Raising kids raises questions. We have expert answers. So go ahead, ask away!
Reuters reported that U.S. health officials plan to study the safety of medications taken during pregnancy with an eye toward using the data in future regulations and medical practice, the U.S. Food and Drug Administration said on Wednesday.
Citing a lack of clinical trials to determine how medications affect mothers and unborn children, the FDA said it will collaborate with other researchers in the new study, called the Medication Exposure in Pregnancy Risk Evaluation Program.
"Results of these studies will provide valuable information for patients and physicians when making decisions about medication during pregnancy," Gerald Dal Pan, a director at the FDA's Center for Drug Evaluation and Research, said in a statement.
So what does this mean for pregnant women? More importantly: What drugs if any, are pregnant women allowed to take? We asked our resident Parents Ask expert and Obstetrician Dr. Jason A. Rothbart, to break it down:
Dr. Rothbart says: "These studies are all part of the new effort to reclassify drugs' effects on pregnancy, from the classic A,B,C,D,X system (below) to a more comprehensive system that will give more information on the risks vs. benefits and gives practitioners a greater fund of knowledge to individualize decisions based on the drug in question."
For now, the current class system is as follows:
| Pregnancy 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). |
| Pregnancy 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 OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. |
| Pregnancy 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. |
| Pregnancy 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. |
| Pregnancy 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. |
Class "X" is always off limits. The fetal risk clearly outweighs any possible benefits of the drug in question. An example of this is Accutane or Isotretinoin, a strong acne medication. Accutane has been clearly shown to cause birth defects including hearing and visual impairment, missing earlobes, facial dysmorphism, and mental retardation.
There are however class C or D drugs that in most instances would be off limits, but must be individualized per the situation and drug in question. For example, many health care professionals recommend that most pregnant women avoid using aspirin (class D) during pregnancy because of possible bleeding complications.
For women with serious blood clotting disorders, however, the risks associated with leaving the disorder untreated may be far worse than the risks of taking aspirin throughout pregnancy."
Bottom line: Not sure what category/ class to those drugs in your medicine cabinet fall in to? Don't guess. Always consult your doctor before taking anything... especially during pregnancy!
Have questions about what drugs fall into which category? Check HERE for a list of commonly prescribed medicines you CAN take!
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