Dataset Information

Safety profile of medication used during pregnancy: results of a multinational European study.

ABSTRACT:

Purpose

The present study describes the safety profile of medications used during pregnancy across European countries and examines maternal factors associated with the use of risky medications during pregnancy.

Methods

This study is based on a multinational, web-based study conducted in 15 European countries from October 2011 to February 2012. Information about maternal demographics, illnesses, and medication use during pregnancy was collected via an electronic questionnaire. Pregnant women and new mothers with a child less than 1-year-old could participate. The Swedish, Australian, and U.S. risk classification systems were used to evaluate medication safety. Descriptive statistics and generalized estimating equation models were used.

Results

A total of 587 medications were reported by the study sample (n = 6657). Sixty-nine percent of the women used medications classified as safe, 28% used medications classified as risky, and 3% used medications with no classification available. Both socio-demographic and medical factors were associated with the use of risky medications during pregnancy. Having a chronic disorder was the factor with the strongest association with the use of risky medications during pregnancy (adjusted odds ratio = 3.99, 95% confidence interval 3.54-4.49).

Conclusions

The majority of women used medications classified as safe to use during pregnancy. However, a considerable proportion of women still used medications classified as risky. Having a chronic disorder was an important driver for using risky medications. Such use may still be appropriate when considering the woman's underlying condition. Pre-pregnancy counselling is important to ensure safe medication use for both mother and child. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.

SUBMITTER: Tronnes JN

PROVIDER: S-EPMC5518438 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Publications

Safety profile of medication used during pregnancy: results of a multinational European study.

Trønnes Johanne N JN Lupattelli Angela A Nordeng Hedvig H

Pharmacoepidemiology and drug safety 20170427 7

<h4>Purpose</h4>The present study describes the safety profile of medications used during pregnancy across European countries and examines maternal factors associated with the use of risky medications during pregnancy.<h4>Methods</h4>This study is based on a multinational, web-based study conducted in 15 European countries from October 2011 to February 2012. Information about maternal demographics, illnesses, and medication use during pregnancy was collected via an electronic questionnaire. Preg ...[more]

PMID: 28449197

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Project description:Intercountry comparability between studies on medication use in pregnancy is difficult due to dissimilarities in study design and methodology. This study aimed to examine patterns and factors associated with medications use in pregnancy from a multinational perspective, with emphasis on type of medication utilised and indication for use.Cross-sectional, web-based study performed within the period from 1 October 2011 to 29 February 2012. Uniform collection of drug utilisation data was performed via an anonymous online questionnaire.Multinational study in Europe (Western, Northern and Eastern), North and South America and Australia.Pregnant women and new mothers with children less than 1 year of age.Prevalence of and factors associated with medication use for acute/short-term illnesses, chronic/long-term disorders and over-the-counter (OTC) medication use.The study population included 9459 women, of which 81.2% reported use of at least one medication (prescribed or OTC) during pregnancy. Overall, OTC medication use occurred in 66.9% of the pregnancies, whereas 68.4% and 17% of women reported use of at least one medication for treatment of acute/short-term illnesses and chronic/long-term disorders, respectively. The extent of self-reported medicated illnesses and types of medication used by indication varied across regions, especially in relation to urinary tract infections, depression or OTC nasal sprays. Women with higher age or lower educational level, housewives or women with an unplanned pregnancy were those most often reporting use of medication for chronic/long-term disorders. Immigrant women in Western (adjusted OR (aOR): 0.55, 95% CI 0.34 to 0.87) and Northern Europe (aOR: 0.50, 95% CI 0.31 to 0.83) were less likely to report use of medication for chronic/long-term disorders during pregnancy than non-immigrants.In this study, the majority of women in Europe, North America, South America and Australia used at least one medication during pregnancy. There was a substantial inter-region variability in the types of medication used.

