Safe lists for medications in pregnancy

medications and pregnancy/pregnant','prescriptiondrugs and pregnancy','medications and pregnancyand safe','medications safe to take during preg-nancy','prescription drugs safe during pregnancy',and'prescription drugs ok to take while pregnant'. Medication names were abstracted and compared across sites. Vitamins, herbals, intravenous medications, and topical cutaneous medications were excluded from the analysis, and equivalent medications (e.g., acyclovir and valacyclovir) were combined. Components of over-the-counter (OTC) and prescription medications listed as ' safe ' by any source were searched in the Teratogen Information System (TERIS), 5 and frequencies were tabulated by risk rating. TERIS is a database housing expert assessments of the terato- genic risk of medications in human pregnancy after exposure under usual conditions. The magnitude of risk is categorized as none, unlikely, minimal, small, moderate, high, or undetermined (http://depts. washington.edu/terisweb/teris/). Published clinical, experimental, and epidemiologic literature is used to determine the risk rating, and a data quality and quantity score ranging from none to excellent is also assigned. Given that this study was conducted solely using Internet sources and an electronic database, the study was deemed not to constitute human subjects research. RESULTS The environmental scan identi fi ed ' safe medication ' lists from 28 sources. Of these, 26 were still available in September 2011; upon further veri fi ca- tion of website data in August 2012 at the journal ' s request, one additional site was excluded as the current information was inconsistent with that gath- ered in the initial search. Analyses were restricted to this subset of 25, which included three medical, one professional organization, four pregnancy infor- mation, and 17 clinical practice sources (Table 1). Only three lists displayed references, and only one of these (Netdoctor) provided references from peer-reviewed scienti fi c literature. From the 25 lists (none of which were identical), a total of 245 med- ication products were identi fi ed as ' safe ' for use by pregnant women. Eight of the 25 lists offered some type of safety de fi nition, two of which de fi ned it in the context of the medication not having been shown to cause birth defects, and two others de- fi ned safety based on the Food and Drug Adminis- tration use in pregnancy labels (categories A – X). 6 There was a mean of 34 medication products per list. Twenty-two (9%) of the products listed as safe byoneormoresiteswerestatednottobesafeby one or more of the other sites (Table 2). The active components from each product were identi fi ed, and duplicate components (e.g., acetaminophen from multiple acetaminophen-containing products) were removed, resulting in 164 unique components that were included in the analysis. After applying the exclusion criteria noted in the methods, TERIS was searched for the remaining 114 components, of which 103 (90%) had existing evaluations. None had a small, moderate, or high risk rating (Figure 1). Seven components (7%) of 103 were rated as having no risk; three (3%) had a ' none to minimal ' risk rating; one (1%) was rated as posing a minimal risk (pseudoephedrine); 49 (48%) were rated as unlikely to pose a risk; and 43 (42%) were of undetermined risk. Regardless of risk rating, 42 components were given a data quality and quantity score of none to limited, 40 (95%) of which corresponded with ' un- determined ' risk ratings (data not shown). At the other end of the scale, only 7% of the components had data quality and quantity scores ranging from good to excellent. Of interest, among the four med- ication components with TERIS risk ratings of either ' none to minimal ' or ' minimal ' (erythromycin, metronidazole, phenylephrine, and pseudoephedrine), all had data quality and quantity scores ranging only from fair to good. Only 13 (52%) of the websites encouraged consulta- tion with a healthcare provider before stopping or starting a medication during pregnancy, and less than half (40%) recommended taking medications during pregnancy only when necessary. DISCUSSION This report identi fi es inconsistencies in publicly available information on the safety of medications during pregnancy and shows that a large proportion of currently available information for products fre- quently used in pregnancy lacks data to support safety claims. Although it is reassuring that no medications from any identi fi ed ' safe ' lists had evi- dence suggesting a moderate or high teratogenic risk, it was often the case that these