journal of the American College of 
      Medical Toxicology
JID - 101284598
RN  - EC 2.6.1.2 (Alanine Transaminase)
SB  - IM
MH  - Pregnancy
MH  - Female
MH  - Humans
MH  - *COVID-19
MH  - SARS-CoV-2
MH  - Pandemics
MH  - Alanine Transaminase
MH  - *Pregnancy Complications, Infectious/drug therapy
PMC - PMC10522537
OTO - NOTNLM
OT  - Adverse events
OT  - COVID-19
OT  - Pregnancy
OT  - Therapeutics
COIS- The authors declare no competing interests.
EDAT- 2023/08/15 12:42
MHDA- 2023/09/27 06:42
PMCR- 2024/10/01
CRDT- 2023/08/15 11:10
PHST- 2023/06/21 00:00 [received]
PHST- 2023/08/02 00:00 [accepted]
PHST- 2023/07/31 00:00 [revised]
PHST- 2024/10/01 00:00 [pmc-release]
PHST- 2023/09/27 06:42 [medline]
PHST- 2023/08/15 12:42 [pubmed]
PHST- 2023/08/15 11:10 [entrez]
AID - 10.1007/s13181-023-00961-3 [pii]
AID - 961 [pii]
AID - 10.1007/s13181-023-00961-3 [doi]
PST - ppublish
SO  - J Med Toxicol. 2023 Oct;19(4):381-388. doi: 10.1007/s13181-023-00961-3. Epub 2023 
      Aug 15.