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Retrospective Assessment of the Use of Pharmacotherapeutic Agents in Pregnancy with Potential Impact on Neonatal Health

K. Podolská

K. Podolská

Department of Applied Pharmacy, Faculty of Pharmacy, Masaryk UniversityBrno, Czech Republic
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Podolská, K.
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D. Mazánková

D. Mazánková

Department of Applied Pharmacy, Faculty of Pharmacy, Masaryk UniversityBrno, Czech Republic
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Mazánková, D.
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M. Göböová

M. Göböová

Department of Internal Medicine, Teaching Hospital NitraNitra, Slovakia
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Göböová, M.
  
Aug 23, 2022
Retrospective Assessment of the Use of Pharmacotherapeutic Agents in Pregnancy with Potential Impact on Neonatal Health's Cover Image
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Article Category: Original Paper
Published Online: Aug 23, 2022
Page range: 17 - 25
Received: Mar 03, 2022
Accepted: Jun 20, 2022
DOI: https://doi.org/10.2478/afpuc-2022-0015
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© 2022 K. Podolská et al., published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Figure 1

The most frequently used therapeutic agents classified to particular code of Anatomical Therapeutic Chemical (ATC) classification system. ATC first level classification was used. P1–P22 represents Patient 1–Patient 22. Each patient could have used more than one therapeutic agent.
The most frequently used therapeutic agents classified to particular code of Anatomical Therapeutic Chemical (ATC) classification system. ATC first level classification was used. P1–P22 represents Patient 1–Patient 22. Each patient could have used more than one therapeutic agent.

Figure 2

Health conditions of newborns from a total of 22 adult female patients after being exposed to therapeutic agents. UN = unspecified information about newborn; SA = spontaneous abortion; CD = congenital defect or malformation; IL = illness of newborn; HL = healthy newborn.
Health conditions of newborns from a total of 22 adult female patients after being exposed to therapeutic agents. UN = unspecified information about newborn; SA = spontaneous abortion; CD = congenital defect or malformation; IL = illness of newborn; HL = healthy newborn.

Figure 3

View on foetal risk summary according to outcomes per therapeutic agent usage during pregnancy.
View on foetal risk summary according to outcomes per therapeutic agent usage during pregnancy.

