Close Menu
Healthtost
  • News
  • Mental Health
  • Men’s Health
  • Women’s Health
  • Skin Care
  • Sexual Health
  • Pregnancy
  • Nutrition
  • Fitness
What's Hot

Here’s the ACA Premium hikes

July 24, 2025

Prostate cancer and erectile dysfunction

July 24, 2025

Bicarb, magnesium and search for perfect Pit formula

July 24, 2025
Facebook X (Twitter) Instagram
  • About Us
  • Contact Us
  • Privacy Policy
  • Terms and Conditions
  • Disclaimer
Facebook X (Twitter) Instagram
Healthtost
SUBSCRIBE
  • News

    Here’s the ACA Premium hikes

    July 24, 2025

    Coverage exceeds opponents in timely detection of covid mutations

    July 24, 2025

    Forever Chemicals Cross Placenta and breast milk that affect baby immunity

    July 23, 2025

    Targeting of tumor cell stem can keep the key to treating colon cancer more effectively

    July 23, 2025

    Aging skin buckles under pressure leading to wrinkles

    July 22, 2025
  • Mental Health

    How mothers who support mothers can help cover the lack of healthcare and other barriers to care

    July 22, 2025

    Do you have to trust a AI mental health application? -Poic details, privacy risks and 7 -point security checklist

    July 19, 2025

    3 ways Canadians can take control of their finances in a time of economic uncertainty

    July 18, 2025

    Exercise can significantly benefit the mental health of adolescents – here they say the items

    July 13, 2025

    Awareness Month for Mental Health 2025: Turn awareness into action

    July 9, 2025
  • Men’s Health

    Prostate cancer and erectile dysfunction

    July 24, 2025

    30 minutes of full body workout to burn fat and enhance strength

    July 23, 2025

    Erythritol changes brain function and may increase the risk of stroke

    July 21, 2025

    Cardio vs. Training Power: Which is better for shrinking medium -age fat?

    July 21, 2025

    New peak health technologies for all men over 40

    July 20, 2025
  • Women’s Health

    How do you treat the vagina? Effective, non-relief-Vuvatech, non-surgical options

    July 24, 2025

    Probiotics of Multiple Executives for Bowel, Skin and Energy Support

    July 23, 2025

    Power beyond the game: Vicky Fleetwood

    July 22, 2025

    Can you get magnesium with multivitamins and other vitamins?

    July 21, 2025

    I wasn’t tired. I was in heart failure.

    July 20, 2025
  • Skin Care

    Bicarb, magnesium and search for perfect Pit formula

    July 24, 2025

    All thermal flx | About aesthetics

    July 24, 2025

    The bridal flash guide with Joanna Vargas

    July 22, 2025

    Think that your sunscreen protects you? New study probably says no

    July 21, 2025

    Your Guide to Resources: both large and small

    July 20, 2025
  • Sexual Health

    How to try HIV in Australia: Free, Fast and Private

    July 21, 2025

    Do orgasms change over time?

    July 21, 2025

    7 gender myths collapsing by a special fertility for couples

    July 19, 2025

    New Jersey’s ban on book bans

    July 18, 2025

    I’m Trans Teen. The US government is attacking my community.

    July 18, 2025
  • Pregnancy

    67 Perfect Baby Book Inscriptions

    July 24, 2025

    Restore your week with these Storms-Rose Stork

    July 22, 2025

    Why French baby names tend to modern mothers

    July 21, 2025

    Last minute baby gifts that still join each mom

    July 17, 2025

    How to avoid activation and manage it?

    July 16, 2025
  • Nutrition

    45 Vegetable Summer Picnic Recipes

    July 23, 2025

    Episode 007: The Power of Critical Thinking: Why Success requires Brave Options with Sean Croxton

    July 22, 2025

    Do you need a glucose screen if you don’t have diabetes?

    July 22, 2025

    Do you have a dessert? Here is 5 natural GLP-1 foods for dessert

    July 21, 2025

    Grammie + Pea Camp 2025 • Kath eats

    July 20, 2025
  • Fitness

    Jacksonville Hiking Trails: Fresh Air & Fun for all

    July 23, 2025

    My healthy stack of sleep: what I use for deep, restorative rest

    July 23, 2025

    New Dumbbell training for beginners (plus my favorite exercises 💪)

    July 22, 2025

    10 healthy ways to launch steam

    July 22, 2025

    10 high -protein breakfast ideas for weight loss

    July 21, 2025
Healthtost
Home»Pregnancy»FDA Pregnancy Risk Categories: Leaving for Good
Pregnancy

FDA Pregnancy Risk Categories: Leaving for Good

healthtostBy healthtostJanuary 19, 2025No Comments5 Mins Read
Facebook Twitter Pinterest LinkedIn Tumblr Reddit WhatsApp Email
Fda Pregnancy Risk Categories: Leaving For Good
Share
Facebook Twitter LinkedIn Pinterest WhatsApp Email

By Lynn Martinez and Julia Robertson, CPM

In the more than 40 years that MotherToBaby affiliates have been serving the public with education about exposures during pregnancy, many women have called in very distressed, sometimes in tears, to discover they were pregnant while taking a drug categorized as X or D the Food and Drug Administration (FDA) system. “I was on birth control pills and still got pregnant! Does this mean my baby will have birth defects? It’s class X drug for good!’ This kind of hysterical reaction was, unfortunately, a common appeal. It was not uncommon to hear that some of these women had considered terminating otherwise desirable pregnancies. The FDA realized that these pregnancy categories weren’t as useful as they wanted and stopped using them in 2014, about ten years ago. They now use the Pregnancy and Lactation Labeling Rule (PLLR) which has a drug narrative summary, similar to what you’ll find here on MotherToBaby.

