[藥訊] 美國FDA藥品-懷孕等級分別制度 @ Miss MiMi

好的～這是第一篇藥訊

一直在想要從哪方面寫起,但後來決定要從孕婦藥品等級分別制度開始說起

首先 FDA (Food and Drug Administration) 依照懷孕時服用的風險,將大部分的藥品分爲五類

Pregnancy Category A, B, C, D, X

Pregnancy A----安全

Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters)

意思就是經過研究調查顯示-人體實驗後對懷孕第一周期的胚胎不會有危險,對之後周期的也是

Pregnancy B----相對安全

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women

意思就是動物繁衍實驗的結果是安全的,而對於懷孕的女人們沒有適當的研究,在實務上我們可以說這類別的藥是可以服用的！

ex: Acetaminophen (Tylenol, Feverall)

Pregnancy C----相對危險

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

動物繁衍實驗後顯示會有副作用,而對於人類則沒有適當的研究,但是儘管有可能有副作用,如果他的好處勝過副作用的話則考慮可服用！

ex: Pseudoephrine+ Loratadine (Claritin-D 12 hour)

Pregnancy D----危險

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 potental risks.

經研究發現對人體胚貼會有副作用,但是儘管有可能有副作用,如果他的好處勝過副作用的話則考慮可服用！但是實務上我們不推薦懷孕婦女服用！

ex: Ibuprofen (Advil, Motrin) in 3rd trimester

Pregnancy X----非常危險

Studies in animals or humans have demonstrate fetal abnormalities and/ or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risk involved in use of the drug in pregnant women clearly outweigh potential benefits

經研究發現,動物或人類實驗後胚胎會造成不正常或者會有副作用.這類的副作用或不正常是不可允許的. 懷孕婦女萬萬不可用！

ex: Orlistat (Alli)