Over-the-Counter Medicines and Pregnancy

Deciphering Drug Safety Categories
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What's a mommy-to-be to do when she's suffering with an illness? Understanding the categories of drug safety for pregnancy can help you decide what's best for you and your unborn child.

It's a miserable experience being pregnant with a cold. It's bad enough to be waddling around like a giant penguin, but when your center of gravity is already off, and you're dizzy from a sinus infection, a simple sneeze may send you sprawling, and every cough can send shooting pains through your already-stretched-to-the-max abdominal ligaments.

Pre-pregnancy, a trip to the local pharmacy was all you needed for symptomatic relief from most aches, sniffles, and coughs; but now that you're a pregnant woman, you'll read label after label admonishing you to steer clear of the very products you need to stop your drippy nose, clear up that chest congestion, or relieve your fever.

So what's a responsible mommy-to-be to do when she's suffering through the cold season or trading illnesses with her toddler for weeks? Are herbal remedies safe and effective during pregnancy? Should she take smaller doses of the usual over-the-counter medications, or is staunch stoicism the only safe option for the expectant woman?

Understanding What's Safe

When I was pregnant with my son I managed to make it through the entire nine plus months with nary a sniffle. Yet with my second pregnancy, no sooner had I passed the first trimester nausea than I was—thanks to my four year-old Petrie dish—slammed with back-to-back illnesses, including bronchitis, ear, nose, and throat infections, and several bouts with the common cold.

Although I was confident my doctors knew what was best for me and my little passenger, I felt guilty each time I reached for a teaspoon or capsule of relief. After all, many of the labels were clearly marked with ominous warnings about taking the medications during pregnancy.

Still, my doctor assured me, it was better to take my asthma meds than to deprive the baby of oxygen. It was better to take the cough medicine than to cough my way into a rare but possible placental abruption, and it was better to take a fever-reducer than to risk raising the baby's body temperature more than a degree or two above normal. During pregnancy, any medication carries a potential risk, he told me, but when the risk to my unborn baby outweighed the risk of taking the medication, it was a risk, and a medication, worth taking.

"Safety is a relative issue when it comes to taking drugs during pregnancy, and some drugs are safer during pregnancy than others," says Dr. Kathleen Uhl, team leader for the pregnancy and lactation team at the Food and Drug Administration (FDA). "You start to get information on drug use in pregnancy after a drug's been marketed, so the longer a drug's been out there, the more likely it is that there's some information on the outcomes of pregnancies that have been exposed to this product. With newer products, there's very little knowledge."

Dr. Uhl says that, because no pregnant women are allowed to participate in clinical drug development trials, there is very little data on the effects of certain drugs during human pregnancy until later epidemiological studies are conducted.

"But there are specific reproductive toxicology studies in animals that are required by the FDA, and these specifically look at the effects of drugs on the pregnant female and her fetus," she says. "Typically, those studies also follow them into the lactation period."

Because the majority of animal drug studies are conducted on mice, rats, and rabbits, Dr. Uhl says the issue of whether or not there is an adequate correlation between the effects of studied drugs on animal fetuses and on human fetuses is extremely controversial among pharmacology and toxicology specialists.





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