US Pharm. 2019;44:9):16-19
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
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
Commonly Treated Conditions Pain and Headache
Studies show that pain is the most treated condition during pregnancy and postpregnancy.3 However, with the wide variety of OTC options for pain, only a few are recommended.
Acetaminophen (Tylenol) has demonstrated efficacy and safety at all stages of pregnancy when used at recommended therapeutic doses and for short-term use.15-17,21,22 Adverse pregnancy outcomes or abnormalities are not commonly seen with the use of acetaminophen. However, recent data have shown potential risks with prenatal acetaminophen use, such as asthma, lower performance intelligence quotient, neurodevelopmental problems, poorer attention, and behavioral problems in childhood.22 Yet, acetaminophen is still a safer option for pain or fever in pregnancy and should be used only when needed at recommended doses.22 In addition, it has been deemed safe for use in lactating women, with the amount in breast milk actually less than the dose typically given to an infant for fever or pain.14,23
Nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin), naproxen (Aleve), or aspirin are not recommended during the last 3 months of pregnancy due to an increase in blood flow and bleeding complications in the mother and baby during pregnancy and at delivery.15-17,21 However, ibuprofen is actually one of the preferred choices for pain/fever in breastfeeding mothers because of its low levels in breast milk and short half-life.1 Aspirin and naproxen are not preferred for breastfeeding due to longer half-lives and reported serious adverse reactions. It is important to note that combination acetaminophen/aspirin/caffeine (Excedrin) for headache may not be considered safe due to effects that aspirin and caffeine have on the growing fetus as well as the infant.
Nausea and Vomiting
Nausea and vomiting are the most common gastrointestinal complications in pregnant women. This may affect quality of life not only in the beginning of the pregnancy; in some women, the condition may impact much of their term. Multiple treatment options are available and may be considered safe during certain trimesters of pregnancy, and the majority of options are prescription medications. Common OTC products that are recommended and proven to be safe are vitamin B6 and ginger root.24 The American College of Obstetricians and Gynecologists and the American Family Physician recommend a combination of vitamin B6 (10-25 mg every 8 hours) and doxylamine (Unisom) (12.5-25 mg every 8 hours) to help reduce nausea and vomiting in the first trimester.25,26 This combination therapy may help decrease nausea and vomiting by 70%.
Due to physiological and anatomic changes in the gastrointestinal tract, constipation may occur in up to 38% of pregnant women, making it the second most common gastrointestinal disturbance.27 Fluids, dietary fiber, and exercise can help relieve constipation; however, alternatives such as probiotics or laxatives may be needed to achieve additional relief. Many laxatives are considered safe during pregnancy, with their own characteristics that may deter long-term use or monitoring for side effects.27,28 Osmotic laxatives such as polyethylene glycol may cause flatulence and bloating but may be considered one of the preferred agents during pregnancy.
Stimulant laxatives such as senna may cause abdominal cramps and are limited to short-term use. Overuse of senna may cause the bowels to not function properly and may create dependency on the stimulant; routine use is not recommended and is limited to a last-line option for no more than 1 week.29 Lubricants such as mineral oil should be avoided due to hemorrhage and absorption reduction of fat-soluble vitamins with long-term use. For breastfeeding mothers, laxatives that are not absorbed from the gastrointestinal tract, such as docusate, senna, and psyllium, cannot enter the breast milk and are preferred for short-term use.14,28
Cough and Cold
Mild upper-respiratory illnesses and the common cold are caused by viruses that are self-limiting; therefore, OTC medications are heavily relied on for symptoms and quality-of-life improvement.30 Many of the OTC medications contain only a few ingredients; however, these products may not be the safest options in breastfeeding mothers. TABLE 2 provides a summary of the pregnancy and lactation recommendations for these products.
With changes in hormone levels and the increase in glycogen in vaginal secretions, yeast infections are common in pregnancy, especially in the second trimester. Topical azoles such as miconazole (Monistat) are the therapy of choice due to safety data collected in humans.31 Therapy is recommended for 7 days, and shorter treatment duration does not show success.31 Probiotics, such as lactobacillus and bifidobacterium, may also be used to treat yeast vaginosis, and they have not been reported to cause adverse fetal outcomes.32 It is crucial to combat these infections, as they can pass to the baby’s mouth if left untreated during delivery, causing thrush in newborns.
If a yeast infection does occur while breastfeeding, topical azoles and probiotics (i.e., lactobacillus) are deemed safe and recommended; transfer to breast milk is unlikely.14,32
Role of the Pharmacist
Pharmacists are often the main resource contacted by a patient or a healthcare professional to verify whether a medication is safe to take during pregnancy or lactation. Community pharmacists, specifically, could be the first line of contact or the last professional seen by a patient.33 Reviewing available resources and clinical evidence is vital in order to make a sound decision on safety and efficacy for a pregnant or breastfeeding woman.
While medication use during pregnancy has increased over the years, judicious use is strongly recommended at any stage of pregnancy or the lactation period due to safety, limited supporting evidence, and adverse events such as a decrease in milk production. Although the majority of OTC medications have been deemed safe, there are still some common products that could potentially cause harm to the growing fetus, cause problems during labor, or decrease milk production. Requesting information or recommendations from providers or pharmacists, researching safety with available resources, and evaluating whether therapy is truly needed during pregnancy or lactation should be done with any medication, including OTC products.
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