Pregnant Women Will Finally Be Included In Clinical Drug Trials

Pregnant Women Will Finally Be Included In Clinical Drug Trials

The FDA recently released upcoming guidelines for the inclusion of pregnant individuals in clinical drug trials.

For decades, pregnant people have been cautioned against taking medications. Most people assume this is because the medications are not safe for either parent or child. While that may be true for some medications, it isn’t quite the case for many.

The real reason that pregnant people are warned against many medications is that doctors and researchers just don’t know how the drugs will interact because pregnant people have never been included in medical trials. That is about to change.

In April 2018, the Federal Drug Administration (FDA) put out a document covering the best way to begin including pregnant people in clinical drug trials. The document, still just a draft and is “not for implementation” just yet, is called Pregnant Women: Scientific and Ethical 2 Considerations for Inclusion in Clinical Trials Guidance for Industry. The document “addresses considerations such as the effect pregnancy has on the absorption of drugs, nonclinical studies that should be conducted, and appropriate data collection and safety monitoring.”

This is an important step for people already suffering from chronic and mental illnesses when they get pregnant. The labels currently used on drugs regarding pregnant people are “usually based on nonclinical data” and used as more of a precaution because researchers often have no concrete evidence how a developing fetus could be impacted by medications, if at all. For example, roughly 98 percent of the drugs approved by the FDA from 2000 to 2010 found that there wasn’t enough data to “determine the risk of harm to the fetus.”

People with preexisting conditions that require medication for treatment are often caused more harm by stopping medication during pregnancy. Due to the lack of understanding of how certain drugs will impact a fetus, doctors often opt not continue the treatment during pregnancy. There is also stigma against using medication during pregnancy even for chronic conditions, such as depression, epilepsy, and asthma.

It turns out that pregnant people are already using medications, making the data to back up the usage all the more crucial. A study conducted in 2011 discovered that 23,5000 out of the 25,000 pregnant people that took part in the study took at least one drug while pregnant. The average number of drugs taken during pregnancy has increased over the years.

Anne Lyerly, a bioethicist and OB/GYN at the University of North Carolina at Chapel Hill, is one of the  leading researchers in medication and pregnancy. She says that the FDA creating criteria for clinical trials for pregnancy is “an important beginning to the conversation.”

Much of the modern day concern for pregnant people participating in drug trials is a result of thalidomide in the 1950s and 60s. Thalidomide, a sedative, was prescribed to relieve nausea during pregnancy and ended up causing “severe congenital malformations” to thousands of children, many whom survived only a few days before dying. This played into the decision to exclude pregnant people from clinical drug trials.

Lyerly says that the problem with the thalidomide tragedy is that the drug wasn’t studied on pregnant people at all. If it had been, things likely would have turned out much differently. “If you don’t study a drug in a highly controlled research setting, it’s not like the risk that would be imposed on those individuals goes away.” The risk only then gets “shifted” to people that need to take a medication or are already taking it when they get pregnant. “If you are not going to conduct these research studies, it’s not like you’re off the hook, morally speaking, at all. It means the risk is going to be put somewhere else.”

It will likely be some time before any information is released on the effects of pregnancy and certain medications. In the meantime, the American Pregnancy Association has some guidelines that can help you and your doctor make the best decision for you and your pregnancy.

  • Consult your doctor before making any decisions.
  • Read labels before taking any medications.
  • Find out side effects before taking a drug. Some side effects, such as headaches and vomiting, can be “enhanced because of pregnancy hormones.”
  • Keep all your vitamin and medications organized so you don’t mix them up and potentially overdose.
  • Don’t skip any doses.
  • Don’t share your medications with anyone.
  • Ask your doctor about medication benefits and risks, problems you should watch out for, and side effects.
  • Keep a record of medications you are taking and side effects you experience.

Including pregnant people in clinical drug trials is a concern over both “fetal safety” and “maternal benefit,” and strives to provide safer options for people in the future. Lyerly says, “Drug treatment is not the enemy. It’s a tool in a tool chest that is important to ensuring healthy moms and healthy babies.”

Cover image courtesy of Getty Images.