懷孕藥品風險分類A級的安全藥物－王修含診所皮膚科王修含醫師皮膚科學研究小站

懷孕藥品風險分類A級的安全藥物

皮膚科王修含醫師

懷孕時期的用藥，須相當謹慎，某些藥物可能影響胎兒的成長與安全，造成胎兒的畸形。美國FDA基於懷孕用藥的安全性，將懷孕藥品分為下列五級(詳細定義附於文後)：

Ａ級藥品：安全

Ｃ級藥品：避免使用(對胎兒的影響尚不清楚)，除非治療上的好處大於風險

Ｄ級藥品：避免使用(已證實對胎兒有危險)，除非治療上的利益大於風險

Ｘ級藥品：具有致畸胎性(Teratogenicity)

A級藥品的定義為：「針對懷孕婦女妥善設計，且有對照組的研究中，無法證明使用此藥會增高胎兒異常的危險。」(Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities.)

藥物列表

一般常用藥物甚多，在此以台大醫院常用藥物為例，列出懷孕藥品風險分類A級的安全藥物：(藥物資料來源：台大醫院藥劑部提供)
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學名	懷孕分級	藥品中文名稱	商品名
Acetaminophen	A	安佳熱糖漿	Anti-phen Syrup 24 mg/mL, 60 mL/btl
Acetaminophen	A	伯樂錠８０毫克	Poro Tablet 80 mg/tab
Amorolfine HCl	A	樂指利抗甲癬油劑	Loceryl Nail Lacquer 5% 3 mL/btl
Betahistine Mesylate	A	敏使朗錠	Merislon Tablet 12 mg/tab
Bisacodyl	A	樂可舒腸溶錠	Dulcolax Enteric-coated Tablet 5 mg/tab
Bisacodyl	A	樂可舒栓劑	Dulcolax Suppository 10 mg/pill
Bisacodyl	A	樂可舒腸溶錠	<試> Dulcolax EC-PRUCRC3001 5 mg/tab 30 tab/box
Bromazepam	A	立舒定錠	Lexotan Tablet 3 mg/tab
Cefpirome Sulfate	A	喜活能乾粉注射劑	Cefrom Powder for IV Injection 1 g cefpirome/vial (Na 4.7 mEq/g potency)
Cholera Vaccine (Vibrio cholerae O1 & Cholera toxin B Subunit)	A		Dukoral Inactivated Vaccine 3 mL/vial
Domperidone	A	胃利空懸液劑	Wempty Suspension 60 mg/60 mL/btl
Domperidone	A	道喜錠	Dosin Tablet 10 mg/tab
Folic Acid	A	葉酸錠	Folic Acid Tablet 5 mg/tab
Hydroxocobalamin Acetate	A	維血鎮注射液 (DC)	Bistin Injection 1 mg hydroxocobalamin/1 mL/amp (DC)
Hydroxychloroquine Sulfate	A	必賴克瘻膜衣錠	Plaquenil Tablet 200 mg/tab (equivalent to 155 mg of base)
Hydroxychloroquine Sulfate	A	必賴克瘻錠(旅遊醫學特別門診專用)	Plaquenil Tablet 200 mg/tab (equivalent to 155 mg of base)(旅遊醫學特別門診專用)
Indomethacin	A	炎達益膠囊	Indoy Capsule 25 mg/cap
Indomethacin	A	炎得淨膠囊	Indalgin Capsule 25 mg/cap
Indomethacin	A	穩得滿乳膏 1%	Inteban Cream 1% 25 g/tube
Ketamine HCl	A	克太拉注射劑	@Ketalar Injection 500 mg ketamine/10 mL/vial
Lenalidomide	A		Revlimid 25mg/cap
Levothyroxine Sodium	A	昂特欣錠小兒分包	Eltroxin 25 mcg (= 1/4 tab)/ pack for pediatric use only
Levothyroxine Sodium	A	昂特欣錠100微公克	Eltroxin Tablet 100 mcg/tab
Levothyroxine Sodium	A	昂特欣錠小兒分包	Eltroxin 33.3 mcg(= 1/3 tab)/ pack for pediatric use only
Levothyroxine Sodium	A	活甲錠100微克	Thyroid-S Tablet 100 mcg/tab
Magnesium Sulfate	A	硫酸鎂注射液	Magnesium Sulfate Injection 10% 20 mL/amp ( Mg 0.8 mEq/mL)
Magnesium Sulfate	A	硫酸鎂注射液	Magnesium Sulfate Injection 10% 200 mL/btl ( Mg 0.8 mEq/mL)
Nicorandil	A	喜革脈錠	Sigmart Tablet 5 mg/tab
Oxytocin	A	歐利生注射液	Oxytocin Injection 10 IU/1 mL/amp
Prochlorperazine Maleate	A	諾安命錠	Novamin Tablet 5 mg prochlorperazine/tab
Pyridoxal Phosphate	A	俾燐勝注射液２０公絲	Pyridoxal Phosphate 20 mg/ 2 mL/ amp
Pyridoxine HCl	A	維六素錠	Beesix Tablet 50 mg/tab
Sodium Chloride	A		Sodium Chloride 0.9% 20 mL/amp (15.38 mEq /100 mL)
Sodium Chloride	A	氯化鈉注射液0.45%	Sodium Chloride 0.45% 500 mL/bag (7.7 mEq/100 mL)
Sodium Chloride	A	沙林注射液0.45%	Salilne 0.45% 500 mL/bag (7.7 mEq /100 mL)
Tenoxicam	A	炎克欣凍晶注射劑	Tencam for Injection 20 mg/vial
Thiamine HCl	A	維他命乙１注射液	Vitamin B1 Inj. 100 mg/2 mL/amp
Tiaprofenic Acid	A	司健錠	Surgam Tablet 200 mg/tab
Tropisetron HCl	A	耐嘔伴靜脈注射液	Navoban Injection 5 mg tropisetron/5 mL/amp (DC)
Zinc Oxide	A	氧化鋅軟膏	Zinc Oxide Ointment 20% 28.4 g/tube
Zinc Sulfate	A	硫酸鋅注射液	Zinc Sulfate 29.7mg ZnSO₄.7H₂O/5mL/amp(Zn 6.75mg/amp)

懷孕藥物分類(US FDA Pregnancy category definitions)：

級別 Category	定義/描述 Definition/Description
A	針對懷孕婦女妥善設計，且有對照組的研究中，無法證明使用此藥會增高胎兒異常的危險。 Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities.
B	動物試驗的結果顯示，並無對胎兒有害的證據，但缺乏針對懷孕婦女進行妥善設計且有對照組的研究。(Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women.) 或(or) 雖然動物試驗顯示對胚胎有不良作用，但針對懷孕婦女的對照研究中，無法證明對於胎兒的危險性。(Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus.)
C	動物試驗顯示對胚胎有不良作用，但缺乏針對人類懷孕婦女妥善設計且有對照組的研究。(Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women.) 或(or) 針對動物或人類懷孕婦女，目前缺乏妥善設計且有對照組的研究，可證明此藥物的危險性。(No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.)
D	針對孕婦的控制實驗或觀察研究中，已證實此藥對胎兒有危險性。但在考量利弊得失下，此藥對於治療的利益可能大於潛在的危險性。 Studies, adequate well-controlled or observational, in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk.
X	針對動物或孕婦的控制實驗或觀察研究中，已顯示此藥會造成胚胎異常，而且禁用於已經或可能懷孕的婦女。(註：藥物導致的傷害大於可能的利益) Studies, adequate well-controlled or observational, in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. The use of the product is contraindicated in women who are or may become pregnant.