medications had an as yet undetermined teratogenic risk; there- fore, caution is advised in interpreting the majority of these medications as ' safe ' for use during preg- nancy. The existence of lists purporting safety might encourage use of medications during preg- nancy even when they are not necessary. s. l. peters et al. Copyright © 2013 John Wiley & Sons, Ltd. Pharmacoepidemiology and Drug Safety , (2013) DOI: 10.1002/pds Only three of the 25 sites surveyed provided references or source material to support their claims of safety, and only half of the included websites encouraged consulta- tion with a healthcare provid er about medication use during pregnancy. This means many websites lack a critical message that should be paramount in any website that provides information t o pregnant women. However, given the limited availability of human data on the terato- genic risks associated with most medications, 4 healthcare providers frequently also do not have the information needed to provide informed guidance to their patients. The proportion of women who take medication dur- ing pregnancy has increased by 60% since the 1970s, as has the average number of medications pregnant women take. 3 These trends can be accounted for, at least inpart,byincreasingmaternalage 7 and concomitant comorbidities that often require treatment. Both OTC and prescription use is high (70 – 80% of women report taking at least one medication) during the fi rst trimester of pregnancy, 3 a critical period for embryonic develop- ment during which the potential for teratogenic risk may be of greatest concern. The prevalence of unintended pregnancy (nearly 50%) in the USA 8 also contributes to inadvertent medication exposures in the critical time period before pregnancy recognition. This analysis excluded herbal/dietary supplements because these products often have an uncertain safety pro fi le given the absence of data. Use of herbal products is relatively common, with nearly 10% of women reporting exposures at some point Table 1. Evaluated lists grouped by website type and including number of medications listed as ' safe ' for use during pregnancy — Active, August 2012 Website type Source name URL Medication products* ( N ) Medical site Livestrong http://www.livestrong.com/article/26729-list-safe-otc-medications-pregnancy/ 8 Netdoctor http://www.netdoctor.co.uk/health_advice/facts/medicinesinpregnancy.html 15 OBFocus http://www.obfocus.com/high-risk/medsprint.htm 51 Professional organization American College of Nurse – Midwives http://www.midwife.org/documents/TakingMedicineDuringPregnancy52-5.pdf 16 Pregnancy information BabyCenter http://www.babycenter.com/0_chart-over-the-counter-medications-during- pregnancy_1486462.bc 54 Dr. Lera http://drlera.com/health_beauty/healthy_baby/Medications_for_Pregnant_Women. htm 39 She Knows, Pregnancy & Baby http://www.pregnancyandbaby.com/pregnancy/articles/945667/medications- during-pregnancy-list-of-safe-and-unsafe-drugs 7 Pregnancy etc. http://www.pregnancyetc.com/what-are-some-safe-medications-to-take-during- pregnancy.htm 37 Clinical practice Bend OBGYN http://www.bendobgyn.net/Safe_Medications_When_Pregnant.htm?m=45&s=39 30 Boojum OBGYN http://www.drkells.com/Medication.pdf 35 Budge Clinic OBGYN http://intermountainhealthcare.org/services/medicalgroup/clinics/physicianclinics/ budgeobgyn/Documents/Medications_While_Pregnant.pdf 21 Diamond Women ' s Center http://www.diamondobgyn.com/Groups/1000050633/Diamond_Womens_Center/ Early_Life_Services/Pregnancy_Info/General_Medication_Use/ General_Medication_Use.aspx 34 Fayetteville Woman ' s Care http://www.fwc.net/expecting-mothers/safe-meds-during-pregnancy 40 Kristin Miller OBGYN http://www.kristinmillermd.com/forms/obMedications.pdf 43 Mercy OBGYN http://mercyobgyn.com/docs/medicationapprovedduringpregnancy.pdf 20 Midtown OBGYN http://www.mymidtownobgyn.com/PDFDocuments/SAFEMedicationList.pdf 68 Oakwood Women ' s Center http://www.oakwoodwomens.com/ fi les/safe_meds_list.pdf 25 OBGYN Centers for Family Health http://drmsg.com/new_page_2.htm 18 Paci fi c Regional Medical Army Medical Center OBGYN http://www.tamc.amedd.army.mil/of fi ces/obgyn/PregnancyMedications.htm 18 Providence Health and Services http://www.providence.org/Oregon/health_resource_centers/Pregnancy_Center/ Medication.htm 23 Seasons Healthcare for Women http://www.seasonshealthcare4women.com/docs/SafeMedicationsInPregnancy.pdf 34 Women ' s Health Specialists of Fremont http://www.womenshealthfremont.com/webdocuments/medications-in-pregnancy.pdf 77 OBGYN Women ' s Physicians Assoc. http://www.womendoctor.com/pdf/preg_meds.pdf 65 Obstetrical Associates, Inc. http://oba-ma.com/Medications.html 27 Women ' s Health Consultants http://www.whcobgyn.com/Medication_List.pdf 44 *The total number of medication products is at least that listed in the table — some sites listed a group of similar products as ' safe ' , such as, Tylenol W products. web safe lists for medications in pregnancy Copyright © 2013 John Wiley & Sons, Ltd. Pharmacoepidemiology and Drug Safety , (2013) DOI: 10.1002/pds during pregnancy. 