If you are considering becoming pregnant of if you are pregnant, talk with Genesis Women’s Health Services before you take any medications, including OTC (over the counter), prescription, supplements, or herbal supplements.
According to the U.S. Food and Drug Administration (FDA), less than 10% of all medication approved by FDA since the early 1980s have enough information to determine whether or not the medicine is a risk of causing birth defects or not.
Pregnancy Categories for Medications
The FDA categorizes pregnancy medications into five sections, each of which provides critical research information that is then used to decide whether a pregnant woman should or should not take the medication, knowing that it may or may not be harmful to her unborn baby.
Satisfactory and well-controlled studies that failed to exhibit a risk to the unborn baby in the first trimester of pregnancy fall into this category (with no evidence of any risk in the second and third trimesters).
Animal studies have failed to prove any risk to a human or animal fetus, and there are no satisfactory and well-controlled studies in pregnant women.
Animal studies have shown a negative effect on the fetus, and there are no satisfactory and well-controlled studies in humans. However, potential benefits may permit use of the medication in pregnant women regardless of potential risks.
There is positive proof of human fetal risk based on data from investigations or experience, but probable benefits may permit use of the medications in pregnant women in spite of potential risks.
Studies in animals and humans have confirmed fetal abnormalities and/or there is affirmative evidence of human fetal risk based on the adverse reaction data from investigations or experience. The risks clearly outweigh any benefit of using this category of medications. Category X medicines should never be used by pregnant women!
You should always talk to Genesis Women’s Health Services if you are considering taking any medication or supplements during your pregnancy. Never just assume it is okay to take medication or supplements that can potentially have horrible effects on your unborn baby. Be safe instead of sorry and always ask first!