“Is It Safe?” — The Many Unanswered Questions about Medications and Breast-Feeding

Byrne, John J.; Spong, Catherine Y.

doi:10.1056/nejmp1817420

Cited by 42 publications

(38 citation statements)

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“…Many pregnancy‐induced or pre‐existing conditions require continued treatment following delivery, raising issues about the transfer of medicines into breast milk and potential risks of infant exposure. A recent study examining 575 new drug approvals by the FDA found that only 15% included data on human lactation . Given the widespread use of medicines in pregnancy and lactation, focus should be switched from questioning the ethics of exposing a fetus or infant to a medicine to the ethics of the routine use of medicines in obstetrics in the absence of clear evidence.…”

Section: Challenges To Develop and Use Medicines In Vulnerable Patienmentioning

confidence: 99%

“…A recent study examining 575 new drug approvals by the FDA found that only 15% included data on human lactation. 39 Given the widespread use of medicines in pregnancy and lactation, focus should be switched from questioning the ethics of exposing a fetus or infant to a medicine to the ethics of the routine use of medicines in obstetrics in the absence of clear evidence. As such, having regulatory agencies encourage sponsors to conduct controlled trials in consenting mothers to address identified evidence gaps is necessary to improve clinical care.…”

Section: Challenges To Develop and Use Medicines In Vulnerable Patienmentioning

confidence: 99%

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Navigating off‐label and unlicensed medicines use in obstetric and paediatric clinical practice

Gray

McGuire

2019

Pharmacy Practice and Res

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Off‐label or unlicensed medicines use is extremely common in obstetric and paediatric clinical practice and necessitates greater emphasis on the underlying evidence of a medicines safety or efficacy. This creates significant challenges for pharmacists relating to the supply and use of medicines in this setting. Understanding how and why unlicensed or off‐label medicine use occurs, together with the underlying evidence base, is critical for supporting the quality use of medicines. Addressing issues surrounding unlicensed or off‐label medicine use in a collaborative manner with prescribers and patients can help reduce unnecessary patient concern, possible non‐adherence and risk of suboptimal treatment outcomes. This review summarises current evidence and challenges surrounding off‐label and unlicensed medicine use in the obstetric and paediatric clinical setting from the perspective of key stakeholders. It aims to support pharmacists in their evaluation of the appropriateness of off‐label and unlicensed medicine use, and provide strategies to help manage these challenging medicines management decisions.

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Section: Challenges To Develop and Use Medicines In Vulnerable Patienmentioning

confidence: 99%

Section: Challenges To Develop and Use Medicines In Vulnerable Patienmentioning

confidence: 99%

Navigating off‐label and unlicensed medicines use in obstetric and paediatric clinical practice

Gray

McGuire

2019

Pharmacy Practice and Res

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“…3 More than 90% of pregnant women will use at least 1 prescription or over-the-counter drug during pregnancy, and about half of breastfeeding women will continue to use prescription medications. 3,4 For these women, a failure to provide appropriate access to information on drug safety is irresponsible and dangerous. Two possible outcomes may arise in the absence of timely information and expert counselling.…”

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confidence: 99%

“…In addition, major knowledge and research gaps remain in drug safety during pregnancy and breastfeeding. 4 Alarmingly, only 10% of drugs approved by the US Food and Drug Administration since 1980 have adequate data to determine an accurate teratogenic risk, and the time for determination of this risk is often decades. 5 Furthermore, most clinical recommendations for drug safety in breastfeeding are not based on lactation-specific data, and less than 2% are based on strong data.…”

mentioning

confidence: 99%

“…5 Furthermore, most clinical recommendations for drug safety in breastfeeding are not based on lactation-specific data, and less than 2% are based on strong data. 4 Research in this area continues to rely heavily on observational data, as pregnant and breastfeeding women have been systematically excluded from clinical trials. 4,6 Motherisk was once a trusted source of knowledge in the field, maintaining extensive databases of drug-safety evidence in response to calls received by its helpline -this valuable information is now unavailable.…”

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confidence: 99%

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Reinvent Motherisk to keep mothers and babies from harm

