Doxycycline use and adverse pregnancy or neonatal outcomes: A descriptive study using the United States Food and Drug Administration Adverse Event Reporting System database
Abstract Background and Aims Doxycycline is recommended for use in rickettsial diseases. The available evidence regarding its safety for rickettsial infection in pregnancy is limited. Our study aimed to describe the adverse events of doxycycline when used during pregnancy for any indication, in term...
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| Format: | Article |
| Language: | English |
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Wiley
2022-11-01
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| Series: | Health Science Reports |
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| Online Access: | https://doi.org/10.1002/hsr2.931 |
| _version_ | 1797772316321513472 |
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| author | Sammodavardhana Kaundinnyayana Ashwin Kamath |
| author_facet | Sammodavardhana Kaundinnyayana Ashwin Kamath |
| author_sort | Sammodavardhana Kaundinnyayana |
| collection | DOAJ |
| description | Abstract Background and Aims Doxycycline is recommended for use in rickettsial diseases. The available evidence regarding its safety for rickettsial infection in pregnancy is limited. Our study aimed to describe the adverse events of doxycycline when used during pregnancy for any indication, in terms of adverse maternal and/or neonatal outcomes, using the United States Food and Drug Administration Adverse Event Reporting System (FAERS). Methods We used the OpenVigil software for extracting the safety reports from the United States submitted to the FAERS from 2004 to 2021. We manually reviewed reports of doxycycline use resulting in adverse pregnancy outcomes or congenital anomalies to describe the patient and safety event characteristics. Results From 2004 to 2021, 59 individual case safety reports containing preferred terms indicative of drug exposure during pregnancy or drug‐induced adverse fetal outcomes were identified in the FAERS database. Following deduplication and manual review, 20 relevant adverse event reports were obtained. Doxycycline was the suspect medication in 13/20 (65%) reports. The common adverse event terms reported were premature delivery/baby in 6 reports, spontaneous abortion in 6, intrauterine death in 2, and various congenital anomalies in the rest. Fifty percent of the safety reports contained other medications which could have potentially caused the outcome. Conclusions The number of reported events in the FAERS database of adverse pregnancy/neonatal outcomes following doxycycline use is small, similar to the numbers reported from large cohort or surveillance studies. Given the presence of concomitant medications that could have contributed to the outcome, there does not seem to be a strong signal of harm, although this needs to be confirmed by surveillance studies. |
| first_indexed | 2024-03-12T21:50:18Z |
| format | Article |
| id | doaj.art-8b7c4730c262433db707b109823aea08 |
| institution | Directory Open Access Journal |
| issn | 2398-8835 |
| language | English |
| last_indexed | 2024-03-12T21:50:18Z |
| publishDate | 2022-11-01 |
| publisher | Wiley |
| record_format | Article |
| series | Health Science Reports |
| spelling | doaj.art-8b7c4730c262433db707b109823aea082023-07-26T04:31:47ZengWileyHealth Science Reports2398-88352022-11-0156n/an/a10.1002/hsr2.931Doxycycline use and adverse pregnancy or neonatal outcomes: A descriptive study using the United States Food and Drug Administration Adverse Event Reporting System databaseSammodavardhana Kaundinnyayana0Ashwin Kamath1Department of Pharmacology, Nepalese Army Institute of Health Sciences College of Medicine Kathmandu NepalDepartment of Pharmacology, Kasturba Medical College, Mangalore Manipal Academy of Higher Education Manipal IndiaAbstract Background and Aims Doxycycline is recommended for use in rickettsial diseases. The available evidence regarding its safety for rickettsial infection in pregnancy is limited. Our study aimed to describe the adverse events of doxycycline when used during pregnancy for any indication, in terms of adverse maternal and/or neonatal outcomes, using the United States Food and Drug Administration Adverse Event Reporting System (FAERS). Methods We used the OpenVigil software for extracting the safety reports from the United States submitted to the FAERS from 2004 to 2021. We manually reviewed reports of doxycycline use resulting in adverse pregnancy outcomes or congenital anomalies to describe the patient and safety event characteristics. Results From 2004 to 2021, 59 individual case safety reports containing preferred terms indicative of drug exposure during pregnancy or drug‐induced adverse fetal outcomes were identified in the FAERS database. Following deduplication and manual review, 20 relevant adverse event reports were obtained. Doxycycline was the suspect medication in 13/20 (65%) reports. The common adverse event terms reported were premature delivery/baby in 6 reports, spontaneous abortion in 6, intrauterine death in 2, and various congenital anomalies in the rest. Fifty percent of the safety reports contained other medications which could have potentially caused the outcome. Conclusions The number of reported events in the FAERS database of adverse pregnancy/neonatal outcomes following doxycycline use is small, similar to the numbers reported from large cohort or surveillance studies. Given the presence of concomitant medications that could have contributed to the outcome, there does not seem to be a strong signal of harm, although this needs to be confirmed by surveillance studies.https://doi.org/10.1002/hsr2.931adverse drug eventcongenital abnormalitiesdoxycyclinepregnancyrickettsia infections |
| spellingShingle | Sammodavardhana Kaundinnyayana Ashwin Kamath Doxycycline use and adverse pregnancy or neonatal outcomes: A descriptive study using the United States Food and Drug Administration Adverse Event Reporting System database Health Science Reports adverse drug event congenital abnormalities doxycycline pregnancy rickettsia infections |
| title | Doxycycline use and adverse pregnancy or neonatal outcomes: A descriptive study using the United States Food and Drug Administration Adverse Event Reporting System database |
| title_full | Doxycycline use and adverse pregnancy or neonatal outcomes: A descriptive study using the United States Food and Drug Administration Adverse Event Reporting System database |
| title_fullStr | Doxycycline use and adverse pregnancy or neonatal outcomes: A descriptive study using the United States Food and Drug Administration Adverse Event Reporting System database |
| title_full_unstemmed | Doxycycline use and adverse pregnancy or neonatal outcomes: A descriptive study using the United States Food and Drug Administration Adverse Event Reporting System database |
| title_short | Doxycycline use and adverse pregnancy or neonatal outcomes: A descriptive study using the United States Food and Drug Administration Adverse Event Reporting System database |
| title_sort | doxycycline use and adverse pregnancy or neonatal outcomes a descriptive study using the united states food and drug administration adverse event reporting system database |
| topic | adverse drug event congenital abnormalities doxycycline pregnancy rickettsia infections |
| url | https://doi.org/10.1002/hsr2.931 |
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