Drugs used or avoided in pregnancy

drugs used or avoided in pregnancy

1. DRUGS USED OR AVOIDED IN PREGNANCY مقدم من الصيدلى / مصطفى محمد حسنى عثمان دبلوم صيدلة المستشفيات 2015-2016

2. Drugs in pregnancy 1-introduction 2-categorization of drugs during pregnancy 3-examples of drugs used or avoided during pregnancy

3. some important notes to be known about pregnancy A normal pregnancy lasts about 40 weeks . it can be classified to three trimesters: 1-The first trimester lasts from your last period through the 12th week of pregnancy . 2- The second trimester lasts from the 13th week of your pregnancy through the 23rd week. 3-The third trimester lasts from your 24th week of pregnancy until your baby is born to have a healthy pregnancy : Eat healthy foods .   Moderate exercise can help you stay fit. Do not smoke. Do not drink alcohol .   .

4. : How should I decide whether to use a medicine while I am pregnant ? When deciding whether or not to use a medicine in pregnancy, you and your doctor need to talk about the medi­cine's benefits and risks. • Benefits: what are the good things the medicine can do for me and my growing baby (fetus)? • Risks: what are the ways the medi­cine might harm me or my growing baby (fetus)

5. FDA Pregnancy Categories The FDA has established five categories to indicate the potential of a drug to cause birth defects if used during pregnancy. The categories are determined by the risk to benefit ratio. They do not take into account any risks from pharmaceutical agents or their metabolites in breast milk.

6. Category A Adequate and well-controlled 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 ). Example drugs or substances:  levothyroxine ,  folic acid ,  magnesium sulfate ,  liothyronine

7. 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. Exampledrugs :  metformin ,  hydrochlorothiazide ,  amoxicillin ,  pantoprazole , cycl obenzaprine  

8. 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. Exampledrugs :  tramadol ,  gabapentin ,  amlodipine ,  trazodone ,  prednisone

9. 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. Exampledrugs :  lisinopril ,  alprazolam ,  losartan ,  clonazepam ,   lorazepam

10. 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. Exampledrugs :  atorvastatin ,  simvastatin ,  warfarin ,  methotrexate ,  finasteride

11. LEVOTHYROXIN I ndications : thyroid hormone for treatment of hypothyroidism Risk factor : A Fetal risk : · cross placenta in minimal amounts · no available human data but suggested possible association with cardiovascular defects at high doses

12. LANSOPRAZOLE Indication : Proton pump inhibitor, anti- secretory . Risk category : B Fetal risk : · Not  teratogenic  in animals but may cause decreased Fetal weight · In animals long-term, high doses are   carcinogenic · no available data in human pregnancy so it should be avoided

13. METFORMIN I ndication : Oral antihyperglycemic , biguanide Risk category :B Fetal risk : · teratogenic  in animals causing heart, and eye defects and  embryotoxic  at high doses . · No well controlled human data but this drug Does not provide good control of blood sugar in diabetic mothers, so the complications of the disease itself still occur including: structural anomalies, neonatal  hyperviscosity , hyperbilirubinemia ,  polycythemia , and hypoglycemia

14. TRAMADOL I ndication: Centrally acting analgesic, analogue of codein Risk category : C Fetal risk : · Not  teratogenic  in animals but  fetotoxic  at high doses causing decreased fetal weight, skeletal ossification, increased super numerary and transient delay in developmental and behavioral parameters . · Crosses human placenta. · Human data is lacking but when compared with meperidine for labor analgesia, fewer maternal side effects andlower  neonatal respiratory depression had been reported.

15. WARFARIN   I ndication: Oral anticoagulant . Risk category : X Fetal risk: · Certain congenital malformations were associated with warfarin use in the first trimester; including  nasalhypoplasia , stippled epiphyseal calcifications, and central nervous system abonormalities . · Increased incidence of abortion.