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June 4, 2009

In The News - Understanding the Risks (and Rewards) of Pills and Pregnancy


My husband reads Time Magazine and thought sharing this article with my Mommy Vomitpants readers would be a good idea. After checking it out, I have to agree!!

Having been pregnant, I can attest to the desire, at times, to pop a pill to fix what may be ailing you. But, it's important to remember that your body is no longer your own when you are pregnant. Everything you ingest is ingested by your baby. Believe it or not, even over the counter drugs can be harmful to your unborn baby. It can be hard for a first-time mother to know what is safe to take and what is not. I mean, let's face it, we live in a "pill-popping" society. People just "pop a pill" when they have indigestion or a headache or allergies without thinking twice about what they are putting into their bodies.

That's why it's so important when you are pregnant to be very diligent about what you are taking. And it's important to talk to your doctor if you have ANY questions about a medication. Often times, if your doctor is unavailable, you can ask to speak to a nurse. If you happen to be at the pharmacy or grocery store, a pharmacist can help you as well.

So, how do you know which category your medication fits into? And, how do they determine that anyway? Here is where the Article Understanding the Risks (and Rewards) of Pills and Pregnancy comes into play (click the title to read the article).

To sum up the article, the medical community sees a need for clinical research on drugs and pregnant women. However, red flags go up when you talk about clinical trials on pregnant women (as they should). All that aside, we are a far cry from the "olden days" (as recently as 20 years ago) when they would perform trials on men and "extrapolate" the results to women. No, I am not kidding.

But when you have chronic illness like depression, diabetes, and hypertension, what is a pregnant woman to do? What if you have cancer? Did you know there are only about a dozen medications that are approved by the FDA for use by pregnant women? And when you agree to take a drug that could pose a risk to your unborn fetus, you may be required to sign a release form to exempt your doctor from prosecution should something bad happen.

The National Institutes of Health (NIH) is currently funding a National Children's Study, which is enrolling 100,000 women who are either pregnant or plan to become pregnant, with the goal of tracking the development of the children from preconception to adulthood. While that is ongoing, the FDA had proposed overhauling the guidance it gives on drug use by pregnant women.

Right now, the Food and Drug Administration (FDA) classifies pills and their effects on pregnancy into 5 different "categories". Let's take a look at each of them.
  • Category A pills are safe for ingestion by a pregnant woman. This category of pill has had extensive testing done by the FDA and do not show an increase in birth defects after use.

  • Category B pills can be safe, but you should ask your doctor to be sure. This category of pill has either had extensive animal testing (showing no increase in defects) but no well-done human trials have been conducted, or animal studies suggested birth defects where human trials did not.

  • Category C pills are generally not safe to use. This category of pills had animal testing show increased birth defects (with no large, well-done human trials), or there are no good animal or human studies BUT the benefits of the drug can outweigh the risks associated with taking it.

  • Category D pills are generally not safe to use but the risks can outweigh the benefits of taking the medication. This category of pills do show an increased risk of birth defects with use.

  • Category X pills should not be used. This category of pills showed an increased risk of birth defects with the benefits of taking the medication NOT outweighing the risks to the baby.
Since the above categories are so broadly defined, as they currently stand, they are looking into providing a more narrative, evidence-based summary about each individual drug and the effect it has on pregnant and nursing women.

Hopefully, the NIH study coupled with the FDA redefinition of drugs, and the "Second Wave" of clinical research mentioned in the article will help the pregnant women of the future to make better decisions when it comes to medication and their unborn baby. Until then, please talk to you doctor about ALL medications that you take and ask about the risks to your unborn baby. The same goes for breastfeeding mothers. Please don't make an uneducated decision.



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