Sử dụng thuốc trong thai kỳ
FDA phân loại có 5 mức độ ảnh hưởng của dược phẩm trên thai kỳ A, B, C, D, X.
Hãy nêu một số thuốc và ảnh hưởng trên thai kỳ đối với các nhóm thuốc:
Pregnancy Category A 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
Pregnancy Category B Animal reproduction studies have failed to demonstrate a
risk to the fetus and there are no adequate and well-controlled studies in pregnant
women OR 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
Pregnancy Category C 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
Pregnancy Category D 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
Pregnancy Category X Studies in animals or humans have demonstrated fetal
abnormalities and/or there is positive evidence of human fetal risk based on
adverse reaction data from investigational or marketing experience, and the risks
involved in use of the drug in pregnant women clearly outweigh potential benefits.
Xin cho vài ví dụ 1 số thuốc hay gặp trên lâm sàng:
- Sulfamethoxazole: C nếu gần sinh là D
- Perindopril: C nếu trong 6 tháng cuối là D.
- Propranolol: C nếu trong 6 tháng cuối là D.
- Irbesartan và Losartan: C nếu trong 6 tháng cuối là D.
A: These drugs are the safest. Well-designed studies in people show no risks to the B: Studies in animals show no risk to the fetus, and no well-designed studies in
Studies in animals show a risk to the fetus, but well-designed studies in people do
C: No adequate studies in animals or people have been done.
In animal studies, use of the drug resulted in harm to the fetus, but no information
about how the drug affects the human fetus is available.
D: Evidence shows a risk to the human fetus, but benefits of the drug may
outweigh risks in certain situations. For example, the mother may have a life-
threatening disorder or a serious disorder that cannot be treated with safer drugs.
X: Risk to the fetus has been proved to outweigh any possible benefit.
Tham khảo thêm tại: http://www.fda.gov/Drugs/Development./ucm093310.htm
a. Kháng sinh: (tham khảo thêm tại : 1. http://www.healthwikipedia.com/pregnancy/antibiotics-to-avoid-during- pregnancy.html 2. http://www.pregnancybliss.com/antibiotics.html 3. http://www.ncbi.nlm.nih.gov/pubmed/16557603)
- Chloramphenicol : Gray baby syndrome. In women or fetuses with glucose-6-
phosphate dehydrogenase (G6PD) deficiency, the breakdown of red blood cells
b/ Điều trị tăng huyết áp:
- Angiotensin-converting enzyme (ACE) inhibitors: When the drugs are taken late
in pregnancy, kidney damage in the fetus, a reduction in the amount of fluid
around the developing fetus (amniotic fluid), and defects of the face, limbs, and
- Beta-blockers: When some beta-blockers are taken during pregnancy, a slowed
heart rate and low blood sugar level in the fetus and possibly slowed growth
- Thiazide diuretics: A decrease in the levels of oxygen, sodium, and potassium
and in the number of platelets in the fetus's blood. Slowed growth
c/ Kháng nấm: tham khảo tại http://www.aafp.org/afp/2003/0615/p2517.html
Drug name FDA pregnancy risk classification Drug class Crosses placenta? Use in
Butoconazole (Femstat) C Imidazole antifungal Not known Probably safe Clotrimazole (Lotrimin) C Imidazole antifungal Not known Safe in second and
third trimesters (human trials),24 first trimester probably safe23
Miconazole (Monistat) C Imidazole antifungal Not known Probably safe Tioconazole (Vagistat-1) C Imidazole antifungal Not known No data\
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