9 Substances marketed as natural products can be incorrectly perceived as harmless to both a pregnant woman and her developing fetus, even though no evidence of safety (or risk) exists. 10 In fact, herbal and dietary products are less studied than prescription medications prior to marketing. Under the Dietary Supplement Health and Education Act, the Food and Drug Administration can take regulatory action against a supplement only if the agency can prove that a marketed supplement is unsafe, and post-marketing safety concerns have emerged for sev- eral products. 9,11 Similarly, a product ' s availability as OTC does not necessarily mean that it is ' safe ' for use during pregnancy. However, one of the factors considered prior to designation of (or switch to) OTC status is the potential for risk if taken during pregnancy (or taken by women of reproductive potential). Furthermore, these products tend to have multiple active ingredients, which complicate the character- ization of risks associated with their use. This environmental scan evaluated all Internet sources that could be identi fi ed during the period November 2010 – September 2011 and that could be veri fi ed as of August 2012. The analysis used an existing independent re source to evaluate the evidence base for the medications deemed to be ' safe ' for use during pregnancy. Assumptions had to be made about the exact nature of some of the medications because of the unclear terminology used in the ' safe ' lists. In addition, for most medications, these websites did not specify dosage, routes, or timing of exposure in pregnancy, which can be critical factors in assessing safety. 12 The fi ndings in this report are subject to several limitations. First, while no two lists were identical, some lists might have borrowed from other existing lists. Thus, the sources are not likely to be com- pletely independent. Second, because only English language sources were evaluated, this environmental scan probably underestimates the diversity of avail- able Internet sources on this topic and may underes- timate the inconsistency that exists. Third, this environmental scan did not include paper lists that may be distributed by prenatal care providers or other non-Internet sources. Finally, the investigators were unable to determine the frequency of use of the included websites. The implications of inaccu- rate guidance probably depend on which sites are most frequently visited. Women or healthcare providers relying on Inter- net sources of information on ' safe ' medications for use in pregnancy may be inappropriately reassured because many medications listed as ' safe ' lack evidence that actually demonstrates safety. The wide availability of ' safe ' medication lists suggests Table 2. Medications listed as ' safe ' for use in pregnancy by one or more websites and ' unsafe ' by one or more other sites Cold/ fl u/allergy Actifed W (chlorpheniramine and phenylephrine) Afrin W (oxymetazoline) Claritin-D W (loratadine and pseudoephedrine) Chlor-Trimeton W (chlorpheniramine) Dimetapp W (brompheniramine and pseudoephedrine) Diphenhydramine Loratadine Phenylephrine Pseudoephedrine Thera fl u W (acetaminophen, pheniramine, and phenylephrine) Zyrtec-D W (cetirizine and pseudoephedrine) Pain relief Acetaminophen (extra strength) Codeine Constipation Dulcolax W (bisacodyl) Surfak W (docusate calcium) Vaginal yeast infection Gyne-Lotrimin W (clotrimazole) Heartburn Rolaids W (calcium carbonate and magnesium hydroxide) Upset stomach/nausea Bismuth subsalicylate Insomnia Unisom W (SleepTabs: doxylamine; SleepGels/SleepMelts: diphenhydramine) Anticholinergic Scopolamine Antidiarrheal Loperamide Antifungal Lamisil W (terbina fi ne) Trade/generic names are listed as provided by the websites, with generic components provided in parentheses for completeness. Figure 1. Frequency distribution of Teratogen Information System (TERIS) risk ratings for 103 medications listed as safe for use in pregnancy by one or more of the websites s. l. peters et al. Copyright © 2013 John Wiley & Sons, Ltd. Pharmacoepidemiology and Drug Safety , (2013) DOI: 10.1002/pds

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