Overview on therapeutic agents with confirmed foetal risk and their outcomes_

Drugs with confirmed foetal risk Level of confirmed foetal risk-guide to foetal and neonatal risk (Briggs et al., 2017; Schaefer et al., 2015) Minimizing the potential risk for given therapeutic agents Stage of pregnancy during medication usage, dose, and duration of treatment Number of patients (N = 22) Outcome of pregnancy
Valproic acid 2 to 3 times increased risk of congenital anomalies Human data suggest risk Antiepileptic polytherapy with valproate is not preferred (State Institute for Drug Control [ŠÚKL] 2018c).To minimize the risk, use of the lowest effective dose divided into several doses during the day is recommended (ŠÚKL 2018c). Preventive usage of folic acid before pregnancy and during pregnancy to lower neural tube defects and creation of congenital malformations is recommended (ŠÚKL 2018c). 5th–6th week (2nd month, 1st trimester), 300 mg, previous long-term treatment 1 Spontaneous abortion
Eletriptan No clinical data, no harmful effect in animal data No human data; animal data suggest moderate risk To minimize the risk, the lowest effective dose is recommended (Briggs et al., 2017). 2nd–5th week (1st month, 1st–2nd trimester), 20 mg, 2–3 weeks 1 Healthy newborn
Venlafaxine hydrochloride Animal studies show reproductive toxicity Human data suggest risk in 3rd trimester Preferred is monotherapy and usage of the lowest but most effective dosing.If possible, it is recommended to discontinue the drug treatment 1–2 weeks before birth (Seifertová et al., 2007). Ø, 75 mg 1× a day, 1 week 1 Healthy newborn
Interferon ß-1a Increased risk of spontaneous abortions Initiation of treatment is contraindicated Limited human data; animal data suggest moderate risk The injection site for the intramuscular injection must be changed weekly (ADC ČÍSELNÍK, 2018).Before the application of the injection and after 24 hours after injection, it is recommended to give antipyretic analgesic agents to relieve the flu-like symptoms that occur with inteferon ß-1a. These symptoms usually appear during the first few months of treatment (ADC ČÍSELNÍK, 2018). Time of conception, 30 μg, patient used Avonex regularly 1 Birth defect (unspecified)
Methylprednisolon sodium succinate In animal studies foetal malformation was observed Risk of low birth weight Human data suggest risk The risk of low birth weight is dose-dependent and can be minimized by administering lower doses of corticosteroids (ŠÚKL 2018d). Time of conception, 40 mg, 2 weeks 1 Birth defect (unspecified)
Budesonide Teratogenic potential in animal studies Compatible (inhaled/nasal); no human data; animal data suggest risk There is no more detailed information, but adequate maintenance treatment of asthma during pregnancy is important (Liekinfo 2018a). 3rd week (1st month, 1st trimester), 200 μg–400 μg, 2 days 1 Illness (Wilm's tumour)
Duloxetine Animal studies show reproductive toxicitySSRI in advance stage may increase the risk of PPHN Human data suggest risk in the 3rd trimester Monotherapy is preferred.To minimize the risk, use of the lowest effective dose is recommended.If possible, it is recommended to discontinue the drug treatment 2 weeks before birth (Seifertová et al., 2007). 8th week (2nd month, 1st trimester), 30 mg /60 mg in the morning, 4 weeks 1 Healthy newborn
Moclobemide Safety for pregnant woman has not been established Ø Monotherapy is preferred.To minimize the risk, usage of the lowest effective dose is recommended.If possible, it is recommended to discontinue the drug treatment 2 weeks before birth (Seifertová et al., 2007). 8th week (2nd month, 1st trimester), 300 mg in the morning, 6 weeks 1 Healthy newborn
Clonazepam May cause birth defectsAs an anticonvulsive agent, it can be teratogenic Human data suggest low risk Potential toxicity if combined with other CNS depressants There is no more detailed information. 8th week (2nd month, 1st trimester), 2 mg, 8 weeks 1 Healthy newborn
Ciprofloxacin Neither animal nor human studies indicate malformative or foetal/neonatal toxicityDrug can cause damage to articular cartilage in the foetus Contraindicated; used only if no other alternatives There is no more detailed information. 1. 2nd–3rd week (1st month, 1st trimester), 500 mg, 10 days2. 1st–2nd week (1st month, 1st trimester), 500 mg, every 12 hrs, 1 week3. 1st–3rd week (1st month, 1st trimester), 250 mg, 2 weeks 3 1. Healthy newborn2. Healthy newborn3. Healthy newborn
Doxycycline In foetus and children, dental decay and reversible retardation of skeletal development may occur Contraindicated in 2nd and 3rd trimesters There is no more detailed information. 1. 1st–2nd week (1st month, 1st trimester), 200 mg, 1× a day, 20 days2. 5th–6th week (2nd month, 1st trimester), 100 mg, 1× a day, 10 days3. 1st–2nd week (1st month, 1st trimester), 200 mg, 1 week 3 1. Healthy newborn, born in 8th month2. Healthy newborn3. Healthy newborn
Amoxicillin, clavulonic acid Animal studies do not indicate the harmful effect Human studies do not show an increased risk of congenital malformations Human data suggest risk in 1st and 3rd trimesters There is no more detailed information. Ø, 125 mg, 2 weeks before conception 1 Healthy newborn
Betahistine dihydrochloride Animal studies are inadequate Potential risk to humans is unknown No documented experiences are available for the histamine analogue betahistine. There is no more detailed information. 5th–6th week (2nd month, 1st trimester), 24 mg, 2× a day, 3 weeks 1 Healthy newborn
Norethisterone acetate Adversely affects the development of the foetus Contraindicated There is no more detailed information. 5th week (2nd month, 1st trimester), 5 mg, 7 days 1 Spontaneous abortion
Bisulepine hydrochloride Safety has not been verifiedIt is not recommended to use, especially during 1st trimester No human data There is no more detailed information. 1st week (1st month, 1st trimester), 2 mg, 1 week 1 Healthy newborn
Monohydrate sodium salt of metamizole There is no evidence that drug damages the foetusPossible to use in the 2nd trimester Ø There is no more detailed information Ø, 500 mg, 3 days 1 Illness (heart murmur)
Tetrazepam Usage should be avoided in the first three monthsMedication should be used occasionally Human data suggest risk in 1st and 3rd trimesters It is recommended to avoid the use of benzodiazepines during the first three months of pregnancy.Increased doses should not be used during the last three months of pregnancy, as neonatal hypotension and respiratory disorders may occur in neonates (Liekinfo 2018b). 2nd–4th week (1st month, 1st trimester), 50 mg, 1× every night, 8 days 1 Healthy newborn
Piroxicam β-cyclodext rine ContraindicatedSafety has not been established Human data suggest risk in 1st and 3rd trimesters There is no more detailed information. 2nd–4th week (1st month, 1st trimester), 20 mg, 1× every morning, 7 days 1 Healthy newborn
Prednisone Not suitable, signs of hypoadrenalism in newborns Human data suggest risk There is no more detailed information. Ø, 20 mg, Ø 1 Unspecified information (patient overcame 3 SABs and is planning pregnancy)
Allopurinol Animal studies show teratogenic potentialIn human studies without apparent adverse effects Contraindicated There is no more detailed information. Ø, 300 mg, Ø 1
Nadroparin No teratogenic or foetotoxic effects were observed in animal studiesLimited human clinical data Ø There is no more detailed information. Ø, Ø, Ø 1
Fluvastatin Can cause foetal harmContraindicated during pregnancy Contraindicated in the 1st trimester There is no more detailed information on how to minimalize risk. Using of this agent is contraindicated during pregnancy (ŠÚKL, 2018b). Ø, 80 mg, 6 weeks 1
Chlorprothixene chloride Newborns exposed to antipsychotics during the third trimester are at risk of extrapyramidal symptomsReproduction studies in animals have not shown an increased incidence of foetal harm Human data suggest risk mainly in the 3rd trimester If medication cannot be discontinued, it is possible to reduce the antipsychotic dose to the minimum effective level, especially in the first trimester.Monotherapy is preferred. We do not discontinue the antipsychotic even before delivery (Seifertová et al., 2007).In maintenance therapy, it is better to administer a minimal dose of an antipsychotic continuously than to administer high doses intermittently to decompensate the condition (Seifertová et al., 2007). Beginning of 2nd month, (1st trimester), 50 mg, 2 weeks 1 Healthy newborn
Ibuprofen May adversely affect pregnancy and/or embryonal or foetal development Human data suggest risk in the 1st and 3rd trimesters The risk is expected to increase with the dose and duration of treatment. Ibuprofen should not be used during 1st and 2nd trimesters unless clearly necessary. If ibuprofen is used by a woman trying to become pregnant or during the 1st and 2nd trimesters of pregnancy, she should take low doses, and the treatment should be as short as possible (ŠÚKL, 2018a). Beginning of 2nd month (1st trimester), 400 mg, 8 weeks 1 Healthy newborn
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