Use of over-the-counter medications during pregnancy
ABSTRACT The most common medications used in pregnancy are nonprescription or over-the-counter medications, although there has been little research on their risks or safety. We describe the patterns of over-the-counter medication use among pregnant women.
Data were collected in 2 case-control studies of birth defects: the Slone Epidemiology Center Birth Defects Study (BDS) and the National Birth Defects Prevention Study (NBDPS).
Among 7563 mothers of malformed and nonmalformed offspring in the Slone Epidemiology Center Birth Defects Study and 2970 mothers of nonmalformed offspring in the National Birth Defects Prevention Study, acetaminophen, ibuprofen, and pseudoephedrine were used by at least 65%, 18%, and 15%, respectively. Among women in the Slone Epidemiology Center Birth Defects Study, the use in pregnancy of aspirin and chlorpheniramine decreased from 1976 to 2004 and of ibuprofen, pseudoephedrine, diphenhydramine, dextromethorphan, and guaifenesin increased. Among women in the National Birth Defects Prevention Study, the use of acetaminophen, pseudoephedrine, diphenhydramine, and guaifenesin was higher during pregnancy than before pregnancy.
Findings show that over-the-counter medications are used by most pregnant women. Studies that examine specific over-the-counter medications in relation to specific birth defects are necessary to better inform pregnant women about risks and safety.
- SourceAvailable from: Heiko Udo Käfferlein
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- "Paracetamol has been widely used as first-line treatment of fever and pain during pregnancy since other over-the-counter pain relievers such as ibuprofen or acetylsalicylic acid are not considered to be safe for pregnant women. 20–75% of women have been reported to use such medications at least once during pregnancy (Werler et al., 2005; Thiele et al., 2013). "
ABSTRACT: Abstract Epidemiological studies suggest associations between the use of N-acetyl-4-aminophenol (paracetamol) during pregnancy and increased risks of reproductive disorders in the male offspring. Previously we have reported a ubiquitous urinary excretion of N-acetyl-4-aminophenol in the general population. Possible sources are (1) direct intake of paracetamol through medication, (2) paracetamol residues in the food chain and (3) environmental exposure to aniline or related substances that are metabolized into N-acetyl-4-aminophenol. In order to elucidate the origins of the excretion of N-acetyl-4-aminophenol in urine and to contribute to the understanding of paracetamol and aniline metabolism in humans we developed a rapid, turbulent-flow HPLC-MS/MS method with isotope dilution for the simultaneous quantification of N-acetyl-4-aminophenol and two other aniline related metabolites, N-acetyl-2-aminophenol and acetanilide. We applied this method to three sets of urine samples: (1) individuals with no known exposure to aniline and also no recent paracetamol medication; (2) individuals after occupational exposure to aniline but no paracetamol medication and (3) paracetamol users. We confirmed the omnipresent excretion of N-acetyl-4-aminophenol. Additionally we revealed an omnipresent excretion of N-acetyl-2-aminophenol. In contrast, acetanilide was only found after occupational exposure to aniline, not in the general population or after paracetamol use. The results lead to four preliminary conclusions: (1) other sources than aniline seem to be responsible for the major part of urinary N-acetyl-4-aminophenol in the general population; (2) Acetanilide is a metabolite of aniline in man and a valuable biomarker for aniline in occupational settings; (3) aniline baseline levels in the general population measured after chemical hydrolysis do not seem to originate from acetanilide and hence not from a direct exposure to aniline itself; (4) N-acetyl-2-aminophenol does not seem to be related to aniline nor to N-acetyl-4-aminophenol in man.International Journal of Hygiene and Environmental Health 04/2014; 217(4-5):592–599. DOI:10.1016/j.ijheh.2013.11.005 · 3.28 Impact Factor
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- "(Black and Hill, 2003). Especially APAP ranks at the top of medication taken by pregnant women, although numbers vary between studies from 20% to 75% (Werler et al., 2005; Table 1). These variations may be explained by study sizes and participant clientele, but large studies (n > 10.000) support that the frequency of pregnant women taking APAP at least once during pregnancy is as high as 20–30%. "
