Degree of Teratogenicity

مجهول

susceptability to teratogen from species to another due to different behavior in absorption , distribution & metabolism

FDA Pregnancy categories

The drugs are classified into number of categories as following :
A ( the most safe ) -->B-->C-->D-->x(the most teratogenic) i

CLASS A

Degree of teratogenicity

Adequate & well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy ( & there is no evidence of risk in later trimester ) .i

example

folic acid , thyroid hormones


CLASS B

Degree of terratogenicity

animal reproduction studies have failed to demonstrate a risk to the fetus & there are no adequate & well-controlled studies in pregnant women

example

[align=left]paracetamol , erythromycin , cephalosporines & penicillin
[/align]


CLASS C

Degree of teratogenicity

animal reproduction studies have shown an adverse effect on the fetus & there are no adequate & well controlled studies in human , But potential benefits may warrant use of the drug in pregnant woman despite potential risks

( drugs of category C has Benefits > Risks )i

example

heparin , ketoconazole , NSAIDS , acyclovir , labetalol , nifedipine , ACEI


CLASS D

Dgree of teratogenicity

there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studien in human , but potential benefits may warrant use of the drug in pregnant woman despite potential risks

if the drug is needed in a life-threatning situation or for a serious disease for which safer drugs cannot be used or ineffective

example

tetracycline , only used for life saving , glyburide , diazepam , aspirin


CLASS X

Degree of teratogenicity

studies in animal or humans have demonstrated fetal abnormalities & \or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience , & the risk involved in the use of the drug in pregnant woman clearly outweigh potential benefits

example

cytotoxic drugs , thalidomide , warfarin , isotrirntoin , oral contraceptive , lovastatin

Dr.Ahmad

شكرا دكتورة موضوع شامل رغم أنه غير طويل

هيك رح نصير نفهم شو يعني درجات التشوه بشكل أفضل

مجهول

شكرا دكتور احمد بتمنى اكون قدرت انى اوصل المعلومه