Place Your Advertisement Here
All ad revenues support the mission of the Epilepsy Therapy Project
 
UPDATED: Sun, 11/11/2007 - 2:45pm

  • Epilepsy First Aid
  • Seizure Medication
  • Videos
  • Seizure Diary
  • Find a Doctor
  • Epilepsy Centers
  • Clinical Trials
  • Event Calendar

Place Your Advertisement Here
All ad revenues support the mission
of the Epilepsy Therapy Project

FDA Pregnancy Categories

Women who are pregnant or considering pregnancy are rightly concerned about whether the medicines they take might cause birth defects or other harm to their developing baby. Doctors are looking for the same kind of information when choosing the best medications to prescribe for young women. In the United States, the Food and Drug Administration (FDA) is one source of guidance. The FDA looks at the evidence available about the risk of harm if each medication is used during pregnancy. Then it assigns each one to a "Pregnancy Category" (A, B, C, D, or X). The category for each medication is reported in its package insert.

Here's a list of the five FDA categories:

     
 

Category

Description

  A Adequate, well-controlled studies in pregnant women have not shown any risk to the fetus in the first three months of pregnancy, and there's no evidence of later risk either. Very few medications have been tested to this level.

  B There have been no adequate, well-controlled studies in women but studies using animals have not found any risk to the fetus, or animal studies have found risk that was not confirmed by adequate studies in pregnant women. Not many adequate studies have been performed in pregnant women, so the first situation (not enough information) usually applies if a medication is assigned to this category.

  C There have been no adequate, well-controlled studies in women, but studies using animals have shown a harmful effect on the fetus, or there haven't been any studies in either women or animals. Caution is advised, but the benefits of the medication may outweigh the potential risks.

  D There is clear evidence of risk to the human fetus, but the benefits may outweigh the risk for pregnant women who have a serious condition that cannot be treated effectively with a safer drug.

  X There is clear evidence that the medication causes abnormalities in the fetus. The risks outweigh any potential benefits for women who are (or may become) pregnant.



This system, while the best now available, could be interpreted as suggesting clear differences between medications in various categories when the differences are really much less distinct. The categorization of many medications is based mainly on lack of evidence one way or the other. The FDA is considering a change to more detailed descriptions that would also include information on fertility and breastfeeding.

Topic Editor:Steven C. Schachter, M.D.
Last Reviewed:10/23/03


Welcome to the Wiki. This space is created for epilepsy.com members to share their own experiences and expertise to help refine and expand the discussion around important topics.

No members have yet contributed to this topic. If you are not yet an epilepsy.com member, register today to get started on this Wiki topic and the many other advantages of being a member. If you are a member and wish to be the first to edit this Wiki topic, please make sure to login, then click on the orange "Start Wiki" button at the top of this page. Or, learn more about Wikis.


Information For Women

Did you know?

Nowhere is the problem more evident than in pregnancy. In the United States, epilepsy affects nearly one million women of childbearing potential. Most women with epilepsy can and do have normal pregnancies however they should follow a few traditional rules for having a healthy pregnancy.

Learn more


Take Control of your seizures by starting My Epilepsy Diary today.

Keeping a daily record of your seizures can help you and your doctor better understand and treat your epilepsy.

Open my epiCom Diary


Title Posted
Seizures During Sleep  
Morning Sunshine
I'm afraid I'll never grow up!  
Newyorkcita
terrified to get pregnant  
linzysmith323
Epilepsy, pregnancy and giving birth  
sonjac1978
Want to get pregnant while on Lamictal  
queente318
Planning Pregnancy Under Lamictal - seeking experiences  
Trichica
On Keppra, Baby on the Way  
rose0527
Want to help, New Dx, weird Dr recommendations  
belimawr
Pregnancy and Trileptal?  
chelsea93
Changing AEDs while pregnant?  
agwalt
View all Forums

Title Posted
Have I had a seizure? Any of these symptoms familiar?  
scotchyscotch
TLE or PNES?  
mel239
Can bacteria be related to seizures?  
larryz
Simple Partial Seizures and EEG/EKG  
erkadrka
NyQuil  
Eilliem
Can taking OTC medications for cold, flu and sinus infections result in seizures?  
larryz
twitchy arm  
emzclarinet
How long do your symptoms last (if they ever even go away)  
jasssmit
Who is your personal hero?  
phylisfjohnson
Causes of Underemployment.  
Matthew Simington
View all Forums

Title Page Views
my.epilepsy.com Updates  
epi_help
topamax and weight loss  
alexia mom
kepra  
brian mattingly
Possible cure for absence seizures  
pdl1
Epilepsy and marijuana  
cjad234
Sexual Side Effects  
George R
How exactly do aura's feel  
WendyBendy
MEDICAL ALERT I.D.'s  
picnupthepcs
Over 40 Different Types Of Seizures - Revised  
spiz
electrical shock in head?  
Maggie
View all Forums

Title Posted
Ohhhhh Baby!  
1sassyhelper
View all Blogs

Title Posted
same dose for 6 years possible unidentified seizures  
mash4077
Well, I know.... (Question at bottom of blog.)  
quesofresco
nightmares  
becky89
i need to vent...  
jacky99
michelle  
michelle41
Etiology of a Housebound Visionary  
tigro65
Anyone w/ temporal lobe epilepsy and not on medication?  
hazel baum
MY 1ST BLOG :)  
awalkingmiracle
I hate the hospital.  
Shenoah
Visit to a doctor - February 2010  
MichaelK
View all Blogs

Title Page Views
Inspirational Quote - My Own Personal Inner Thoughts  
Butterflygrl
my partial complex seizures  
Zanna1211
Topomax... The Dreaded.........  
Dr Jason
Brain Zaps, tics & twitches  
JudiS
side effects of phenobarb.  
pksmom
Feeling Sick  
JBJ1984
How can you tell if a sleep seizure happens?  
epl_controller
Tegretol XR and ANXIETY meds  
Butterflygrl
TYLENOL, AEDs & SEIZURES  
cmscribbles
Nonepileptic "Events" vs. "Seizures"  
teft
View all Blogs

Title Posted
Treating Depression with Epilepsy  
mypetitmal
Burm80  
burm80
WHO NEEDS A SEIZURE ALERT DOG  
MOMMY HOLLIE
surgery group  
bobby chen
Parents of Adult Children with Epilepsy  
askadis
Grandparents of grandchildren with Epilepsy  
EmiliesGrandma
neeraj clinic, rishikesh,india  
ankita gupta
Project Uplift  
tamliniscute
SEIZURE FREE  
gracie9933
EPILEPSY SUPPORT GROUP NORTH CAROLINA  
Roxanne D
View all Groups

Title Posted
It's okay to have babies  
jansy
Isolated Seizures, Don't feel the need for Meds...  
luli18
What happened?  
andi78
View all Stories

Title Posted
Do I really have seizures?  
Elmwoody
Looking for answers...  
BSimons
Finding myself through the years  
starlitgemini
Too many times doing the fish!!!  
Jeffrey Resetar
My First story  
eggcoo
my beautiful 6yr old boy  
kaiden
My son has Rolandic Epilepsy  
klabiche
My mother's epilepsy  
Raymond Loh
A married man with a sick wife  
russell11
Many changes I had and continue to have.  
Its Me
View all Stories

Place Your Advertisement Here
All ad revenues support the mission
of the Epilepsy Therapy Project