The role of pharmacoepidemiology in pharmacovigilance: rational drug use in pregnancy

Effect of maternal asthma, exacerbations and asthma medication use on congenital malformations in offspring: a UK population-based study

“…In another case-control study, Tamasi et al 13 only found an increased risk of malformation associated with gestational fenoterol exposure (unadjusted OR 1.6, 95% CI 1.3 to 2.0) but not with cromones or other specific medications, although they did not assess gestational drug exposures with system-specific malformations. Relative methodological differences to our study include asthma drug exposures that were recorded via postal questionnaires to mothers after the birth of the child in the study by Tamasi et al , probable differential ascertainment of information between mothers of cases and controls, inclusion of minor malformations such as club foot and undescended testis, and an earlier study period (1980–96) resulting in less asthma medication use overall and rare use of newer asthma therapies such as long-acting β agonists 13 15 16. In an early 1982 case series, Wilson41 reported that, among 296 women exposed to sodium cromoglicate in pregnancy, only 4 (1.4%) of their offspring had congenital malformations which was lower than the 2–3% expected in the general population.…”

“…More recently, larger studies have been conducted in Hungary13 and Sweden 14. The first13 found that mothers of children with malformations had a 20% greater risk of having asthma compared with mothers of children without malformations; however, asthma drug use was self-reported after a malformation outcome was known and the proportions of drug-exposed women were extremely small 15 16. In Sweden14 a small (9%) but statistically significant increase in congenital malformation was found in children of women reporting use of anti-asthmatic drugs in pregnancy compared with non-users, although no consistent pattern of malformations was identified and the authors concluded that further large studies were needed.…”

Effect of maternal asthma, exacerbations and asthma medication use on congenital malformations in offspring: a UK population-based study

“…In another case-control study, Tamasi et al 13 only found an increased risk of malformation associated with gestational fenoterol exposure (unadjusted OR 1.6, 95% CI 1.3 to 2.0) but not with cromones or other specific medications, although they did not assess gestational drug exposures with system-specific malformations. Relative methodological differences to our study include asthma drug exposures that were recorded via postal questionnaires to mothers after the birth of the child in the study by Tamasi et al , probable differential ascertainment of information between mothers of cases and controls, inclusion of minor malformations such as club foot and undescended testis, and an earlier study period (1980–96) resulting in less asthma medication use overall and rare use of newer asthma therapies such as long-acting β agonists 13 15 16. In an early 1982 case series, Wilson41 reported that, among 296 women exposed to sodium cromoglicate in pregnancy, only 4 (1.4%) of their offspring had congenital malformations which was lower than the 2–3% expected in the general population.…”

“…More recently, larger studies have been conducted in Hungary13 and Sweden 14. The first13 found that mothers of children with malformations had a 20% greater risk of having asthma compared with mothers of children without malformations; however, asthma drug use was self-reported after a malformation outcome was known and the proportions of drug-exposed women were extremely small 15 16. In Sweden14 a small (9%) but statistically significant increase in congenital malformation was found in children of women reporting use of anti-asthmatic drugs in pregnancy compared with non-users, although no consistent pattern of malformations was identified and the authors concluded that further large studies were needed.…”

Dose-dependent Effect of Folic Acid on the Prevention of Orofacial Clefts

“…17 The strength and weakness of the HCCSCA have been discussed previously. 13 However, we note that this is the largest case-control dataset of its type in the world and population-based sampling makes risk-benefit assessment possible. A significant reduction was found in the rate of isolated CL Ϯ CP and CP attributable to the pharmacological doses (in general, 6 mg daily) of folic acid supplementation during pregnancy.…”

Causalidade em farmacoepidemiologia e farmacovigilância: uma incursão teórica

“…The first mention of this science in the scientific literature occurred in the early 1980s. 32 The American academic view encompasses pharmacovigilance and epidemiological studies, that is, it is not restricted to drug safety alone 32 .…”

“…Another limitation concerns the binomial suspension-reintroduction of the drug -considered as a reference standard for the establishment of cause and effect relationships in pharmacovigilance -which is not very effective, for reasons of safety and ethics 27 . In order to bypass its limitations, health regulations in Europe have incorporated different methods that contribute to the surveillance and control of ADE, including epidemiological methods, such as observational studies 32 . Unlike pharmacoepidemiology, pharmacovigilance is exclusively concerned with drug safety.…”

Effect of maternal asthma, exacerbations and asthma medication use on congenital malformations in offspring: a UK population-based study

“…In another case-control study, Tamasi et al 13 only found an increased risk of malformation associated with gestational fenoterol exposure (unadjusted OR 1.6, 95% CI 1.3 to 2.0) but not with cromones or other specific medications, although they did not assess gestational drug exposures with system-specific malformations. Relative methodological differences to our study include asthma drug exposures that were recorded via postal questionnaires to mothers after the birth of the child in the study by Tamasi et al , probable differential ascertainment of information between mothers of cases and controls, inclusion of minor malformations such as club foot and undescended testis, and an earlier study period (1980–96) resulting in less asthma medication use overall and rare use of newer asthma therapies such as long-acting β agonists 13 15 16. In an early 1982 case series, Wilson41 reported that, among 296 women exposed to sodium cromoglicate in pregnancy, only 4 (1.4%) of their offspring had congenital malformations which was lower than the 2–3% expected in the general population.…”

