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Why So Little is Known About Drug Safety in Pregnancy

One of the most common questions I hear and see asked in our forums is about the safety of medications during pregnancy. If I had a dollar for every time I heard someone ask if a certain medicine is safe, I’d be too busy lying on my private island to be writing this blog. I had the same concerns with each of my babies.

The doctor often gives you a limited list of drugs that are considered to be safe. This is a relatively short list and includes mostly medicines that have been around for a long time. The reason they are considered safe is that women have been taking them for years and no negative side effects have been noted with their use.

Drugs are classified according to safety. Some are considered completely unsafe. Again, this is because there have been documented side effects that are serious enough to outweigh the potential benefits of the medication. Overall, the drugs considered totally safe and the ones considered completely unsafe are a small portion of the drugs on the market. Most are labeled Class C, which means they think they’re ok, but no one knows for sure.

Why don’t we know? Because pregnant women are generally excluded from clinical research on drugs. Researchers are reticent to include pregnant women for ethical reasons. If the drug is found to be unsafe, researchers don’t want to be responsible for damage to mothers or babies.

The question of why women aren’t included was raised recently at Duke University Medical Center and Georgetown University. Researchers here and at Johns Hopkins are saying that challenges can be addressed and pregnant women included in future research studies. Of course, criteria would have to be set to ensure a reasonable amount of safety.

The reason researchers want pregnant women included is not just for information about risk, but to determine the benefits of some medications for pregnant women. This may result in more drugs being deemed safe and therefore available to treat a wide range of conditions during pregnancy.

In addition to reaping benefits from the medication, there would be better information about the correct dosage of medicines for pregnant women. There are differences in metabolism when a woman is pregnant, compared to when she is not. These differences can affect the effectiveness of the drugs. If they were included in the studies, doctors would know the best dosage to prescribe.

Whether drug companies respond favorably to the suggestions of the researchers’ remains to be seen. Pharmaceutical companies may hesitate to include pregnant women due to the perceived risk of complications or negative side effects on the fetus.

Related Articles:

Concerns about Epilepsy Drugs

Understanding Drug Categories for Pregnant Women

The Effects of Illegal Drugs on the Fetus

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About Pattie Hughes

Pattie Hughes is a freelance writer and mother of four young children. She and her husband have been married since 1992. Pattie holds a degree in Elementary Education from Florida Atlantic University. Just before her third child was born, the family relocated to Pennsylvania to be near family. She stopped teaching and began writing. This gives her the opportunity to work from home and be with her children. She enjoys spending time with her family, doing crafts, playing outside at the park or just hanging out together.