ABSTRACT. Objective. To characterize risks to infants and young children from drugs and biological products that were identified in spontaneous adverse event reports submitted to the US Food and Drug Administration.Methods. Of >500 000 MedWatch adverse event reports received by the Food and Drug Administration from November 1997 through December 2000, we identified 7111 reports about infants and children younger than age 2. The reports were analyzed for health outcome (eg, death, hospitalization, congenital anomaly), principal suspect drug, and whether the route of drug exposure was direct administration or through the mother in the perinatal period.Results. Drug therapy was associated with an average of 243 reported deaths annually over the 38-month study period, with 100 (41%) occurring during the first month of life and 204 (84%) during the first year. In 1432 (24%) reported adverse event cases of all levels of severity, exposure to the drug was from the mother during pregnancy, delivery, or lactation. Although 1902 different drugs, biological products, and other chemicals were identified in the reports, only 17 drugs or biological products were a suspect in 54% of all serious and fatal adverse events in drugs administered directly.Conclusion. Adverse reactions to drug therapy are a significant cause of death and injury in infants and children under 2 years of age. Drugs administered to the mother in the perinatal period constituted a major route of exposure to adverse drug advents. These results underscore the need for additional drug testing in the youngest pediatric patients and for carefully weighing the risks versus benefits of medication. Pediatrics 2002; 110(5). URL: http://www.pediatrics.org/cgi/content/full/ 110/5/e53; infant, child, adverse drug reaction reporting systems, drug therapy.

Antidepressant use changed post-PPHA and -FDACM, with a differential pattern by age. There was no evidence of increased antipsychotic use post-FDACM. Ecologic data cannot determine if changes were due to depression not treated with medications or the prescribing of fewer antidepressants for other conditions.

Objective To describe the prevalence, trends, and patterns in use of antidiabetic medications to treat hyperglycemia and insulin resistance prior to and during pregnancy in a large U.S. cohort of insured pregnant women. Methods Pregnancies resulting in livebirths were identified (N=437,950) from 2001–2007 among 372,543 women 12–50 years of age at delivery from 10 health maintenance organizations participating in the Medication Exposure in Pregnancy Risk Evaluation Program. Information for these descriptive analyses, including all antidiabetic medications dispensed during this period, was extracted from electronic health records and infant birth certificates. Results Just over one percent (1.21%) of deliveries were to women dispensed antidiabetic medication(s) in the 120 days before pregnancy. Use of antidiabetic medications before pregnancy increased from 0.66% of deliveries in 2001 to 1.66% of deliveries in 2007 (p<0.001) due to a rise in metformin use. Most women using metformin before pregnancy had a diagnosis code for polycystic ovaries or female infertility (67.2%) while only 13.6% had a diagnosis code for diabetes. The use of antidiabetic medications during the second or third trimester of pregnancy increased from 2.8% of deliveries in 2001 to 3.6% in 2007 (p <0.001). Approximately two-thirds (68%) of women using metformin before pregnancy did not use any antidiabetic medications during pregnancy. Conclusions Antidiabetic medication use prior to and during pregnancy rose from 2001–2007, possibly due to increasing prevalence of gestational diabetes mellitus, type 1 and type 2 diabetes, and other conditions associated with insulin resistance.

Background Asthma is one of the most common chronic diseases in women of reproductive age, occurring in up to 8% of pregnancies. Objective Assess the prevalence of asthma medication use during pregnancy in a large diverse cohort. Methods We identified women aged 15 to 45 years who delivered a live born infant between 2001 and 2007 across 11 U.S. health plans within the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP). Using health plans’ administrative and claims data, and birth certificate data, we identified deliveries for which women filled asthma medications from 90 days before pregnancy through delivery. Prevalence (%) was calculated for asthma diagnosis and medication dispensing. Results There were 586,276 infants from 575,632 eligible deliveries in the MEPREP cohort. Asthma prevalence among mothers was 6.7%, increasing from 5.5% in 2001 to 7.8% in 2007. A total of 9.7% (n=55,914) of women were dispensed asthma medications during pregnancy. The overall prevalence of maintenance-only medication, rescue-only medication, and combined maintenance and rescue medication was 0.6%, 6.7%, and 2.4% respectively. The prevalence of maintenance-only use doubled during the study period from 0.4% to 0.8%, while rescue-only use decreased from 7.4% to 5.8%. Conclusions In this large population-based pregnancy cohort, the prevalence of asthma diagnoses increased over time. The dispensing of maintenance-only medication increased over time, while rescue-only medication dispensing decreased over time.

Small increases in antidepressant medication dispensing rates occurred after initiating montelukast. However, similar increases were observed in the fluticasone and LABA/ICS comparison groups. The results of this study cannot support a specific association between initiation of montelukast treatment and an increase in psychiatric adverse effects.