FDA Drug Category Ratings
In 1975, the FDA created guidelines for drug companies to follow in regards to labeling medications about their affects on reproduction and pregnancy.
Since then, FDA has realized that although this method is a great base, it can lead to confusion and the belief that using a drug during pregnancy is a black and white issue. In 1997, the FDA began the work of revamping the drug labeling system by replacing the letter categories with more descriptive and detailed information.
Until the new system comes out, women and health care providers have to do the best they can in evaluating all the options in regards to medication use during pregnancy. The FDA chart is a great starting place, but pregnant women should be well informed on the different choices of medication and any alternative therapies.
FDA Use-in-Pregnancy Ratings
| Category | Description |
|---|---|
A |
Controlled studies show no risk-Adequate, well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester of pregnancy. |
B |
No evidence of risk in humans-Adequate, well controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or In the absence of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote, but remains a possibility. |
C |
Risk can not be ruled out- Adequate, well-controlled human studies are lacking, and animal studies have shown a risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is administered during pregnancy; but the potential benefits may outweigh the potential risk. |
D |
Positive evidence of Risk-Studies in humans, or investigational or post marketing data, have demonstrated fetal risk. Nevertheless, potential benefits from the use of the drug may outweigh the potential risk. For example, the drug may be acceptable if needed in a life threatening situation or serious disease for which safer drugs cannot be used or are ineffective. |
X |
Contraindicated in Pregnancy- Studies in animals or humans, or investigational or post-marketing reports, have demonstrated positive evidence of fetal abnormalities or risk which clearly outweighs any possible benefit to the patient. |
For more information on the FDA drug rating system, see the FDA Consumer Magazine or the FDA web site.