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:
- Kháng sinh
- Kháng nấm
- Điều trị tăng huyết áp
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
evidence of risk in later trimesters).
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
in any trimester.
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
despite potential risks.
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
despite potential risks.
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:
1. Kháng sinh:
- Amoxicilline B
- Ampicillin B
- Cefuroxime B


C: No adequate studies in animals or people have been done.
OR
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
1 số thuốc:
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

- Fluoroquinolones (such as ciprofloxacin , ofloxacin , levofloxacin , and
norfloxacin ): Possibility of joint abnormalities (seen only in animals)

- Kanamycin: Damage to the fetus's ear, resulting in deafness

- Nitrofurantoin : In women or fetuses with G6PD deficiency, the breakdown of
red blood cells

- Sulfonamides (such as sulfasalazine and trimethoprim- sulfamethoxazole ):
When the drugs are given late in pregnancy, jaundice and possibly brain damage
in the newborn (much less likely with sulfasalazine). In women or fetuses with