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      Adverse drug reactions from psychotropic medicines in the paediatric population: analysis of reports to the Danish Medicines Agency over a decade

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      BMC Research Notes
      BioMed Central

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          Abstract

          Background

          The prescribing of psychotropic medicines for the paediatric population is rapidly increasing. In attempts to curb the use of psychotropic medicine in the paediatric population, regulatory authorities have issued various warnings about risks associated with use of these products in childhood. Little evidence has been reported about the adverse drug reactions (ADRs) of these medicines in practice. As spontaneous reports are the main source for information about previously unknown ADRs, we analysed data submitted to a national ADR database. The objective was to characterise ADRs reported for psychotropic medicines in the Danish paediatric population over a decade.

          Findings

          All spontaneous ADR reports from 1998 to 2007 for children from birth to 17 years of age were included. The unit of analysis was one ADR. We analysed the distribution of ADRs per year, seriousness, age and gender of the child, suspected medicine and type of reported ADR. A total of 429 ADRs were reported for psychotropic medicines and 56% of these were classified as serious. Almost 20% of psychotropic ADRs were reported for children from birth up to 2 years of age and one half of ADRs were reported in adolescents, especially for antidepressants and psychostimulants. Approximately 60% of ADRs were reported for boys. Forty percent of all ADRs were from the category 'nervous and psychiatric disorders'. All but one ADR reported for children below two years were serious and two of these were fatal. A number of serious ADRs reported in children from birth up to 2 years of age were presumably caused by mothers' use of psychotropic medicines during pregnancy.

          Conclusion

          The high number of serious ADRs reported for psychotropic medicines in the paediatric population should be a concern for health care professionals and physicians. Considering the higher number of birth defects being reported greater care has to be given while prescribing these drugs for pregnant women.

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          Most cited references13

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          Maternal use of selective serotonin reuptake inhibitors and risk of congenital malformations.

          Human data on the teratogenicity of selective serotonin reuptake inhibitors (SSRIs) are limited. We examined the association between SSRI use during early pregnancy and the risk of congenital malformations in the offspring. In a population-based cohort study from Denmark, we identified 1051 women who filled prescriptions for SSRIs from 30 days before conception to the end of the first trimester; of those, 453 filled the prescription during the second or third pregnancy month. We included 150,780 women with no SSRI prescriptions as a reference cohort. Drug use data were extracted from prescription databases. Data on congenital malformations and potential confounders were extracted from hospital discharge registries and the National Birth Registry. The 150,780 women with no SSRI prescriptions gave birth to 5112 (3.4%) children with congenital malformations. The 1051 women with SSRI prescriptions any time during early pregnancy gave birth to 51 (4.9%) children with congenital malformations. The corresponding adjusted relative risk (aRRs) was 1.34 (95% confidence interval = 1.00-1.79). The 453 women with prescriptions during the second or third month of pregnancy gave birth to 31 (6.8%) children with congenital malformations. The corresponding aRR was 1.84 (1.25-2.71). We found an increased risk of congenital malformations after exposure to SSRIs in early pregnancy. It is unclear whether the effects were causal or due to factors related to the underlying disease. There was no evidence that the association was specific to particular malformations.
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            Selective serotonin reuptake inhibitor exposure in utero and pregnancy outcomes.

            To investigate the effect of intrauterine selective serotonin reuptake inhibitor (SSRI) exposure on pregnancy outcomes. Prospective cohort study. Department of Obstetrics, Aarhus University Hospital, Aarhus, Denmark. Pregnant women receiving prenatal care in our hospital from 1989 to 2006. Maternal SSRI use during pregnancy. Gestational age, birth weight, head circumference, 5-minute Apgar score, and admission to the neonatal intensive care unit. Three hundred twenty-nine pregnant women reported treatment with SSRIs, 4902 were not treated with SSRIs but had a history of psychiatric illness, and 51 770 reported no history of psychiatric illness. Gestational age was 5 days (95% confidence interval [CI], -6 to -3) shorter and the odds ratio (OR) for preterm birth was 2.0 (95% CI, 1.3-3.2) in the women exposed to SSRIs compared with women with no history of psychiatric illness. In utero-exposed newborns had increased risk of admission to the neonatal intensive care unit (OR, 2.4; 95% CI, 1.7-3.4) and of 5-minute Apgar scores of less than 8 (OR, 4.4; 95% CI, 2.6-7.6) compared with those not exposed. Head circumference and birth weight did not differ between infants in the exposed and unexposed groups. The results were similar when compared with infants of women with a psychiatric history. Exposure to SSRIs during pregnancy was associated with an increased risk of preterm delivery, a low 5-minute Apgar score, and neonatal intensive care unit admission, which was not explained by lower Apgar scores or gestational age. The study justifies increased awareness to the possible effects of intrauterine exposure to antidepressants.
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              Adverse drug reactions in the paediatric population in Denmark: a retrospective analysis of reports made to the Danish Medicines Agency from 1998 to 2007.

              The potential risk of adverse drug reactions (ADRs) in the paediatric population has become a public health concern and regulatory agencies in Europe and the US have acknowledged that there is a need for more research in this area. Spontaneous reporting systems can provide important new information about ADRs. To characterize ADRs in children reported in Denmark over a period of one decade. We analysed ADRs reported to the Danish Medicines Agency from 1998 to 2007 for individuals aged from birth to 17 years. Data were analysed with respect to time, age and sex, category of ADR (System Organ Class [SOC]), seriousness, suspected medicines (level 2 of the Anatomical Therapeutic Chemical [ATC] Classification System) and type of reporter. 2437 ADR reports corresponding to 4500 ADRs were analysed. On average, 234 ADR reports were submitted annually, corresponding to approximately two ADRs per report. From 2003 to 2005, an increasing number of ADRs submitted per report were observed, but after 2005 the reporting rate decreased. One-half of ADRs were reported for infants from birth to 2 years of age. Similar total numbers of ADRs were reported for boys and girls. The majority of ADRs reported were from the following SOCs: general disorders and administration site conditions (31%), skin and subcutaneous tissue disorders (18%) and nervous system disorders (15%). Reports encompassed medicines from ATC group J: vaccines and anti-infectives for systemic use (65%); and ATC group N: nervous system (17%). On average, 42% of ADRs were classified as serious. ATC group N had the highest proportion of ADRs that were classified as serious. Although physicians reported approximately 90% of the ADRs, a relatively large proportion of serious ADRs were reported by other sources. In Denmark, the ADR reporting rate in the paediatric population has declined since 2005. The majority of ADRs reported in young children were reported for vaccines and anti-infectives, but also a high number of serious ADRs were reported for medicines from ATC group N. The Danish Medicines Agency should monitor prescribing patterns more tightly to identify potential risks in the paediatric population in relation to the evolving pattern of medicine use among children.
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                Author and article information

                Journal
                BMC Res Notes
                BMC Research Notes
                BioMed Central
                1756-0500
                2010
                23 June 2010
                : 3
                : 176
                Affiliations
                [1 ]Department of Pharmacology and Pharmacotherapy, Section for Social Pharmacy, Faculty of Pharmaceutical Sciences, University of Copenhagen, Denmark
                [2 ]FKL Research Centre for Quality in Medicine Use, Universitetsparken 2, DK- 2100 Copenhagen, Denmark
                Article
                1756-0500-3-176
                10.1186/1756-0500-3-176
                2901212
                20573185
                52b805dc-1cb8-441e-97a2-b6597faa4dab
                Copyright ©2010 Aagaard et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 18 March 2010
                : 23 June 2010
                Categories
                Short Report

                Medicine
                Medicine

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