Article ; Online: Electrocardiographic QT Intervals in Infants Exposed to Hydroxychloroquine Throughout Gestation.
Circulation. Arrhythmia and electrophysiology
2020 Volume 13, Issue 10, Page(s) e008686
Abstract: ... Although hydroxychloroquine is generally considered safe during pregnancy based on studies in patients with systemic ... hydroxychloroquine is being considered as prophylaxis and treatment of coronavirus disease-19 (COVID-19 ... hydroxychloroquine blood levels were available in a recently completed study evaluating the efficacy ...
| Abstract | Background: Based on inhibition of viral replication and limited reports on clinical efficacy, hydroxychloroquine is being considered as prophylaxis and treatment of coronavirus disease-19 (COVID-19). Although hydroxychloroquine is generally considered safe during pregnancy based on studies in patients with systemic lupus erythematosus and other rheumatic conditions, there may still be reluctance to institute this antimalarial during pregnancy for the sole purpose of antiviral therapy. Methods: To provide data regarding any potential fetal/neonatal cardiotoxicity, we leveraged a unique opportunity in which neonatal ECGs and hydroxychloroquine blood levels were available in a recently completed study evaluating the efficacy of hydroxychloroquine 400 mg daily to prevent the recurrence of congenital heart block associated with anti-SSA/Ro (anti-Sjögren's Syndrome A/Ro) antibodies. Results: Forty-five ECGs were available for corrected QT interval (QTc) measurement, and levels of hydroxychloroquine were assessed during each trimester of pregnancy and in the cord blood, providing unambiguous assurance of drug exposure. Overall, there was no correlation between cord blood levels of hydroxychloroquine and the neonatal QTc ( Conclusions: In aggregate, these data provide reassurances that the maternal use of hydroxychloroquine is associated with a low incidence of infant QTc prolongation. However, if included in clinical COVID-19 studies, early postnatal ECGs should be considered. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01379573. |
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| MeSH term(s) | Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Antiviral Agents/blood ; Cardiotoxicity ; Drug Administration Schedule ; Drug Monitoring ; Electrocardiography ; Female ; Fetal Blood/metabolism ; Fetal Heart/drug effects ; Fetal Heart/physiopathology ; Gestational Age ; Heart Block/congenital ; Heart Block/diagnosis ; Heart Block/physiopathology ; Heart Block/prevention & control ; Heart Rate/drug effects ; Humans ; Hydroxychloroquine/administration & dosage ; Hydroxychloroquine/adverse effects ; Hydroxychloroquine/blood ; Infant ; Infant, Newborn ; Male ; Predictive Value of Tests ; Pregnancy ; Risk Assessment ; Risk Factors ; Time Factors ; Treatment Outcome |
| Chemical Substances | Antiviral Agents ; Hydroxychloroquine (4QWG6N8QKH) |
| Keywords | covid19 |
| Language | English |
| Publishing date | 2020-09-09 |
| Publishing country | United States |
| Document type | Clinical Trial, Phase II ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't |
| ZDB-ID | 2426129-4 |
| ISSN | 1941-3084 ; 1941-3149 |
| ISSN (online) | 1941-3084 |
| ISSN | 1941-3149 |
| DOI | 10.1161/CIRCEP.120.008686 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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