Tackling Drug Safety in Maternal and Newborn Populations
Hello again, Gentle Reader, and here's hoping you are having a healthy, happy, hopeful April. The saying "He who has health, has hope; and he who has hope, has everything" has been attributed to a wide range of sources from Arabian proverbs to Thomas Carlyle, and as we get older and feel the effects of age, it seems to be truer than ever. It's frustrating to find that the cavalier way we may have treated our bodies (and indeed, our minds as well) in our youth can have disconcerting consequences after a half century or so, and become harder and harder to reverse. Hence, the need for a World Health Day to remind us to take stock of the difference between where we are and where we aspire to be, and reset either our expectations or our efforts.
One facet of effective communication in healthcare is being able to express clearly both the problem(s) and the potential solutions; not only from an individual perspective but also from a population or societal perspective; particularly when certain of these are disadvantaged. In our lead article below, our HOC Editor Beth Howe pulls out some of these issues and how, globally, we might work to improve the health outcomes. Not least of which is the communication aspect.
Happy reading,
Ruth
World Health Day: April 7 2025
The theme for World Health Day 2025, "Healthy beginnings, hopeful futures," focuses on maternal and newborn health. This theme underscores the essential role that healthy pregnancies, safe births, and strong postnatal care play in ensuring healthier communities and families, with lasting impacts on societies as a whole.
Despite significant progress in healthcare, approximately 300,000 women still die each year from pregnancy or childbirth complications—many of which are preventable. This stark statistic underscores the ongoing challenges in safeguarding maternal and newborn health worldwide.
A Critical Issue: Drug Safety in Pregnancy and in Newborns
One of the most pressing issues that must be addressed is the safety of treatments for pregnant women and their babies, particularly in relation to drug approvals.
The Challenge in Drug Approval
The approval process for medications for these populations is fraught with difficulties, especially in the context of clinical trials. Pregnant women and children have often been excluded from these studies, resulting in a significant gap in data about the safety of drugs for these groups.
The Consequence: Limited Treatment Options
As a result, medications approved for adults may have contraindications for use during pregnancy or breastfeeding, leaving healthcare professionals and patients with limited treatment options or unclear safety data.
Impact on Chronic Disease Management
Patients with chronic conditions like arthritis often experience improvements during pregnancy. However, ongoing treatment options need careful evaluation.
- Safe medications for non-pregnant adults may have a different safety profile during pregnancy.
- Healthcare providers must navigate complex decisions regarding the continuation, alteration, or discontinuation of medications during pregnancy.
Drug Approval and Family Planning
Treatment planning for individuals with chronic conditions isn’t just important for health—it’s a critical aspect of family planning.
As the WHO urges governments and the health community to intensify efforts to reduce preventable maternal and newborn deaths, it is equally important to prioritise drug approval processes that ensure the long-term health and well-being of both mothers and babies.
The WHO is clear: it’s up to all of us to make pregnancy and babyhood safer.
Find out how we help researchers and pharma companies communicate complex health data more easily.
The Role of MedComms Agencies and Pharmaceutical Companies in Maternal and Child Health
MedComms agencies play a vital role in translating complex medical research into accessible content, ensuring that critical information about drug safety and health education for pregnant women and children reaches healthcare professionals and the public. A great example of this impact is the Back to Sleep campaign, which helped reduce cot deaths by educating parents about safe sleeping practices. The campaign raised awareness of the importance of placing babies on their backs to sleep, significantly reducing the risk of sudden infant death syndrome (SIDS).
Publishing Sub-Analyses of Clinical Trials
Publishing sub-analyses of clinical trials focused on maternal and child health is essential. These analyses provide critical data on the safety of drugs for pregnant women and children, helping extend drug approvals to these often underrepresented groups and improving healthcare decisions.
Health Education Campaigns
MedComms also develops educational materials to raise awareness about managing preexisting conditions during pregnancy. By informing both healthcare providers and the public, these campaigns empower women to make informed decisions about their health and treatment options.
Advocacy Support
MedComms agencies support policy advocacy by creating persuasive messages that influence drug approval processes and ensure that medications are safe for expectant mothers and children. Their communication expertise helps drive positive change in healthcare and regulatory practices.
Take care of your body. It's the only place you have to live - Jim Rohn
Notable News
- The FDA has approved the first generics of Xarelto (rivaroxaban) for patients with coronary artery disease and peripheral artery disease. These generics offer a more affordable treatment option for reducing the risk of cardiovascular events and stroke. As part of the FDA’s Drug Competition Action Plan, this approval increases access to essential anticoagulants. Link
- A retrospective cohort study from the NIH’s RECOVER initiative has found that SARS-CoV-2 infection in children and adolescents is associated with an increased risk of long-term kidney complications. The study, which followed over 1.9 million pediatric patients, revealed that COVID-19 was linked to a higher risk of new-onset chronic kidney disease (CKD) and composite kidney events in children with preexisting CKD or acute kidney injury. These findings highlight the need for continued monitoring of kidney function in pediatric patients recovering from COVID-19, particularly those with a history of kidney issues. Link
- A new study suggests that weight training could help protect older adults from dementia, a condition that affects millions globally. Previous research has shown that regular exercise can reduce the risk of dementia, but this study highlights the specific benefits of weight training. The study found that weight training may also be beneficial for individuals already showing signs of mild cognitive impairment, suggesting it could be an effective strategy in preserving brain health as we age. Link
- A recent cohort study published in JAMA Psychiatry reveals that machine learning models trained on clinical data could significantly speed up the diagnosis of serious mental illnesses like schizophrenia and bipolar disorder. Researchers led by Dr. Søren Dinesen Østergaard of Aarhus University found that machine learning applied to electronic health record data could help identify high-risk individuals faster, allowing for earlier treatment and better outcomes. Link