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 risk.
- 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 expanded the lettering system in 2015, with a goal of eventually removing 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 focus 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.
We advise all of our surrogates to check with their OB about any drugs, including both over the counter medications and prescriptions, before taking them. It’s important that you remember that surrogates in our program were chosen for their maturity and solid decision-making abilities. Trust that she won’t put herself or your baby in danger. But, of course, if you have any concerns you can feel free to reach out to your case manager.