임산부에서 감기 증상 치료 약제, 효능, 안전성, Common cold, pregnancy, drugs

임산부인 한 환자가 두통이 심하고

콧물,재채기 증상이 심하여 내원하였습니다.

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"약을 안 먹고 좋아질 수 있는 방법이 없나요?"

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임산부가 감내하기 힘들다면 처방할 수 있는 FDA category B에 해당하는 약물은 chlorpheniramine(콧물, 재채기), acetaminophen(두통)입니다.

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감기에 걸린 임산부에게는

비록 기침이 더 길게 남아 있을 수 있으나

일반적으로 10일 이내에 증상이 호전된다고 안심시킵니다.

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약물 치료가 약간의 증상을 경감시킬 수 있으나

치료가 증상 기간을 단축시지 못하며

임산부에서 감기에 대한 약물 치료 위험성이

무작위 연구에서 확인되지 않았습니다.

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질환이 저절로 호전되며

모든 가능한 치료의 효능이 제한되고

안전성의 강한 증거가 없다고

공지되었음에도 불구하고

환자가 여전히 증상 경감을 위한 약물을 원한다면

태아에 해가 없다는 강한 증거가 있는 약제를 선택해야 합니다.

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감기 치료를 위해 사용되는 몇 가지 약물들의 안정성과 효능에 대한 자료는

다음과 같습니다. Ref. UpToDate 2016.12.27

Agents used to treat the common cold and its symptoms, efficacy and safety in pregnancy

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1. Antipyretics and simple analgesics

1) Acetaminophen

① Effect in randomly controlled trial (not pregnant)

: Antipyretic and symptomatic relief of associated myalgias, headaches and sore throat

② Pregnancy data

: FDA pregnancy category B.

Extensive animal data and population-based studies are very reassuring

regarding the safety of this agent in pregnancy.

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2) Nonsteroidal anti-inflammatory drugs (NSAIDs)

① Effect in randomly controlled trial (not pregnant)

: Reductions in headache, malaise, myalgia with a 29 percent reduction

in the total (5-day) symptom score. Has no effect on nasal symptoms.

② Pregnancy data

: Most NSAIDs are FDA pregnancy category C/D in the third trimester.

NSAID exposure during the first trimester is not strongly associated with congenital malformations; however, cardiovascular anomalies, cleft palate, and gastroschisis have been observed following NSAID exposure in some studies. The absolute risk appears to be low. The use of a NSAID close to conception may be associated with an increased risk of miscarriage. NSAIDs have been associated with oligohydramnios, pulmonary hypertension, intracranial hemorrhage, and necrotizing enterocolitis in infants born prematurely. Their use in pregnancy is not appropriate for the treatment of common cold symptoms. Acetaminophen will offer similar relief in this setting without placing the fetus at increased risk.

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2. Antihistamines

※ Diphenhydramine

Chlorpheniramine

Fexofenadine

Loratidine

Clemastine

Brompheniramine

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① Effect in randomly controlled trial (not pregnant)

: Clemastine and brompheniramine (and loratadine in conjunction with pseuedoephedrine) decrease sneezing and nasal discharge but have no effect on sore throat, cough, headache and malaise. No antihistamine effects total symptom score or duration for the common cold.

② Pregnancy data

: FDA pregnancy classification B and C.

Chlorpheniramine and diphenhydramine have mostly reassuring pregnancy data and should be considered the preferred antihistamines in pregnancy. Most of the older antihistamines are not considered to increase the incidence of congenital malformations in humans. Although some antihistamines have been associated with oral clefts in retrospective studies others have found no significant increase in the incidence of major or minor malformations and one study even found that significantly fewer infants with malformations were exposed to antihistamines while in utero than were controls. There are limited human pregnancy data on the newer antihistamines fexofenadine, cetirizine, and loratadine. Therefore, they should not be used as first line agents in pregnancy. Use of antihistamine with women in pre-term labor was associated in one study with an increased risk of retrolental fibroplasias and should be avoided in this setting.

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3. Cough medicine

※ Codeine

Dextromethorphan

Guaifenisin

Benzonatate

Hydrocodone

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① Effect in randomly controlled trial (not pregnant)

: Uniformly ineffective in the setting of cough from common cold.

② Pregnancy data

: All FDA pregnancy classification C.

Animal data for codeine, dextromethorphan and hydrocodone conflicting.

Human data for all these agents are poor. Guaifenisin was associated with inguinal hernias in one study only. A large case-control study observed an association between first trimester use of

opioids and various congenital anomalies. Neonatal withdrawal has been reported in babies born both to addicted and non-addicted women who took codeine in the days prior to delivery. Codeine ingestion near the time of labor can produce respiratory depression in the newborn.

The lack of efficacy of these agents suggests their use is not justifiable in pregnancy for the common cold especially given questions about the safety of some of these agents in pregnancy.

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4. Decongestants

※ Oral: Pseudoephedrine

Ephedrine

Phenylephrine

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① Effect in randomly controlled trial (not pregnant)

: Short lived mild relief of obstruction with single use. No evidence of sustained effects. Spray decongestants associated with rebound effects upon withdrawal.

② Pregnancy data

: All FDA pregnancy classification C.

Most commonly used decongestants are in need of further study before they can be definitively considered safe in pregnancy. Present data is variable but these agents probably represent a low risk. Oxymetazoline is the preferred intranasal agent but use for mild symptoms should be discouraged in pregnancy. No clear human teratogenic effect and no effect on uterine blood flow in the setting of normal nasal mucosa but concerns exist about its possible effects on uterine blood flow in the setting of overuse, inflamed nasal mucosa and in cases were poor placental perfusion is already suspected. Pseudoephedrine should be avoided in the first trimester. Two studies have suggested an increased risk of gastroschisis. Later in pregnancy, it is probably the preferred oral agent among the oral decongestants. This agent is less likely to raise blood pressure than the other oral decongestants.

Ephedrine is teratogenic in chicks even at small doses. No evidence of human teratogenesis but data are limited. Phenylephrine has been associated with a wide range of congenital anomalies in humans and dramatic effects on uterine blood flow in sheep. This agent should be avoided at all stages of pregnancy. The uterine vessels are maximally dilated and have only alpha-adrenergic receptors. The alpha-adrenergic stimulant phenylephrine will cause constriction of these vessels, resulting in reduced uterine blood flow, fetal hypoxia, and subsequent bradycardia.

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