Explaining The FDA’s Medication Grading For Pregnant Women
It is never much fun to be sick, but to come down with a cold while you’re pregnant is downright frustrating. Apart from feeling poorly, your options for over the counter treatment are limited. Here’s a look at how the FDA classifies different drugs during pregnancy.
Since 1979, the Food and Drug Administration (FDA) has classified medications into five main categories for pregnant women. The FDA lumps most drugs into a class A, B, C, D or X category. Categories are meant to explain potential risks of a drug as opposed to issuing a blanket “yes” or “no” as to whether or not it should be taken during pregnancy.
The headings are:
- Category A
- Well controlled studies have been completed on these drugs.
- Studies failed to show any risks to a fetus in 1st, 2nd, or 3rd trimesters of pregnancy.
- Examples include: folic acid, Levothyroxine.
- Category B
- Studies on animal groups have failed to show any ill effects on a fetus in 1st, 2nd, or 3rd trimesters of pregnancy.
- No adequate or well-controlled studies have been completed on human subjects.
- Examples include Metformin, Penicillin, Amoxicillin, Benadryl, Tylenol, Dramamine, Zantac, Unisom, Claritin.
- Category C
- Studies of pregnant animals have shown adverse effects on pregnancy or fetal development
- No adequate or well-controlled studies have been completed on humans.
- Generally, these drugs are only advised for treatment if potential benefits outweigh potential risks.
- Examples include: Mucinex, Robitussin, Imodium, Tums, Gasx, Sudafed, Chlor-Trimenton, Monistat 1.
- Category D
- Positive evidence of danger or fetal risk has been confirmed in human pregnancy.
- Potential benefits from this class of drug may outweigh the potential
- Examples include: Xanax, Paxil, Topamax, Advil, Motrin, Aleve (After 30th-week gestation, Class C prior).
- Category X
- These drugs have positive evidence of fetal risk and demonstrated abnormalities at birth.
- Risks involved with these medications are deemed too serious to warrant the benefit gained from use.
- These drugs should not be used in pregnancy.
- Examples include: Coumadin, Trexall, Danazol, Sotret.
The FDA lettering system was expanded in 2015, but the initial goal was to eventually discontinue the lettering system altogether. This explains why some newer medications may not carry a letter designation. Eventually, the FDA will phase out the lettering system and replace it with these titles:
- Pregnancy (through labor and delivery)
- Female & Male Reproductive Potential
The new plan will centralize on a narrative as opposed to a generic letter grade. The pregnancy and lactation headings will include information on dosing and potential risks if taken during these phases of life. The female and male reproductive potential category will talk about potential implications on the reproductive health of a certain drug.
If you have any doubts about a certain drug, either the counter medication or prescription, always check with your OB before taking the drug. The internet is a quick and easy resource, but it’s not always accurate. Likewise, just because another pregnant woman says she took a certain medication during her pregnancy with no ill effects, it does not mean that you can or should do the same. Many things can impact how our bodies react to sickness, injury, and medication. So, if you have questions, call your doctor for guidance.