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Doxycycline Pregnancy and Breastfeeding Warnings

Doxycycline is also known as: Acticlate, Adoxa, Adoxa CK, Adoxa TT, Alodox, Avidoxy, Doryx, Doxy 100, Doxy 200, Doxy-Caps, Doxy-D, Doxy-Lemmon, Monodox, Morgidox, Ocudox, Oracea, Oraxyl, Periostat, Uracil, Vibra-Tabs, Vibramycin

Doxycycline Pregnancy Warnings

FDA pregnancy category: D IV: Use is not recommended unless essential for the patient's welfare (per physician judgment). Most oral formulations: Doxycycline should not be used during pregnancy unless the benefit outweighs the risk. Oracea(R): Use is not recommended. Comments: -Except for anthrax (including inhalation anthrax [postexposure]), tetracycline drugs should not be used during tooth development unless other drugs contraindicated or unlikely to be effective. -If any tetracycline is used during pregnancy or if the patient becomes pregnant while using these drugs, she should be informed of the potential risk to the fetus. -Oracea(R) should be stopped at once if patient becomes pregnant.

Animal studies have revealed evidence of embryo- and fetotoxicity, including toxic effects on skeletal formation. Animal studies indicate doxycycline crosses the placenta and is found in fetal tissues. There are no controlled data in human pregnancy. However, congenital defects have been reported with the class of tetracyclines. Fetal effects may be dose-related. When used during tooth development (second half of pregnancy) tetracyclines may cause permanent yellow-gray-brown discoloration of the teeth and enamel hypoplasia. An expert review of doxycycline use during pregnancy by the Teratogen Information System (TERIS) concluded that substantial teratogenic risk from therapeutic doses during pregnancy is unlikely (data quantity and quality limited to fair); insufficient data to state there is no risk. Population-based data from the Hungarian Case-Control Surveillance of Congenital Abnormalities revealed that of 32,804 women who had infants with no defects, 63 (0.19%) were treated with doxycycline during pregnancy. Of 18,515 women who had infants with congenital abnormalities, 56 (0.3%) were treated with doxycycline. This study showed a weak but marginally statistically significant association with total malformations and doxycycline use anytime during pregnancy. This association was not seen when analysis was limited to maternal therapy during organogenesis (i.e., second and third months of gestation), except for a marginal association with neural tube defect based on 2 exposed cases. Data were based on retrospective recall and did not include alcohol or tobacco usage. In a small prospective study (81 pregnancies), 43 pregnant women were treated with doxycycline for 10 days during early first trimester. All mothers reported their exposed infants were normal at 1 year of age. In mass casualty settings after release of biological weapons, the Working Group on Civilian Biodefense has recommended doxycycline as an alternative drug for prophylaxis and treatment of anthrax, tularemia, and plague. The risk of doxycycline use during pregnancy is outweighed by the high fatality rates from these infections. FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Doxycycline Breastfeeding Warnings

The extent of doxycycline absorption by breastfed infants is unknown. Short-term use in lactating women is not explicitly contraindicated by most manufacturers, but the effects of prolonged doxycycline exposure via breast milk are unknown. Long-term or repeat courses are not recommended during nursing as a theoretical precaution. Theoretical risks of dental staining and inhibition of bone growth in nursing infants are considered unlikely by most experts. Available data indicate that short-term use of doxycycline during lactation is unlikely to be harmful; milk levels are low and calcium in breast milk may inhibit infant absorption. Short-term doxycycline use in nursing mothers is generally considered acceptable by experts. After 2 doses of oral doxycycline (200 mg followed by 100 mg 12 hours later) in 15 nursing mothers, milk doxycycline levels 3 and 24 hours after dosing averaged 0.77 and 0.38 mg/L, respectively. Oral doxycycline (100 mg per day) was given to 10 mothers. On day 2, milk doxycycline levels 3 and 24 hours after dosing averaged 0.82 and 0.46 mg/L, respectively. Using peak and trough milk level averages in this study, the estimated intake of an infant only fed breast milk averaged about 6% of the maternal weight-adjusted dose. Peak milk levels averaged 0.96 mg/L after a single 100 mg dose (n=3) and 1.8 mg/L after a single 200 mg dose (n=3). After 100 mg orally twice a day for 5 days, milk doxycycline levels were about 3.6 mg/L. In another study, in the immediate postpartum period, peak milk levels were 0.6 mg/L after oral doses of 100 mg (n=3) and averaged 1.1 mg/L after 200 mg (n=11). After a single 200 mg doxycycline dose (n=2), milk levels 2, 4, and 6 hours after the dose averaged 0.8, 0.7, and 0.4 mg/L, respectively.

IV: The manufacturer makes no recommendation regarding use during lactation. Most oral formulations: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Doxycycline hyclate 20 mg: Use is contraindicated. Oracea(R): Use is not recommended. Excreted into human milk: Yes Excreted into animal milk: Data not available Tetracycline (a related drug) is considered compatible with breastfeeding by the American Academy of Pediatrics.

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