Imagine being pregnant while having a chronic health condition such as diabetes, hypertension, depression or asthma, or being diagnosed with an illness while pregnant. Amazingly, your doctor may not know exactly what treatments or drugs, or what dose, will work best for you. This is a reality faced by millions of American women every day.
The simple fact is, pregnant women get sick and sick women get pregnant. Meanwhile, rates of chronic disease are rising and women are having children at an older age. Stopping medication or avoiding new treatments is not always the optimal approach. Significant knowledge gaps exist because pregnant women have historically been excluded from medical research, mainly due to concerns about the effect on the fetus. But even a normal pregnancy has risks.
There is a common belief that medication during pregnancy is unhealthy and unwise. Past tragedies – such as the limb-reduction birth defects related to first trimester thalidomide exposure – serve to support careful consideration of the risks and benefits of drug treatment. But avoiding all medication use is not a realistic possibility.
Failing to take medication, taking inappropriate doses or not being prescribed a needed treatment can be harmful or fatal for a mother or her unborn child. Today, an American woman will take at least one and on average four medications during her pregnancy. Health care professionals, though, often have inadequate information about how a drug works during pregnancy because most medications have not been evaluated in pregnant women.
Confronted with this lack of data, a woman who is pregnant or nursing may stop taking drugs or breastfeeding, even though that may not be the best course of action. With more information about both the benefits and risks of drug expsoure, she might choose to continue medications that improve her short-term and long-term health and quality of life while minimizing harm to herself or her baby.
Moreover, newer medications shown to be effective in non-pregnant patients have the potential to improve disease outcomes in pregnancy, but have not yet been tested in pregnant women. For example, newer treatments for hepatitis C may help prevent the mother-to-child transmission of hepatitis C, but they need to be studied in pregnancy.
Unfortunately, this lack of new scientific information leads to uncertainty for health care professionals about how to prescribe needed medications and sometimes results in no treatment at all for pregnant or breastfeeding patients with an illness. Worse, in the search for answers, many pregnant women turn to the internet and social media, which often results in conflicting, confusing and just plain wrong advice.
Rx: collect more data
Our nation must do better. Currently women – pregnant or not – are vastly underrepresented in clinical trials. Pregnant women should determine what level of risk they are willing to take. A robust, transparent informed consent process can help them make this decision. Though pregnant women have participated in some studies, most research protocols continue to exclude pregnant or breastfeeding women, and this just has to change.
Additionally, we need to improve data collection related to drugs and pregnancy, which is currently inadequate to make informed decisions. For example, the US Food and Drug Administration keeps a list of what are called Pregnancy Exposure Registries that collect health information, mostly on birth defects and infant health, from researchers and drug companies about women who take medicines or vaccines while pregnant.
Existing data from these registries should be standardized and easily accessible to support sound decision-making by providers and patients. Pregnancy registries should be required for new drugs, and registries must capture not just adverse events but healthy outcomes to create a baseline of both positive and negative medical data.
Also the US Office of Management and Budget should finalize the long-pending FDA Pregnancy and Lactation Labeling Rule, which would provide patients and prescribers detailed, updated information about fetal risk, clinical considerations and the quality of studies available for each drug.
Federal policymakers and the medical community must re-evaluate the near-exclusion of pregnant women from medical research and strengthen requirements to collect as much data as possible, including follow-up with women who become pregnant and drop out of a study.
Incentives, such as longer exclusivity clauses or fast track designation for an unmet need, must be created for pharmaceutical companies to perform lab research and clinical trials focusing on pregnancy when seeking approval for new drugs that may be used by pregnant women.
By taking these actions, pregnant women will be better served by medical research. With 62 million women in the United States of childbearing age and 4 million births each year, getting the best possible health care is vitally important now and for generations to come.
This piece was co-authored by Martha Nolan, JD, Vice President of Public Policy at the Society for Women’s Health Research.
Katherine Wisner has received funding from NIMH, NICHD, and the Department of Psychiatry at Northwestern receives Consultation Fees from Dr. Wisner’s work with Quinn-Emanuel Law firm, which represents pharmaceutical companies.
Vincenzo Berghella does not work for, consult to, own shares in or receive funding from any company or organisation that would benefit from this article, and has no relevant affiliations.