DRUGS USED OR AVOIDED IN PREGNANCY

الصيدلى / من عثمان مقدم حسنى محمد مصطفى

المستشفيات صيدلة 2016-2015دبلوم

Drugs in pregnancy1-introduction

2-categorization of drugs during pregnancy

3-examples of drugs used or avoided during pregnancy

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. .

: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 medi cine'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 medi cine

might harm me or my growing baby (fetus)

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 .

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

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

 

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

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

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

LEVOTHYROXIN

Indications: thyroid hormone for treatment of hypothyroidismRisk factor: A Fetal risk : · cross placenta in minimal amounts · no available human data

but suggested possible association with

cardiovascular defects at high doses

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

METFORMINIndication: 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

TRAMADOLIndication: Centrally acting analgesic, analogue of codeinRisk 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.

WARFARIN 

Indication: 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 .