The reality is that some women get sick and are diagnosed with serious diseases during pregnancy. Or they may have a chronic illness that needs to be managed while pregnant. Sometimes making the decision whether to take medication during pregnancy is not so easy.
It is difficult to study new medications in pregnant women, and even more difficult to assess the effects of medication on the developing fetus. Pregnant women are considered a vulnerable group by regulatory agencies and ethics committees, and so there are significant practical, legal and ethical obstacles to designing and conducting clinical trials in pregnant women. Due to the limited number of studies evaluating the safety and efficacy of a medication in pregnant women, pregnant women and their healthcare providers are faced with a difficult decision when deciding whether or not to continue or start medications during pregnancy. In addition, emotional factors, societal pressures, and other outside influences can make the decision-making process even more difficult for the woman.
Chronic Illness and Pregnancy
Once pregnant, women with chronic illnesses often find themselves in a difficult situation. Sometimes, disease specialists transfer the care of a pregnant woman over to the obstetrician, who is responsible for her care while she is pregnant. It is often left to the woman to coordinate her care and the transfer of knowledge between providers.
“The obstetrician may or may not have up-to-date knowledge about the specific disease or current medications and may or may not feel equipped to advise on continued treatment,” says Angela Quinn, clinical research scientist at Pfizer and International Board-Certified Lactation Consultant. “Because there are now two patients to consider, the mother and the fetus, decisions are complicated by management of pregnancy as well as an effective management of a specific chronic illness.”
Considerations in Pregnancy
Many pregnant women are faced with having to decide whether or not to take certain medications to manage an acute or chronic illness or serious disease.
If you are facing such a decision, the first things to consider are:
- Your overall health.
- The seriousness of the condition.
- The potential risk to the fetus.
- A realistic assessment of the benefits of taking the medicine versus the overall risks.
Shared Decision Making
Taking a medication while pregnant is a very individual decision and depends on many factors, including known or theoretical risks of treatment to the developing fetus, whether or not other treatments are available, the severity of the condition or illness, and the risks of not treating the condition.
Providers face the same lack of information as pregnant women, but some may be more adept at helping you make a decision that you feel good about.
It is crucial to find a provider who will take time to help you understand your options. Some questions you may want to ask your provider include:
What are the actual and theoretical risks to the fetus or infant if I decide to take this medication? Are there known safety concerns?
- What are the risks to my own health if I do not take this medication?
- Are there risks to my fetus if I do not treat my condition?
- Is there another option that is generally considered safer in pregnancy that may have the same therapeutic effect?
- Is this a temporary situation or will I be taking this medication for a long period of time?
- Help me understand the properties of this medication and how that impacts my decision?
- How does the stage of my pregnancy impact the potential effects of this medication?
If you think you’re experiencing an adverse event with any medication, you should contact your healthcare provider right away and then report it to FDA MedWatch.
- 1. Centers for Disease Control and Prevention. Medications and Pregnancy. Accessed September 9, 2014.
- 2. IRB Guidebook. Chapter VI Special Classes of Subjects. Accessed September 19, 2014.