SECOND OPINION | Pregnancy paradox: Dangers of not testing drugs on pregnant women – Health

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Pregnant women can get sick. And women with illnesses do get pregnant. Yet most drugs have never been tested for their effects during pregnancy.

That’s because pregnant women are usually excluded from drug trials because the risks are considered too great.

‘It’s in the interest of the fetus that the woman is well. That’s an important mind-shift that we need to make.’
–  Indira van der Zande, University Medical Centre Utrecht

The result? A knowledge gap that’s putting both the woman and the fetus at greater risk, according to a recent paper in the BMJ Journal of Medical Ethics.

It’s estimated that nine out of 10 women will take at least one prescription drug during pregnancy. Yet most of those drugs come with no instructions about how to prescribe them for pregnant women.

“For 97 per cent of the medications there is no evidence and the result of that is physicians must prescribe off-label medications” said Indira van der Zande of the University Medical Centre Utrecht in the Netherlands. “Also, the doctor or the woman herself might discontinue medically important medications during pregnancy.”

Van der Zande examined the assumption that pregnant women are too vulnerable to be included in medical research. She concluded there is no reason to leave pregnant women out of drug trials. They are capable of giving informed consent, and they’re also able to grant consent on behalf of their developing fetus.

“The fears about the effects on the fetus are valid,” van der Zande told CBC Health. “But not including pregnant women in studies is also harmful to the fetus.”

It’s in the interest of the fetus that the woman is well, she said, and “that’s an important mind-shift that we need to make.”

“There is a desperate need to shift the paradigm to protect pregnant women through research, not just from research,” bioethicist Carleigh Krubiner of Johns Hopkins University in Baltimore wrote in an accompanying commentary.

There are growing signs that shift may have started. Last year, international research ethics guidelines were updated to clarify the rules about the use of pregnant research subjects.

And in January, the U.S. government updated its policy for the protection of human subjects by removing pregnant women from the list of populations that are…

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