OTC Medication Use in Pregnancy and Breastfeeding

Seema H. Ledan, PharmD

Disclosures

US Pharmacist. 2019;44(9):16-19. 

In This Article

Abstract and Introduction

Abstract

In the United States, 90% of females take a form of medication during their pregnancy. However, for ethical reasons, most clinical trials do not include pregnant and lactating women; hence, limited evidence is available to help evaluate the use of medications during pregnancy or lactation. Some medications may pose a safety risk, and careful consideration should be made regarding those that have been shown to cause birth defects or complications during labor, have long half-lives, or accumulate in breast milk in large amounts.

Introduction

In the United States, over 90% of women take a form of medication during their pregnancy.[1] However, for ethical reasons, a majority of clinical trials do not include pregnant women; therefore, limited evidence is available to help evaluate the use of medications during pregnancy.[2–6] With the first trimester being a crucial part of the development of major organs in the fetus and when most birth defects are likely to happen, careful use of medications is recommended. However, some women are not aware of their pregnancy prior to medication consumption in the early stages.

A CDC study identified the most common medications used in the first trimester, with acetaminophen, ibuprofen, docusate, pseudoephedrine, aspirin, and naproxen being the most typically used OTC medications.[7] With the increase of OTC- and prescription-drug use, providers, pharmacists, and the Internet have become valuable sources in determining whether a medication is safe to take. Given the risks of birth defects, prematurity, infant death, pregnancy loss, and various other complications, judicious use may be recommended. However, available resources have increased over the years due to the growing use of medications.[8,9]

In addition, some of these situations, such as pain or constipation, may still exist after the baby is born, raising questions about whether it is safe to take a medication while breastfeeding. Similar to safe medication use in pregnancy, treating conditions when breastfeeding has comparable challenges, such as safety to the baby and mother, effect on lactation supply, and the limited available supporting evidence.[5,10] Some medications may pose a safety risk, and careful consideration should be made for those with long half-lives or those that accumulate in breast milk in large amounts, and also for infants who are more prone to side effects (e.g., preterm, neonates, underlying medical conditions).[11]

Available Resources

With 2% to 3% of birth defects being due to medication use, drug labels or package inserts are required to provide guidance on the use of drugs during pregnancy and lactation.[12] Although the number of medications that are known to cause birth defects is small, these medications may also be limited to prescription-drug products. In 2015, the FDA updated the former pregnancy categories on prescription and biological drug labels to a more narrative summary, requiring providers to review the available evidence before making a clinical decision on whether a medication may be safe to take during pregnancy and lactation.[13] However, the labeling of OTC medications and the categories that help evaluate safety risk are unchanged. Outside of the FDA labels, a vast number of resources are available to help determine whether a medication is safe (Table 1).[1,14–20]

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