Weighing The Risks Versus The Benefits

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​As featured in 1000 Watts Magazine – a bright idea for patients by patients – 1000wattsmagazine.com – Photography by Mark Fratoni

 

A Discussion of the Challenges Pregnant Women Face When Deciding to Use Medications While They’re Caring for Two

Precluding pregnant women from clinical drug research presents risks 

According to the Centers for Disease Control and Prevention, 9 out of 10 women take medicine during pregnancy, 7 out of 10 report take at least one pharmaceutical medication. For many pregnant women, choosing to take medications during pregnancy is a difficult decision. The risks associated with taking most medications during pregnancy is largely unknown, mainly due to the long-held standard that it is unethical to include pregnant and breastfeeding women in clinical trials and other research studies to determine drug safety and efficacy. The health risks to the developing fetus are too great, and therefore, this population gets left out of necessary research. Pregnant women are still women with health conditions and illnesses that require treatment, so very often, women are left having to weigh the risk versus benefits for taking medications during pregnancy. The same risk versus benefit analysis is also necessary in the breastfeeding period. In this regard, women typically find themselves having to consider the potentially negative impacts for their babies should they choose to use a medication, or the potentially negative impacts that they could face should they choose not to take the medication in question. In both cases, the decision is profoundly difficult.

How do pregnant women decide whether or not to use a medication, with or without the oversight of their obstetrician or midwife?

The U.S. Food and Drug Administration (FDA) has a convenient list of categories that many women turn to when they are trying to determine if a medication is safe to consume during the perinatal period or not. These risk categories were developed because an estimated 10 percent or more of birth defects result from maternal drug exposure, therefore health practitioners and women needed a simple way to review risks for the purpose of making informed decisions. (These categories have been revamped in recent years to include lactation risks, but for the purpose of this article, we’ll stick with the original category list.)

Unfortunately, due to the fact that women who are pregnant and breastfeeding are largely precluded from drug clinical trials and research studies, some of the FDA risk categories carry a common and less than reassuring theme. Category A drugs tend to be considered relatively safe throughout all trimesters, for example — levothyroxine (Synthroid) can be found in this category. Categories B and C were developed on results from animal reproduction studies which may or may not transfer well to clinical use in human beings. Both categories carry the statement “there are no adequate and well-controlled studies in pregnant women.” Category B lists many over the counter medications including Tylenol and Benadryl, considered very safe by most perinatal and obstetric health providers. And then there are Categories D and X where there is “positive evidence of human fetal risk” determined mainly by adverse reaction reports.

The challenge of treating mental illness during pregnancy

Category C is arguably the most disconcerting because this is the category where most commonly prescribed antidepressants fall. Herein lies a significant issue — women in the childbearing years are at increased risk for developing depressive and anxiety disorders. As a result, antidepressants, specifically selective serotonin reuptake inhibitors (SSRIs) are the most frequently used class of prescribed drug by pregnant and breastfeeding women. But the use of these medications is not without risk, especially during the first trimester in which there is an increased risk of miscarriage with the use of some SSRIs. All psychotropic medications cross the placenta and risks to the developing child do exist. These medications may alter brain development in the exposed fetus which may lead to increased rates of depression later in life.

Category D is where anti-anxiety medications tend to fall. Klonopin, ativan, and xanax and other benzodiazepenes comprise this category. These drugs are not prescribed to to pregnant women as regularly as SSRIs, but the use of these medications is prevalent enough to note. These drugs also cross the placenta. Newborns exposed to benzodiazepenes inutero may struggle with decreased muscle tone, breathing challenges, and increased sedation which may be disruptive to mother-baby bonding and the initiation of breastfeeding.

For a pregnant women who are experiencing psychiatric illnesses, there are few easy answers in regards to treating their illness while pregnant. Women who choose to avoid medication run the risk of developing perinatal mood disorders during the prenatal and postpartum periods which may also have devastating consequences for both mother and child. For many women, the risk of potentially harming their child makes the difficult choice for them. They simply decide to place their own health at risk for the benefit of the child. And in turn, many of these women seek alternatives.

What is known about CBD/cannabinoid use during pregnancy?

At the time of this writing, there have been no serious adverse events reported from the use of CBD during pregnancy. However, with every drug, whether it’s a prescribed pharmaceutical or a plant-based medicine, there is always risk associated with use during pregnancy. In the case of cannabinoids, there are a great deal of unknowns. The very small collection of cannabinoid research studies centering on pregnancy tend to focus on tetrahydrocannabinol (THC), the cannabinoid known for causing the high associated with cannabis. Low birth weight, pregnancy complications, increased risk of Neonatal Intensive Care Unit (NICU) admission have been correlated with prenatal exposure to THC. It’s important to note these risks are associated with smoking cannabis, and these findings may be limited due to confounding factors such as concurrent use of other substances like alcohol and tobacco. For CBD, the studies are severely limited. One study suggested the CBD may make the placenta more permeable, which may place a fetus at risk of exposure to harmful compounds. Another study suggested CBD may reduce uterine contractions, which means it may be a promising treatment for pre-term labor in the future.

