“Case . Example” ●Patient: XX, female, 28 years old, pneumonia (self pregnant) ● Medication: ciprofloxacin lactate sodium chloride injection 0.2g, intravenous infusion, 0.2g/time for 7 days. ●After getting well, it was found that relatives (menstruation) did not come, and it was confirmed by examination that she was pregnant. After reviewing the instructions, the patient learned that ciprofloxacin will affect fetal cartilage development, and pregnant women are prohibited! ●Q: If I don’t know that I am pregnant, I take a drug that is contraindicated by pregnant women. Will the child stay or not? Proven human teratogenic drugs ●Many drugs are related to fetal abnormalities, but only a part of the drug cases are deformed. The table below lists drugs that have been shown to have teratogenic effects on humans. Teratogenic sensitive period of human embryo development ●After egg fertilization, the development of embryo and fetus is divided into three stages: insensitive period, sensitive period and low sensitivity period. ◆Insensitive period (early embryo): 14~28 days after the last menstruation, that is, 0~2 weeks of pregnancy. △In this period, the effect of the drug on the embryo is “all or nothing”: either the embryo dies (abortion) due to the lethal dose of the drug, or the fetus is not affected by the drug, which generally does not cause fetal malformation. ◆Sensitive period (embryo stage): 29 days to 70 days after the last menstrual period, that is, 3-8 weeks of pregnancy. △ This period belongs to the period of fetal organ differentiation, such as the central nervous system (brain), circulatory system (heart), sensory system (eyes, ears), musculoskeletal system (limbs), etc. During this period, embryos are the most sensitive to drugs and prone to severe deformities. ◆Low sensitivity period (fetal period): 9-38 weeks of pregnancy (11-40 weeks of pregnancy). △ This period belongs to the period of occurrence and functional maturity of most organizations. The effects of drugs may involve growth and function, such as mental development and reproductive function. Three Elements of Drug Risk Assessment in Pregnancy ● When conducting a risk assessment during pregnancy, you need to know at least the following three questions. ◆How long has it been since the last menstruation? △ The pregnant woman’s medication time from the last menstrual period: 23 days to 29 days. ◆How long is the normal menstrual cycle? △The patient’s menstrual cycle is 28 days, and it is relatively regular. Usually, women ovulate 14 days after the last menstruation. ◆The nature of the drug (the effect of the drug on the fetus)? △ Ciprofloxacin (quinolone antibacterial drugs) can pass through the placental barrier. The US Food and Drug Administration (FDA) has a pregnancy safety rating of C. △ Disabled during pregnancy! Pregnant women risk assessment ●The last medication time is in the insensitive period, sensitive period, and low sensitivity period (9-38 weeks of pregnancy?) ◆This pregnant woman is special, and the medication period is 23 days to 29 days after the last menstruation. The last medication was taken on the 29th day after the last menstruation, which crossed the 28-day relative safety period. ●Half-life, reproductive toxicity, toxic target organs of taking drugs? ◆ Half-life △The half-life of ciprofloxacin is about 4-6 hours. In other words, after 6 half-lives (24 to 36 hours, about 2 days), ciprofloxacin is basically eliminated by 99%. △ The pregnant woman’s last medication was on the 29th day after the last menstruation, that is, the pregnant woman was actually exposed to ciprofloxacin for 31 days (29 days + 2 days). ◆Reproductive toxicity△ Animal experiments have not confirmed that quinolones have teratogenic effects. △ A cohort study of 57 women using quinolone drugs and 17,259 control women did not find an increased risk of congenital abnormalities. ◆Toxic target organs△ Although animal experiments have not confirmed that quinolones have teratogenic effects, they can cause joint disease in juvenile animals. After the fertilized egg is formed, the musculoskeletal system starts to develop within 4.33 to 7 weeks of pregnancy (38-63 days after the last menstrual period). (See the table below) The pregnant woman was exposed to ciprofloxacin for 31 days, which is still 7 days away from 38 days. Therefore, it can be judged that since ciprofloxacin has been eliminated in the body, the impact on the fetus will be relatively small, or even no. Evaluation recommendations ● From the perspective of pharmacy, according to the above medication time calculation, after the drug is cleared, the fetus has not yet begun to develop bones and can continue pregnancy, but if there is a risk of miscarriage or bleeding, do not protect the baby. Tips ●Women of childbearing age who have not taken contraception during sex life are using antiviral drugs (ribavirin), quinolones antibacterial drugs (levofloxacin, ciprofloxacin, moxifloxacin, etc.), aminoglycoside antibacterial drugs ( Before amikacin, gentamicin, etc.) and tetracycline antibiotics (minocycline, etc.), a pregnancy test is recommended!