Pregnant Guinea Pigs: Would You Take Unapproved Drugs?

Amy Kuras

pregnant silhouetteBoth times I've been pregnant, I caught well and truly awful colds. We're talking stuffy nose, raging headache, sore throat, and bone-rattling cough (yay for winter babies!).

Both times, I had to carefully weigh whether taking anything to alleviate my symptoms was advisable. I'm drug-averse when I have only myself to worry about; when gestating my children, I really had to be miserable to even consider taking something.

And the fact is my OB and the nurses that worked with him, who served as wonderful guides in every other way, were almost completely unhelpful here. Dr. Google would tell me one thing, they'd tell me another, and the product label still another.

Unfortunately, there's not nearly enough known about the safety and effectiveness of drugs in pregnant women because very few studies have been done to evaluate them.

Beyond the obvious worry of being sued into oblivion if a drug deemed to be safe harms so much as a hair on a baby's head, drug manufacturers would probably have a fairly difficult time gathering pregnant women who'd be willing to have themselves used as guinea pigs.

In hopes of finding out more about how drugs react with the bodies of pregnant women and the fetuses they are carrying, researchers at the Food and Drug Administration are calling for more research on pregnant women in an article published this week in the New England Journal of Medicine.

The call was prompted by the H1N1 epidemic last year. Swine flu hit pregnant women much harder than other populations, leading to miscarriages and even deaths.

However, little is known about the correct dose of medicines for pregnant women, so it's possible women who got sick were exposing their babies to the drugs needlessly, and the women were becoming very ill if the dose they were given wasn't enough to help them. The article isn’t calling for pregnant women to use experimental drugs, like, say, a cancer patient might if other medicines aren't working. Instead, it calls for doctors to encourage them to participate in studies under certain conditions, including:

  • When they are already taking a drug and agree to allow their outcomes to be tracked in an “exposure registry";
  • In clinical trials that have already been through several levels of success;
  • When there’s no other drug that would be suitable for a serious or life-threatening condition.

If you're pregnant and you get sick, is a good resource to see what drugs the FDA classifies as safe, probably safe, inadvisable, or dangerous. You can search by generic or brand name. 

Would you have allowed yourself to be studied in the manner the FDA is proposing? How did you decide what, if any, medicines to take while pregnant?

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