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Silver Spring, MD, United States

Sidney S.,Kaiser Permanente | Cheetham T.C.,Kaiser Permanente | Connell F.A.,University of Washington | Ouellet-Hellstrom R.,FDA Office of Surveillance and Epidemiology | And 5 more authors.
Contraception | Year: 2013

Background: Combined hormonal contraceptives (CHCs) place women at increased risk of venous thromboembolic events (VTEs) and arterial thrombotic events (ATEs), including acute myocardial infarction and ischemic stroke. There is concern that three recent CHC preparations [drospirenone-containing pills (DRSPs), the norelgestromin-containing transdermal patch (NGMN) and the etonogestrel vaginal ring (ETON)] may place women at even higher risk of thrombosis than other older low-dose CHCs with a known safety profile. Study Design: All VTEs and all hospitalized ATEs were identified in women, ages 10-55 years, from two integrated health care programs and two state Medicaid programs during the time period covering their new use of DRSP, NGMN, ETON or one of four low-dose estrogen comparator CHCs. The relative risk of thrombotic and thromboembolic outcomes associated with the newer CHCs in relation to the comparators was assessed with Cox proportional hazards regression models adjusting for age, site and year of entry into the study. Results: The hazards ratio for DRSP in relation to low-dose estrogen comparators among new users was 1.77 (95% confidence interval 1.33-2.35) for VTE and 2.01 (1.06-3.81) for ATE. The increased risk of DRSP was limited to the 10-34-year age group for VTE and the 35-55-year group for ATE. Use of the NGMN patch and ETON vaginal ring was not associated with increased risk of either thromboembolic or thrombotic outcomes. Conclusions: In new users, DRSP was associated with higher risk of thrombotic events (VTE and ATE) relative to low-dose estrogen comparator CHCs, while the use of the NGMN patch and ETON vaginal ring was not. © 2013 Elsevier Inc. Source


Pamer C.A.,FDA Office of Surveillance and Epidemiology | Hammad T.A.,FDA Office of Surveillance and Epidemiology | Wu Y.-T.,FDA Office of Biostatistics | Kaplan S.,FDA Office of Surveillance and Epidemiology | And 3 more authors.
Pharmacoepidemiology and Drug Safety | Year: 2010

Purpose: To determine if paroxetine versus non-paroxetine selective serotonin reuptake inhibitors (SSRIs) prescribing changed after the June 2003 FDA Paroxetine Public Health Advisory (PPHA) and if antidepressant and antipsychotic prescribing changed after the February 2004 FDA Advisory Committee Meeting (FDACM). Methods: Ecologic analysis using estimates of patients dispensed antidepressants and antipsychotics, census data, and promotional spending data. Data sources were SDI: Vector One®, US Census, and IMS Health®. Measures were monthly use levels (number of patients dispensed antidepressants, antipsychotics, paroxetine, and non-paroxetine SSRIs prescriptions by age group per population count). Percent changes pre- to post-PPHA were used to assess changes in paroxetine versus non-paroxetine SSRIs prescribing. Interrupted time series (ITS) analysis was performed to examine use level changes post-FDACM by drug groups (all antidepressants and all antipsychotics). Results: Post-PPHA mean paroxetine use levels decreased for all age groups (range: 5.5-34.1%). Mean non-paroxetine SSRIs use levels increased (range: 4.6-17.1%). Post-PPHA changes were greatest for 6-12 and 13-17 year olds. Decreased mean antidepressant drug use levels from pre- to post-FDACM were observed in all groups under 25 years old. A statistically significant decrease in the slopes from pre- to post-FDACM was observed for persons aged 13-17 and 18-24 years. The difference between the forecasted mean use level and the observed mean use level (in 12-month intervals) was statistically significant for all ages combined (-107.26; 95% CI: -166.32, -48.20) and 1-5 (-3.1; 95% CI: -4.62, -1.58), 6-12 (-36.02; 95% CI: -62.92, -9.12) and 25 years, and older groups (-83.17; 95% CI: -153.95, -12.39). For all age groups, decreases in the slopes of antipsychotic drugs use from pre- to post-FDACMwere observed, although these slope changes were not statistically significant. The difference between the forecasted mean antipsychotic drugs use level and the observed mean use level (in 12-month intervals) was statistically significantly lower for all age groups. Conclusions: 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. Source

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