The effect of regulatory advisories on maternal antidepressant prescribing, 1995–2007: an interrupted time series study of 228,876 pregnancies

Abstract

Purpose To assess whether antidepressant prescribing during pregnancy decreased following release of U.S. and Canadian public health advisory warnings about the risk of perinatal complications with antidepressants. Methods We analyzed data from 228,876 singleton pregnancies among women (aged 15–44 years) continuously enrolled in Tennessee Medicaid with full pharmacy benefits (1995–2007). Antidepressant prescribing was determined through outpatient pharmacy dispensing files. Information on sociodemographic and clinical factors was obtained from enrollment files and linked birth certificates. An interrupted time-series design with segmented regression analysis was used to quantify the impact of the advisory warnings (2002–2005). Results Antidepressant prescribing rates increased steadily from 1995–2001, followed by sharper increases from 2002–late 2004. Overall antidepressant prescribing prevalence was 34.51 prescriptions (95% CI 33.37–35.65) per 1,000 women in January 2002, and increased at a rate of 0.46 (95% CI 0.41–0.52) prescriptions per 1,000 women per month until the end of the pre-warning period (May 2004). During the post-warning period (October 2004 – June 2005), antidepressant prescribing decreased by 1.48 (95% CI 1.62-1.35) prescriptions per 1,000 women per month. These trends were observed for both SSRI and non-SSRI antidepressants, although SSRI prescribing decreased at a greater rate. Conclusion Antidepressant prescribing to pregnant women in Tennessee Medicaid increased from 1995–late 2004. U.S. and Canadian public health advisories about antidepressant-associated perinatal complications were associated with steady decreases in antidepressant prescribing from late 2004 until the end of the study period, suggesting that the advisory warnings were impactful on antidepressant prescribing in pregnancy.

Non‐steroidal anti‐inflammatory drug prescriptions from the 6th month of pregnancy: impact of advice from health authorities

“… also highlighted the importance of Health Authority recommendations to remind health professionals of the potential teratogenic or foetotoxic effects of medicines during pregnancy. An American study also noted the positive effect of warnings about the risk of perinatal complications associated with antidepressants during pregnancy .…”

“…In contrast, lamotrigine prescriptions remained unchanged. In 2014, an American study confirmed that antidepressant prescriptions during pregnancy decreased following DDLs issued by the FDA and Health Canada in 2004 about the risk of perinatal complications . The American and Canadian recommendations had a positive effect on antidepressant prescriptions during pregnancy.…”

“…Few studies have been published about the impact of the Health Authorities’ recommendations on drug prescriptions for pregnant women . In France, an initial study by Hurault et al.…”

Ethical and Clinical Dilemmas in Using Psychotropic Medications During Pregnancy

“…In light of an observational study that reported adverse neonatal outcomes associated with maternal antidepressant use [28], the US Food and Drug Administration (FDA) released a public health advisory warning in 2006 about the risk of perinatal complications with antidepressants [29]. Although the warning did not explicitly advise women to avoid or discontinue use of antidepressants during pregnancy, it received widespread media coverage [30] and had a chilling effect on antidepressant use among pregnant women [31]. Follow-up studies called into question the findings that led the FDA to issue the warning [12,24,32,33]; in 2011, the FDA announced that since research findings were conflicting, the warning would be removed from selective serotonin reuptake inhibitor (SSRI) labeling [34].…”

Competent Psychopharmacology

“…The abuse potential of this agent and its overprescription for prison inmates further exemplify prescribing and patient care inadequacies 42,43. From 1995 to 2003, antidepressant use during pregnancy increased 5-fold, only to fall precipitously following regulatory warnings of perinatal complications 44. In contrast, exposure during pregnancy to antpsychotics and their combination with other psychotropics, including potentially teratogenic anticonvulsants, is increasing 45…”