FDA懷孕分級資料查詢

US FDA Pregnancy Category Definitions
A Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of a risk in later trimesters), and the possibility of fetal harm appears remote.
B Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters).
C Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
D There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
X Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
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藥品代號 學名 懷孕分級 說明
16M019 Magnesium Sulfate(0.8meq/ml)針 A 安全
27E036 Eltroxin (0.1mg) 錠. A 安全
27I026 Iron A 安全
27V146 Pyridoxine HCl (Vitamin B6)® 10mg/Tab A 安全
27L051 Levothyroxine (Eltroxin)® 50mcg /tab A 安全
10A091 Myozyme (50mg/V) 針. B 可能安全
10B014 Simulect (20mg/V) 針 B 可能安全
10E023 Enbrel (25mg/ml)針. B 可能安全
10E081 Enbrel(25mg)針筒裝注射劑 B 可能安全
10G027 Copaxone(20mg) 針. B 可能安全

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