It’s also important to note that cannabis has been used by women in the perinatal period for millennia. In modern times, there have been a few longitudinal studies that followed people exposed to cannabis prenatally, each came up with a similar findings — there were no developmental differences between people who were exposed to cannabis during pregnancy and people who were not.

 

This is not to say that cannabis is without harm — we do know that cannabis use through adolescence can have negative effects on the developing brain resulting in a range of problems from decision-making faculties that are greatly impeded, to depression, to other issues related to cognitive ability and mood stabilization.

What about Cannabidiol (CBD) for prenatal psychiatric illness?

CBD is psychoactive when ingested, but tends not to be impairing or intoxicating. (Anything that effects the mind is psychoactive. Caffeine and sugar are psychoactive for example.) There are CBD-rich strains that can certainly be consumed via smoking, but in most cases, it is taken via other methods of use such as tincture taken sublingually, and salves applied topically. For pregnant women experiencing pain and discomfort, a topical may be ideal. For women struggling with mental illlness or a psychiatric health issue who would rather not take a pharmaceutical, CBD may be a good alternative.

In animal studies, CBD has demonstrated properties similar to antidepressants and anti-anxiety medications like benzodiazepenes. Which means CBD may be a great alternative for pharmaceutical medications that carry more significant and well-understood risks. These studies are promising, but unfortunately have not crossed over into human studies. Certainly not for the pregnant population. The volume of anecdotal evidence in this regard is ever-growing however, and this patient driven cannabis movement has really forced the attention of the medical community. So we can expect this body of research to expand, albeit slowly under current restraints caused by federal prohibition.

Making informed decisions for the best outcomes

For CBD or cannabis use in general, microdosing is key — finding the least amount of medication for the desired effect is the goal for everyone — pregnant and non-pregnant people. There is no shortage of CBD products on the market, some of high quality, some are really junk. To this end, CBD products should be sourced from reliable companies with good manufacturing processes. Companies should be contacted prior to purchase and lab testing results should be requested and acquired. Test results should indicate the amounts of active cannabinoids that can be found in the package, and that the product is free of contaminants such as heavy metals and bacteria.

It is imperative that pregnant women weigh the risks versus the benefits associated with using any drug, medicine, and substance during pregnancy. Pregnant women need to assess why they are using any substances and endeavor to maintain that assessment throughout the pregnancy. Pregnancy can be a roller coaster of emotions and women should really see how they’re feeling on a day-to-day basis to determine what intervention is needed to relieve symptoms, if any intervention is needed at all.

Every pregnant woman who is interested in using cannabis during pregnancy should work with qualified health practitioners who are knowledgeable about cannabis use during the perinatal period, or practitioners who are at least open to providing guidance and support so that an informed decision can be reached. Pregnant women need to feel comfortable with their prenatal healthcare providers and the decisions they make in collaboration with those healthcare providers. This level of comfort plays a great role in outcomes for both mom and baby. In the end, the goal is healthy happy families.

References

Armstrong, C. (2008, September 15). ACOG Guidelines on Psychiatric Medication Use During Pregnancy and Lactation. Retrieved from https://www.aafp.org/afp/2008/0915/p772.html

Depression. (2018, October 18). Retrieved from https://www.womenshealth.gov/mental-health/mental-health-conditions/depression

Depression During Pregnancy: Signs, Symptoms & Treatment. (2017, July 20). Retrieved from http://americanpregnancy.org/pregnancy-health/depression-during-pregnancy/

Depression in Women: 5 Things You Should Know. (n.d.). Retrieved from https://www.nimh.nih.gov/health/publications/depression-in-women/index.shtml

Echo. (2017, November 30). Is It Safe to Take CBD Oil While Pregnant? Retrieved from https://echoconnection.org/safe-take-cbd-oil-pregnant/

FDA Pregnancy Categories – CHEMM. (n.d.). Retrieved from https://chemm.nlm.nih.gov/pregnancycategories.htm

Houlihan, D. D., Dennedy, M. C., & Morrison, J. J. (2018, October 21). Effects of abnormal cannabidiol on oxytocin-induced myometrial contractility. Retrieved from https://rep.bioscientifica.com/view/journals/rep/139/4/783.xml

Kerr, S., MD. (n.d.). Cannabis Use During Pregnancy: Is it Safe? Retrieved from https://www.projectcbd.org/about/clinical-research/cannabis-use-during-pregnancy-safety

Treating for Two: Medicine and Pregnancy. (2018, April 30). Retrieved from https://www.cdc.gov/pregnancy/meds/treatingfortwo/infographic.html

Women’s Health Care Physicians. (n.d.). Retrieved from https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Marijuana-Use-During-Pregnancy-and-Lactation

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