FDA Categories for Medication Use in Pregnancy f. A controlled studies in women fail to oi: demonstrate fetal risk during first trimester oE fetal harm is remote 百· B either: Animal studies do not indicate risk to fetus and o000oc0= there are no controlled studies in human women OR studies failed to demonstrate rl- but human Animal studies have indicated risk KENTUCKY (::Yaffe SJ. Drugs in pregnancy and lactation.2005: 7: xii-xix College of Pharmacy
FDA Categories for Medication Use in Pregnancy • A controlled studies in women fail to demonstrate fetal risk during first trimester; fetal harm is remote • B either: – Animal studies do not indicate risk to fetus and there are no controlled studies in human women OR – Animal studies have indicated risk, but human studies failed to demonstrate risk Yaffe SJ. Drugs in pregnancy and lactation. 2005;7: xiii-xix
Eab FDA Categories for Medication Use in Pregnancy o Either OE:,. Animal studies demonstrate fetal risk and there are no controlled studies in human women OR e No animal studies have been conducted and there o000oc0= are no controlled studies in pregnant women D positive evidence of fetal risk however there may be certain situations where benefits outweigh risks X definite fetal risk and risk outweighs any benefit in pregnant women(CONTRAINDICATEDy KENTUCKY Yaffe SJ. Drugs in pregnancy and lactation. 2005; 7: xiii-xix College of Pharmacy
FDA Categories for Medication Use in Pregnancy C either Animal studies demonstrate fetal risk and there are no controlled studies in human women OR No animal studies have been conducted and there are no controlled studies in pregnant women Dpositive evidence of fetal risk, however there may be certain situations where benefits outweigh risks Xdefinite fetal risk and risk outweighs any benefit in pregnant women (CONTRAINDICATED) Yaffe SJ. Drugs in pregnancy and lactation. 2005;7: xiii-xix
23. Problems with Current System 6 Less than 1% of medication have category a' rating Greater than 65% of medications have category ' c 00 rating Current categories are outdated and difficult to understand a.. Single letter cannot adequately summarize clinical information and summarize scientific data Inconsistent with current information 2.o Increase ability to make well-informed decision KENTUCKY College of Pharmacy
Problems with Current System • Less than 1% of medication have category ‘A’ rating • Greater than 65% of medications have category ‘C’ rating • Current categories are outdated and difficult to understand • Single letter cannot adequately summarize clinical information and summarize scientific data • Inconsistent with current information • Increase ability to make well-informed decision
Eda Proposed FDa Changes a.y. Elimination of current A, B, C, D, X categories oE: Elimination of labor and delivery subsection 0=0000000= oi. Development of new"pregnancy'and lactation 'subsections 3 main components of each subsection ° Risk summary Clinical considerations Data section KENTUCKY http://www.regulations.gov/#!documentdetail;D=fda-2006-n-0515-0001 College of Pharmacy
Proposed FDA Changes • Elimination of current A,B,C,D, X categories • Elimination of labor and delivery subsection • Development of new ‘pregnancy’ and ‘lactation’ subsections – 3 main components of each subsection • Risk summary • Clinical considerations • Data section http://www.regulations.gov/#!documentDetail;D=FDA-2006-N-0515-0001
Eab Pregnancy Subsection Risk summary One sentence summary of risk that the medication may or may not increase likelihood of various fetal abnormalities 00 Clinical considerations Prescribing considerations (ex: dose adjustments, unique ADR during pregnancy, complications in neonates, etc Medication effects during labor and delivery o000oc0= Inadvertent exposure Supporting data Study type Dose exposure information Nature of fetal abnormalities and adr Data from pregnancy exposure registries KENTUCKY http://www.regulations.gov/#!documentdetail;D=fda-2006-n-0515-0001 College of Pharmacy
Pregnancy Subsection • Risk summary – One sentence summary of risk that the medication may or may not increase likelihood of various fetal abnormalities • Clinical considerations – Prescribing considerations (ex: dose adjustments, unique ADR during pregnancy, complications in neonates, etc) – Medication effects during labor and delivery – Inadvertent exposure • Supporting data – Study type – Dose exposure information – Nature of fetal abnormalities and ADR – Data from pregnancy exposure registries http://www.regulations.gov/#!documentDetail;D=FDA-2006-N-0515-0001