What do FDA Pregnancy Ratings Mean?

So you guys know about the Food and Drug Administration, right? It’s the American agency that’s responsible for protecting and promoting public health and one of their main jobs is to oversee the production and safety of drugs and medications. They are the folks who slap those handy warnings on cigarettes and alcohol.

You knocked up gals get your own, special FDA rating system for your over-the-counter and prescription drugs. This rating system has five categories that indicate the potential a drug may have to cause fetal birth defects if taken while pregnant.

These categories do not apply to breastmilk and nursing moms, just FYI.

The categories are:

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: Folic Acid

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. Examples: Acetaminophen (Tylenol), Amoxicillin

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. Examples: Coedine, Zoloft,

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. Example: Valium, Xanax

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. Examples: Accutane, Lipitor

Category N

FDA has not classified the drug.

If you read through these descriptions you can see that the FDA is carefully weighing the pros and cons of the potential for fetal birth defects against the potential harm to the mother if she doesn’t get her needed medication.

As far as I can tell there are two clear categories here. Category A translates to: ‘Go take your pills! You and baby both get to be happy!’ And Category X seems to indicate ‘The risk of birth defects with his drug is so high, it is totally not worth it. Just don’t take it.’ I can only assume they chose ‘X’ (instead of ‘E’) for this category to illustrate a significant separation from the other categories, and because ‘Fuck No’ would be too long.

The tricky part seems to be all the categories in the middle. Some of these drugs caused birth defects in animals but can’t ethically be tested on pregnant women – “could you swallow this pillow case of Zoloft in your third trimester and tell us what happens?”. Some of these drugs are risky in the first trimester and seem to have less risk of being harmful later in the pregnancy. Some of these drugs didn’t cause much harm if taken infrequently but risk increased with added exposure.

FDA-chart

If you want to track down any medication you’re currently or thinking about taking you can try here, here and here. I’ll warn you though, these pages are designed like a basement bingo hall and category listings aren’t always easy to find. In all fairness, they are most likely trying to make your doctor or pharmacist your go-to so a medication isn’t getting a thumbs up without the whole picture – what may be safe for you may not be safe for someone else.

You get the gist. Bottom line is: talk to your doctor about the safety of any drugs you have to take while pregnant – you never know what will make rats glow this month.

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2 Comments

  • Ask your doctor, but also do your own research. I’ve had a pretty awful time dealing with doctors acting on 30yr old studies that have been proven false in more recent research. I understand the ethical dilemma, but it’s also super difficult to make informed risk/benefit analysis with little to no actual information.

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