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 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.

Drugs associated with a risk of supraventricular tachycardia: analysis using the OpenVigil database

“…However, the database may be biased by a number of confounding factors; identification of drugs that may cause SVT in the OpenVigil database does not indicate a drug–adverse event causal association. 43 , 44 Additionally, in our study, drugs found in the OpenVigil database that could potentially cause SVT were further assessed using the Hangzhou Yiyao Rational Use System, SIDER database, and several research literature databases. However, the aforementioned sources have a certain lag time, such as lengthy update time of drug specifications.…”

Lymphangioleiomyomatosis and pregnancy: a mini-review

“…Doxycycline is effective for the treatment of LAM [ 56 ], but the use of doxycycline during pregnancy has historically been discouraged due to potential adverse effects on the fetal teeth during 16 weeks postconception. Although a study assessed doxycycline use during pregnancy [ 57 ], the data are insufficient to state that there is no risk. So clinical trial guidelines do not suggest the use of doxycycline as a treatment for LAM because there are no beneficial effects in LAM patients who already have lung function impairment.…”

Murine Typhus: A Review of a Reemerging Flea-Borne Rickettsiosis with Potential for Neurologic Manifestations and Sequalae

“…Most pregnant women with murine typhus have favorable outcomes, but poor neonatal outcomes from those with suboptimal treatment have been reported [163,164]. Doxycycline does not seem to be associated with the severe adverse events in pregnant women that have been reported with older tetracyclines [165,166].…”