ABSTRACT: Counter-intuitively, over-the-counter medication is commonly taken by pregnant women. In this context, acetaminophen (APAP, e.g. Paracetamol, Tylenol) is generally recommended by physicians to treat fever and pain during pregnancy. Thus, APAP ranks at the top of the list of medications taken prenatally. Insights on an increased risk for pregnancy complications such as miscarriage, stillbirth, preterm birth or fetal malformations upon APAP exposure are rather ambiguous. However, emerging evidence arising from human trials clearly reveals a significant correlation between APAP use during pregnancy and an increased risk for the development of asthma in children later in life. Pathways through which APAP increases this risk are still elusive. APAP can be liver toxic and since APAP appears to freely cross the placenta, therapeutic and certainly toxic doses could not only affect maternal, but also fetal hepatocytes. It is noteworthy that during fetal development, the liver transiently functions as the main hematopoietic organ. We here review the effect of APAP on metabolic and immunological parameters in pregnant women and on fetal development and immune ontogeny in order to delineate novel, putative and to date underrated pathways through which APAP use during pregnancy can impair maternal, fetal and long term children's health. We conclude that future studies are urgently needed to reconsider the safety and dosage of APAP during pregnancy and - based on the advances made in the field of reproduction as well as APAP metabolism - we propose pathways, which should be addressed in future research and clinical endeavors.Journal of Reproductive Immunology 03/2013; 97(1):128-39. DOI:10.1016/j.jri.2012.10.014 · 2.37 Impact Factor
- "The evidence, though inconclusive, suggesting moderately increased risks of vascular disruption defects, should raise concern and prompt further research. In the meantime, it would be prudent to advise women that pseudoephedrine may not be safe to take in pregnancy, as has been practiced by some clinicians (Werler et al., 2005). Use of pseudoephedrine may begin to decrease, as access has recently been restricted in several states, either requiring a prescription or being dispensed from behind the counter. "
Article: Teratogen update: Pseudoephedrine[Show abstract] [Hide abstract]
ABSTRACT: Pseudoephedrine is contained in decongestants such as the Sudafed line of products. It is an alpha-adrenergic receptor agonist, which causes blood vessel constriction, including the therapeutic effect of reducing airflow resistance in the nasal cavity. Pseudoephedrine is one of the most commonly used medications in pregnancy, with an estimated 25% of women exposed. It has been demonstrated that alpha-adrenergic receptor agonists slow uterine blood flow, but their effects have not been studied in relation to most reproductive outcomes in animals or humans. Two analyses of health maintenance organization pharmacy data identified 9 malformed infants among 902 first-trimester pseudoephedrine exposures, suggesting no association with birth defects overall; however, studies of such data sets often lack sufficient power to identify risks for specific birth defects. The related compounds, epinephrine, ephedrine, and phenylephrine, have been associated with hemorrhages and cardiovascular and limb malformations in animal models. Risk of ventricular septal defects was associated with decongestant use in pregnant women in 1 recent study. The vasoconstrictive effects of these drugs raise the hypothesis that their use in early pregnancy might increase the risk of vascular disruption defects. Case-control studies, which often do have power to identify risks related to specific birth defects, have explored this hypothesis. Decongestant use in the first trimester has been associated with small increases in risks of 3 defects thought to arise, at least in some instances, from vascular disruption-gastroschisis, small intestinal atresia, and hemifacial microsomia. These findings are somewhat consistent in terms of magnitude of effect and suggest that risks are even greater among women also exposed to the vasoconstrictive effects of cigarette smoking. There are, however, limitations to these studies, including the possibilities of inaccurate recall of exposures and confounding by indication. In addition, the majority of decongestant use is in oral form and the question of whether intranasal formulations carry risk has not been adequately addressed.Birth Defects Research Part A Clinical and Molecular Teratology 06/2006; 76(6):445-52. DOI:10.1002/bdra.20255 · 2.21 Impact Factor