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 - Cefotaxim B - Ceftazidime B - Ceftriaxone B - Cefixime B - Imipenem C - Cefepime B - Chloramphenicol C - Ciprofloxacin C - Gentamycin C - Sulfamethoxazole: C nếu gần sinh là D - Tetracycline: D 2. Kháng nấm: - Ketoconazole C - Fluconazole C - Amphotericine B: B 3. Tăng huyết áp: - Methyldopa: B - Nifedipine: C - Hydralazine: C - Perindopril: C nếu trong 6 tháng cuối là D. - Propranolol: C nếu trong 6 tháng cuối là D. - Amlodipine: C - 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 fetus. B: Studies in animals show no risk to the fetus, and no well-designed studies in people have been done. OR Studies in animals show a risk to the fetus, but well-designed studies in people do not. 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 G6PD deficiency, the breakdown of red blood cells - Tetracycline: Slowed bone growth, permanent yellowing of the teeth, and increased susceptibility to cavities in the baby. Occasionally, liver failure in the pregnant woman b/ Điều trị tăng huyết áp: Tham khảo thêm tại http://www.obmed.org/pdfs/hyperten.pdf - 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 lungs - 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 pregnancy 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\ . 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: -. Hydralazine: C - Perindopril: C nếu trong 6 tháng cuối là D. - Propranolol: C nếu trong 6 tháng cuối là D. - Amlodipine: C - Irbesartan và Losartan: C nếu trong 6 tháng cuối là D. A: These. 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