Project description:BackgroundThe use of complementary and alternative medicines (CAM) is growing in the general population. Herbal medicines are used in all countries of the world and are included in the top CAM therapies used.MethodsA multinational study on how women treat disease and pregnancy-related health ailments was conducted between October 2011 and February 2012 in Europe, North and South America and Australia. In this study, the primary aim was to determine the prevalence of herbal medicine use in pregnancy and factors related to such use across participating countries and regions. The secondary aim was to investigate who recommended the use of herbal medication in pregnancy.ResultsThere were 9,459 women from 23 countries participating in the study. Of these, 28.9% reported the use of herbal medicines in pregnancy. Most herbal medicines were used for pregnancy-related health ailments such as cold and nausea. Ginger, cranberry, valerian and raspberry were the most commonly used herbs in pregnancy. The highest reported rate of herbal use medicines was in Russia (69%). Women from Eastern Europe (51.8%) and Australia (43.8%) were twice as likely to use an herbal medicine versus other regions. Women using herbal medicines were characteristically having their first child, non-smokers, using folic acid and consuming some alcohol in pregnancy. Also, women who were currently students and women with an education other than a high school degree were more likely to use herbal medicines than other women. Although 1 out of 5 women stated that a physician had recommended the herbal use, most women used herbal medicine in pregnancy on their own initiative.ConclusionsIn this multinational study herbal medicine use in pregnancy was high although there were distinct differences in the herbs and users of herbal medicines across regions. Most commonly the women self-medicated with herbal medicine to treat pregnancy-related health ailments. More knowledge regarding the efficacy and safety of herbal medicines in pregnancy is warranted.

Project description:BackgroundPatients with rheumatoid arthritis (RA) have an increased risk of infection and malignancy compared with the general population. Infection risk is increased further with the use of disease-modifying antirheumatic drugs (DMARDs), whereas evidence on whether the use of biologic DMARDs increases cancer risk remains equivocal. This single-arm, post-marketing study estimated the incidence of prespecified infection and malignancy outcomes in patients with RA treated with intravenous or subcutaneous abatacept.MethodsData were included from seven European RA quality registries: ATTRA (Anti-TNF Therapy in Rheumatoid Arthritis [Czech Republic]), DANBIO (Danish Rheumatologic Database), ROB-FIN (National Registry of Antirheumatic and Biological Treatment in Finland), ORA (Orencia and Rheumatoid Arthritis [France]), GISEA (Italian Group for the Study of Early Arthritis), BIOBADASER (Spanish Register of Adverse Events of Biological Therapies in Rheumatic Diseases), and the SCQM (Swiss Clinical Quality Management) system. Each registry is unique with respect to design, data collection, definition of the study cohort, reporting, and validation of outcomes. In general, registries defined the index date as the first day of abatacept treatment and reported data for infections requiring hospitalization and overall malignancies; data for other infection and malignancy outcomes were not available for every cohort. Abatacept exposure was measured in patient-years (p-y). Incidence rates (IRs) were calculated as the number of events per 1000 p-y of follow-up with 95% confidence intervals.ResultsOver 5000 patients with RA treated with abatacept were included. Most patients (78-85%) were female, and the mean age range was 52-58 years. Baseline characteristics were largely consistent across registries. Among patients treated with abatacept, IRs for infections requiring hospitalization across the registries ranged from 4 to 100 events per 1000 p-y, while IRs for overall malignancy ranged from 3 to 19 per 1000 p-y.ConclusionsDespite heterogeneity between registries in terms of design, data collection, and ascertainment of safety outcomes, as well as the possibility of under-reporting of adverse events in observational studies, the safety profile of abatacept reported here was largely consistent with previous findings in patients with RA treated with abatacept, with no new or increased risks of infection or malignancy.

Dataset Information

Safety profile of medication used during pregnancy: results of a multinational European study.

Purpose

Methods

Results

Conclusions

Publications

Safety profile of medication used during pregnancy: results of a multinational European study.

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