Zipursky

Russell

Stall

2019

CMAJ

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T his spring, Canada's Motherisk program shut its doors and permanently disconnected its helplines, disappointing the millions of Canadian patients and clinicians who had relied on its services since 1985. 1 At its peak, Motherisk provided evidence-informed counselling on drug safety in pregnancy and breastfeeding to tens of thousands of callers per year and conducted large-scale laboratory and clinical research on maternal-fetal toxicity. The loss of Motherisk has exposed a major public health and research void that is neither quickly nor easily reconciled. Although finding an immediate replacement for Motherisk is not feasible, reinventing a reputable and modernized clinical and research program in reproductive drug safety should be a national priority.The ideal of a "normal pregnancy" free from illness and medications is at odds with reality. Twenty percent of pregnant women have chronic illnesses, and many others will develop pregnancyrelated conditions. 2 Over the past 30 years, the prevalence of prescription drug use in pregnancy has increased by nearly 70%. 3 More than 90% of pregnant women will use at least 1 prescription or over-the-counter drug during pregnancy, and about half of breastfeeding women will continue to use prescription medications. 3,4 For these women, a failure to provide appropriate access to information on drug safety is irresponsible and dangerous. Two possible outcomes may arise in the absence of timely information and expert counselling. First, women may continue drugs that could result in preventable harm to their children. Secondthe more common and likely scenario -is that mothers may unnecessarily stop drugs for fear of harm to the baby. This could leave both mother and baby at risk of harm from untreated medical and psychiatric conditions during conception planning, throughout the duration of pregnancy, and into the postpartum period. None of these outcomes are acceptable.In addition, major knowledge and research gaps remain in drug safety during pregnancy and breastfeeding. 4 Alarmingly, only 10% of drugs approved by the US Food and Drug Administration since 1980 have adequate data to determine an accurate teratogenic risk, and the time for determination of this risk is often decades. 5 Furthermore, most clinical recommendations for drug safety in breastfeeding are not based on lactation-specific data, and less than 2% are based on strong data. 4 Research in this area continues to rely heavily on observational data, as pregnant and breastfeeding women have been systematically excluded from clinical trials. 4,6 Motherisk was once a trusted source of knowledge in the field, maintaining extensive databases of drug-safety evidence in response to calls received by its helpline -this valuable information is now unavailable.The closure of Motherisk followed the program's loss of credibility and external funding amid allegations of research misconduct involving its former director, Dr. Gideon Koren, who also oversaw the disgraced Motherisk Drug Testing Laboratory. 1 Given the fractured ...

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Anemic Data for Preventive Screening and Supplementation to Address Iron Deficiency Anemia in Pregnancy

Duryea,

Spong

2024

JAMA

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The US Preventive Services Task Force (USPSTF) recently released a Recommendation Statement examining the data to support screening for iron deficiency anemia in pregnancy and finding them lacking. 1 It also found insufficient evidence to make a clear recommendation for or against preventive iron supplementation in pregnancy, 2,3 which has been a routine practice for decades, with up to 77% to 89% of patients reporting supplement use. 4 As highlighted previously by the USPSTF and others, there is an urgent need for studies and clinical trials to support evidence-based medicine in the obstetric population, and this can only be accomplished by ceasing paternalistic approaches that have led to the exclusion of pregnant patients in research. [5][6][7][8][9][10][11] All of this remains true, and there is still so very far to go.In the updated USPSTF review, an additional 5 randomized clinical trials (RCTs) were included with the 12 RCTs carried forward from the 2015 review. The USPSTF determined that the availability of good-and fair-quality RCTs was sufficient; observational studies were included only for the association questions. However, it is important to acknowledge that while RCTs provide rigor and purity for evaluating medical interventions, they may not always be the best study design for all clinical questions. Indeed, the many traditional RCT designs and implementation approaches limit real-world applicability, discourage involvement and thus applicability to marginalized and underserved populations, and decrease the likelihood that the effect on rare outcomes such as severe maternal morbidity will be detected. Large, populationbased studies provide additional useful evidence when examining uncommon outcomes with a high impact such as severe maternal morbidity and mortality, transfusion, and death. An RCT examining such rare outcomes may be costprohibitive and thus an ineffective method to approach several aspects of the question at hand.Importantly, it is vital to ensure that the outcomes assessed in studies are physiologically plausible. Some of the outcomes reviewed by the USPSTF, such as gestational diabetes, hypertensive disorders, and cesarean delivery, have been associated with iron deficiency anemia in observational studies but not in RCTs. It is more likely that the association in observational studies was due to confounders such as nutritional status, body mass index, healthy lifestyle choices, socioeconomic status, and systemic racism rather than iron defi-

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“Is It Safe?” — The Many Unanswered Questions about Medications and Breast-Feeding

Cited by 42 publications

References 2 publications

Navigating off‐label and unlicensed medicines use in obstetric and paediatric clinical practice

Navigating off‐label and unlicensed medicines use in obstetric and paediatric clinical practice

Reinvent Motherisk to keep mothers and babies from harm

Anemic Data for Preventive Screening and Supplementation to Address Iron Deficiency Anemia in Pregnancy

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