“…More recently, larger studies have been conducted in Hungary13 and Sweden 14. The first13 found that mothers of children with malformations had a 20% greater risk of having asthma compared with mothers of children without malformations; however, asthma drug use was self-reported after a malformation outcome was known and the proportions of drug-exposed women were extremely small 15 16. In Sweden14 a small (9%) but statistically significant increase in congenital malformation was found in children of women reporting use of anti-asthmatic drugs in pregnancy compared with non-users, although no consistent pattern of malformations was identified and the authors concluded that further large studies were needed.…”

Dose-dependent Effect of Folic Acid on the Prevention of Orofacial Clefts

“…17 The strength and weakness of the HCCSCA have been discussed previously. 13 However, we note that this is the largest case-control dataset of its type in the world and population-based sampling makes risk-benefit assessment possible. A significant reduction was found in the rate of isolated CL Ϯ CP and CP attributable to the pharmacological doses (in general, 6 mg daily) of folic acid supplementation during pregnancy.…”

Causalidade em farmacoepidemiologia e farmacovigilância: uma incursão teórica

“…The first mention of this science in the scientific literature occurred in the early 1980s. 32 The American academic view encompasses pharmacovigilance and epidemiological studies, that is, it is not restricted to drug safety alone 32 .…”

“…Another limitation concerns the binomial suspension-reintroduction of the drug -considered as a reference standard for the establishment of cause and effect relationships in pharmacovigilance -which is not very effective, for reasons of safety and ethics 27 . In order to bypass its limitations, health regulations in Europe have incorporated different methods that contribute to the surveillance and control of ADE, including epidemiological methods, such as observational studies 32 . Unlike pharmacoepidemiology, pharmacovigilance is exclusively concerned with drug safety.…”

Effect of maternal asthma, exacerbations and asthma medication use on congenital malformations in offspring: a UK population-based study

“…In another case-control study, Tamasi et al 13 only found an increased risk of malformation associated with gestational fenoterol exposure (unadjusted OR 1.6, 95% CI 1.3 to 2.0) but not with cromones or other specific medications, although they did not assess gestational drug exposures with system-specific malformations. Relative methodological differences to our study include asthma drug exposures that were recorded via postal questionnaires to mothers after the birth of the child in the study by Tamasi et al , probable differential ascertainment of information between mothers of cases and controls, inclusion of minor malformations such as club foot and undescended testis, and an earlier study period (1980–96) resulting in less asthma medication use overall and rare use of newer asthma therapies such as long-acting β agonists 13 15 16. In an early 1982 case series, Wilson41 reported that, among 296 women exposed to sodium cromoglicate in pregnancy, only 4 (1.4%) of their offspring had congenital malformations which was lower than the 2–3% expected in the general population.…”

“…More recently, larger studies have been conducted in Hungary13 and Sweden 14. The first13 found that mothers of children with malformations had a 20% greater risk of having asthma compared with mothers of children without malformations; however, asthma drug use was self-reported after a malformation outcome was known and the proportions of drug-exposed women were extremely small 15 16. In Sweden14 a small (9%) but statistically significant increase in congenital malformation was found in children of women reporting use of anti-asthmatic drugs in pregnancy compared with non-users, although no consistent pattern of malformations was identified and the authors concluded that further large studies were needed.…”

Dose-dependent Effect of Folic Acid on the Prevention of Orofacial Clefts

“…17 The strength and weakness of the HCCSCA have been discussed previously. 13 However, we note that this is the largest case-control dataset of its type in the world and population-based sampling makes risk-benefit assessment possible. A significant reduction was found in the rate of isolated CL Ϯ CP and CP attributable to the pharmacological doses (in general, 6 mg daily) of folic acid supplementation during pregnancy.…”

Causalidade em farmacoepidemiologia e farmacovigilância: uma incursão teórica

“…The first mention of this science in the scientific literature occurred in the early 1980s. 32 The American academic view encompasses pharmacovigilance and epidemiological studies, that is, it is not restricted to drug safety alone 32 .…”

“…Another limitation concerns the binomial suspension-reintroduction of the drug -considered as a reference standard for the establishment of cause and effect relationships in pharmacovigilance -which is not very effective, for reasons of safety and ethics 27 . In order to bypass its limitations, health regulations in Europe have incorporated different methods that contribute to the surveillance and control of ADE, including epidemiological methods, such as observational studies 32 . Unlike pharmacoepidemiology, pharmacovigilance is exclusively concerned with drug safety.…”