بر اساس دارونامه این وبلاگ، هر دارو با یکی از حرفهای D ،C ،B ،A یا X در یکی از گروههای بارداری قرار میگیرد. این پنچ گروه را سازمان غذا و دارو* برای نشان دادن میزان خطر هر دارو در ایجاد «نقص تولد» تعریف کرده است.
A: مطالعات کنترل شده هیچ خطری را نشان نمیدهند.
B: هیچ خطری در انسانها مشاهده نشده است.
C: احتمال خطر وجود دارد.
D: خطرناک است.
X: در بارداری ممنوعیت مصرف دارد.
پیش از مصرف دارو در دوران بارداری چه چیزی را باید بدانم؟
همواره باردار بودن خود را به داروساز، پزشک و دندانپزشک گوشزد کنید.
همواره در مورد مصرف هر دارو یا مکملی با پزشک متخصص زنان و زایمان خود مشورت کنید.
همواره به بارداری خود اهمیت دهید و بدانید که دارو، غذا نیست.
A: Controlled studies show no risk.
- Controlled studies in pregnant women fail to demonstrate risk to the fetus in the first trimester with no evidence of risk in later trimesters. The possibility of fetal harm appears remote.
B: No evidence of risk in humans.
- Either animal-reproduction studies have not demonstrate a fetal risk, but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an 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: Risk cannot be ruled out.
- 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: Positive evidence of risk.
- There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg, 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: Contraindicated in pregnancy.
- 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 use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
References:
Lexi-Comp is the official drug reference for the American Pharmacist Association.
UpToDate is an evidence based, peer reviewed information resource.
*FDA: Food and Drug Administration
- Controlled studies in pregnant women fail to demonstrate risk to the fetus in the first trimester with no evidence of risk in later trimesters. The possibility of fetal harm appears remote.
B: No evidence of risk in humans.
- Either animal-reproduction studies have not demonstrate a fetal risk, but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an 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: Risk cannot be ruled out.
- 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: Positive evidence of risk.
- There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg, 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: Contraindicated in pregnancy.
- 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 use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
References:
Lexi-Comp is the official drug reference for the American Pharmacist Association.
UpToDate is an evidence based, peer reviewed information resource.
*FDA: Food and Drug Administration
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