But first, a little background…

For decades the FDA has been aware of significant problems with the system used to categorize drugs for use in pregnancy. In 1992, the Teratology Society (now known as the Society for Birth Defects Research and Prevention), an interdisciplinary group of scientists who study birth defects, raised concerns and noted that the Category or “CAT” system led to unnecessary terminations of desired pregnancies1. The FDA’s Pregnancy Labeling Initiative recommended eliminating the CAT system, changing the label to include more descriptive risk statements, and requiring drug inserts to be updated when human information is known.

Before the labeling rule changed, when a drug was approved for sale in the U.S., it had to be labeled with one of five pregnancy GATs: A, B, C, D, or X. A meant the drug was well studied and did not pose a threat to a developing baby; B was a less studied but probably still low-risk drug. C was an unstudied drug and therefore the risk was unknown. a class D drug, based on animal or human data, may have posed a risk; and classification X meant that the drug, based on animal or human data, caused birth defects or there was no benefit from its use during of pregnancy. Its use is not recommended during pregnancy.

More than 90 percent of new drugs were categorized as CAT C, D or X, with the vast majority being C. Drug manufacturers were legally required to update the category if harmful effects were reported. However, there was no such requirement to inform the category when the studies showed no problems in pregnancy. Most drugs on the market in 2014 were classified as CAT C, when in fact the majority should have been labeled as CAT A or B. Manufacturers knew that regardless of a woman’s history, all pregnancies carry a 3 percent risk of stillbirth with a serious genetic defect. Because of this, many manufacturers may have felt better protected from lawsuits if their drugs were listed as CAT C, D, or X. So, really, why move drugs in those categories to A or B? They really had no motivation.

Moving forward and what it means for mom…

With the FDA rule change in 2014, a new set of requirements was put into place to better inform mom. It now requires manufacturers to “update” a drug’s labeling when studies show the risk has changed. Also, manufacturers should explore different ways to discuss in detail the risks associated with the drug. One resource of experts that manufacturers could consult is a teratogen information service such as MotherToBaby. More information will help you make more informed choices about your health and pregnancy!

There will still be confusion…

As we see the new labels implemented, there will still be many drugs on the market with the CAT system as it will take time to update them all. MotherToBaby does not recommend that the public or providers rely on the old CAT system for risk assessment. We welcome your questions about the system as well as questions about specific drugs in pregnancy and breastfeeding for a complete, individualized risk assessment. Call us TOLL FREE at 866-626-6847.

Lynn Martinez is a retired Teratogen Information Specialist. Lynn has traveled Utah training physicians, nurse midwives, pharmacists and others for the past three decades.

Julia Robertson, CPM, now retired, works part-time overseeing quality control efforts for MotherToBaby. In her 25-year career as a teratogen information specialist, she authored several peer-reviewed publications focusing on maternal drug consumption and the effect on the developing fetus.

MotherToBaby is a service of the International Organization for Special Teratology Information (OTIS), a recommended resource by many agencies, including the Centers for Disease Control and Prevention (CDC). If you have questions about medications, alcohol, diseases, vaccines, or other exposures during pregnancy or breastfeeding, call MotherToBaby TOLL FREE at 866-626-6847 or visit a library newsletters.

  1. Friedman, J. Teratology 1993:48:506
  2. For more information go to:

Categories FDA Good Leaving Pregnancy risk
bhanuprakash.cg
healthtost
  • Website

Related Posts

67 Perfect Baby Book Inscriptions

July 24, 2025

Restore your week with these Storms-Rose Stork

July 22, 2025

Erythritol changes brain function and may increase the risk of stroke

July 21, 2025

Leave A Reply Cancel Reply

Don't Miss
News

Here’s the ACA Premium hikes

By healthtostJuly 24, 20250

The host Julie Rovner Kff Health News @Jrovner @julierovner.bsky.social Julie Rovner is the head of…

Prostate cancer and erectile dysfunction

July 24, 2025

Bicarb, magnesium and search for perfect Pit formula

July 24, 2025

67 Perfect Baby Book Inscriptions

July 24, 2025
Stay In Touch
  • Facebook
  • Twitter
  • Pinterest
  • Instagram
  • YouTube
  • Vimeo
TAGS
Baby benefits body brain cancer care Day Diet disease exercise finds Fitness food Guide health healthy heart Improve Life Loss Men mental Natural Nutrition Patients Pregnancy protein research reveals Review risk routine sex sexual Skin study Therapy Tips Top Training Treatment ways weight women Workout
About Us
About Us

Welcome to HealthTost, your trusted source for breaking health news, expert insights, and wellness inspiration. At HealthTost, we are committed to delivering accurate, timely, and empowering information to help you make informed decisions about your health and well-being.

Latest Articles

Here’s the ACA Premium hikes

July 24, 2025

Prostate cancer and erectile dysfunction

July 24, 2025

Bicarb, magnesium and search for perfect Pit formula

July 24, 2025
New Comments
    Facebook X (Twitter) Instagram Pinterest
    • About Us
    • Contact Us
    • Privacy Policy
    • Terms and Conditions
    • Disclaimer
    © 2025 HealthTost. All Rights Reserved.

    Type above and press Enter to search. Press Esc to cancel.