Science is constantly revealing what we thought we knew (or were told) as incomplete. Many studies are retrospective, requiring a series of events to occur before the impact of the intervention is known. Here are a few recent examples that emphasize why medication / vaccine safety isn't as straightforward as early research or public-health guidelines often imply.
Opioid Use by Women: Bad for the Mother, Bad for the Child
Just over 20 years ago, opioids were thought to be a relatively safe, non-addictive way to relieve pain. Ten years later, approximately one in three reproductive-aged women were filling opioid prescriptions each year.1 By 2014, the number of women with opioid use disorder at time of delivery had more than quadrupled.2
We now know "for mothers, opioid use disorder has been linked to maternal death; for babies, opioid use disorder or long-term opioid use has been linked to poor fetal growth, preterm birth, stillbirth, specific birth defects, and neonatal abstinence syndrome."3 The public learned about neonatal abstinence syndrome (NAS) when it became the focus of mainstream media in the early 2010s, with a number of television segments showing shocking footage of newborns withdrawing from their mothers' opioid addictions.4-6
Adding to what is already known, authors of a new study determined that "higher risks were found for overall minor birth defects in trimester 3 (aRR, 1.26; 95% CI, 1.04-1.53) and minor birth defects in the musculoskeletal system in trimester 2 (aRR, 1.50; 95% CI, 1.10-2.03) and trimester 3 (aRR, 1.65; 95%CI, 1.23-2.22)." These included "plagiocephaly, polydactyly, and other specified congenital deformities of the hip."7
Ironically, a mother suffering from low back pain, headache and chronic pelvic pain (the most frequent complaints) was prescribed an opioid that inflicted musculoskeletal damage on their unborn child. As the authors noted, "[C]omprehensive educational initiatives are necessary to remind obstetricians, nurse midwives, and any other clinician who cares for women in pregnancy, including in an emergency setting, that nonopioid modalities for pain management should be first line therapy during pregnancy."7
Restricting Alcohol During Pregnancy: Not Just a Mom Rule
Most people are aware that maternal alcohol consumption during pregnancy can cause birth defects (also known as fetal alcohol spectrum disorder or FASD), as this fact is regularly presented in literature and the media. Even though this relationship was suggested in writings as early as the 18th century, some of the first studies were not conducted until the 1960s.8
Now, a recent study reveals that "the risk of birth defects was higher among couples with paternal alcohol consumption (odds ratio [OR], 1.35; 95% CI, 1.14-1.59; P < .001)." This is true in preconception, as "paternal alcohol consumption may increase the risks of birth defects in offspring by affecting sperm cells." The authors advise that "future fathers should be encouraged to modify their alcohol intake before conceiving to reduce fetal risk, considering a paternal drinking rate of 31.2% substantially elevated the risk of birth defects."9
So, more than 50 years later, we see that preconception paternal alcohol consumption can be a factor in causing birth defects. It will probably take several more studies and years before most providers become aware of these findings; and another decade or more before the public understands the relationship.
COVID Vaccination Effects: What Don't We Know (Yet)?
At the same time as the above recent studies were published, another study was examining the impact of the two-dose COVID vaccine on breast milk. These authors found that "(m)ean levels of anti–SARS-CoV-2-specific IgA antibodies in the breast milk increased rapidly and were significantly elevated at 2 weeks after the first vaccine (2.05 ratio; P < .001), when 61.8% of samples tested positive, increasing to 86.1% at week 4 (1 week after the second vaccine). Mean levels remained elevated for the duration of follow-up, and at week six, 65.7% of samples tested positive."10
In addition, of the 84 women in the study, "forty-seven women (55.9%) reported a vaccine-related adverse event after the first vaccine dose and 52 (61.9%) after the second vaccine dose, with local pain being the most common complaint. Four infants (almost 5%) developed fever during the study period 7, 12, 15, and 20 days after maternal vaccination." (Parenthetical remarks added)
While some media are currently painting a different picture, the CDC webpage on the COVID vaccine for women who are pregnant or breastfeeding begins with the statement that "getting vaccinated is a personal choice."11 However, at the time of this writing, there are very few papers on the impact maternal COVID vaccines could have on newborns and their mothers to provide relevant information to help make that choice. Perhaps the best is "Coronavirus Disease 2019 (COVID-19) Vaccines and Pregnancy: What Obstetricians Need to Know" (published last month), which sums up the current situation:
"Guidance regarding whether pregnant persons should receive a COVID-19 vaccine is needed. Because pregnant persons were excluded from the initial phase 3 clinical trials of COVID-19 vaccines, limited data are available on their efficacy and safety during pregnancy. After developmental and reproductive toxicology studies are completed, some companies are expected to conduct clinical trials in pregnant persons."12 [Emphasis added]
Given the historical progression of research conducted on the impact of opioids and alcohol on the developing fetus through to adulthood, it will obviously require decades of study to begin to understand the impact of the COVID-19 vaccine on mothers and their children.
You may want to share this article with your patients. If nothing else, it should prompt them to ask questions before receiving any medication prescription or vaccine – particularly in cases in which proven, natural options are available.
References
- Opioid prescription claims among women of reproductive age – United States, 2008-2012. CDC Weekly, Jan 23, 2015;64(02);37-41.
- Opioid use disorder documented at delivery hospitalization – United States, 1999-2014. CDC Weekly, Aug 10, 2018;67(31);845-849.
- "About Opioid Use During Pregnancy." Centers for Disease Control and Prevention.
- "Drug-Dependent Infants Detox at Tenn. NICU." ABC News, Jul 11, 2012. www.youtube.com/watch?v=2eP5EnFSG0c&t=183s
- "When Babies Are Born Withdrawing From Opioids." PBS News Hour, Mar 12, 2016. www.youtube.com/watch?v=kYD73NGxpdw&t=114s
- "Born on Opioids: What It's Like." Today's Parent, Sep 26, 2017. www.youtube.com/watch?v=pmt3Fsw37gI&t=341s
- Wen X, et al. Association of gestational opioid exposure and risk of major and minor congenital malformations. JAMA Netw Open, Apr 13, 2021.
- Lemoine P, et al. [Children of alcoholic parents: abnormalities observed in 127 cases]. Ouest Med, 1968;25:476-482.
- Zhou Q, et al. Association of preconception paternal alcohol consumption with increased fetal birth defect risk. JAMA Pediatr; online first Apr 19, 2021.
- Perl SH, et al. SARS-CoV-2–specific antibodies in breast milk after COVID-19 vaccination of breastfeeding women. J Am Med Assoc; online first Apr 12, 2021.
- "Information About COVID-19 Vaccines for People Who Are Pregnant or Breastfeeding." Centers for Disease Control and Prevention.
- Rasmussen SA, et al. Coronavirus Disease 2019 (COVID-19) vaccines and pregnancy: what obstetricians need to know. Obstet Gynecol, 2021 Mar 1;137(3):408-414.
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