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Is medication data on pregnant patients inadequate?

Even with the assistance of modern technology, a doctor must remain vigilant in monitoring a woman during the course of her pregnancy. Part of the reason is, surprisingly, a lack of data on medication interactions.

Specifically, although substantial data may exist on a medication’s efficacy and potentially harmful side effects in non-pregnant patients, current regulations greatly limit the participation of pregnant women in medical research. Consequently, there simply may not be enough data for a pregnant woman to make an informed decision about whether she should take certain medications while pregnant, or whether certain drugs might increase the risk of a birth defect or birth injury

Another obstacle to informed consent may be medication labeling. Presently, the U.S. Food and Drug Administration maintains a pregnancy exposure registry about birth defects and infant health, including potentially adverse medication reactions during pregnancy. However, although the FDA has proposed a pregnancy and lactation labeling rule that would require medications to include fetal risk precautions in their labeling, the rule has yet to be finalized. 

It’s unclear why change in this area hasn’t come sooner. There’s certainly a sizable population for research: Around 62 million American women are currently of childbearing age, and approximately four million American women give birth each year. Yet pharmaceutical companies may not have an adequate financial incentive to conduct lab research and/or clinical trials focusing on medications that are safe for pregnant women.

An attorney that focuses on medical malpractice might caution against relying on assumptions unsupported by scientific research. The reason is simple: Without informed consent, a pregnant patient might unknowingly increase the risk of injury to herself or birth defects. What this means for pregnant woman concerned about their health is a reminder to ask lots of questions from their health care providers -- even if existing data does not provide much guidance. 

Source: Huffington Post, “Pregnant Women Must Be Studied Too,” Martha Nolan, Vencenzo Berghella and Katherine L. Wisner, Oct. 21, 2014

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