ABSTRACT
AIMS: The aim of this study was to monitor the trajectories of antidepressant use during pregnancy and the postpartum period among women chronically treated with antidepressants before their pregnancy, and to assess characteristics associated with each trajectory. METHODS: This cohort study included all pregnant women whose data were included in the General Sample of Beneficiaries (EGB) database affiliated with the French Health Insurance System, from 2009 to 2014. Women were followed up until 6 months after childbirth. Chronic treatment was defined as exposure over the 6-month period preceding pregnancy. A group-based trajectory model (GBMT) was estimated to identify distinctive longitudinal profiles of antidepressant use. RESULTS: Among 760 women chronically treated with antidepressants before their pregnancy, 55.8% stopped their treatment permanently in the first trimester, 20.4% discontinued it for a minimum of 3 months and resumed it postpartum, and 23.8% maintained it throughout pregnancy and postpartum. No sociodemographic or medical characteristics were associated with any trajectory group. Women who maintained treatment presented more frequent obstetric complications and postpartum psychiatric disorders. Among women who interrupted treatment, prescription of benzodiazepines and anxiolytics decreased initially but rose postpartum to a higher level than before pregnancy. CONCLUSIONS: Pregnant women treated with antidepressant require a re-evaluation of psychiatric treatment. It is necessary to pay attention to obstetric complications for severely depressed women. Additionally, as relapse was associated with increased benzodiazepine use, it is important to carefully monitor all women who stop antidepressant treatment during pregnancy.
Subject(s)
Antidepressive Agents , Pregnancy Complications , Antidepressive Agents/adverse effects , Benzodiazepines , Cohort Studies , Female , Humans , Postpartum Period , Pregnancy , Pregnancy Complications/drug therapy , Pregnancy Complications/epidemiologyABSTRACT
BACKGROUND: Several clusters of encephalopathy occurred after the market change from Holoxan® (ifosfamide lyophilized powder) to Ifosfamide EG® (liquid formulation) and justified a formal survey in 2015. In June 2016, the regulatory authority decided to apply a precautionary measure in reducing the shelf life of Ifosfamide EG® at 7 months. One-year study from spontaneous reports lead to suspect a potential residual risk. Due to the many limitations associated with spontaneous notifications, we performed a multicentric observational study, aiming to better explore this pharmacovigilance signal. METHODS: We performed a case-control study in pediatric oncology Departments of 25 university hospitals between July 1st, 2016 and July 1st, 2018. All children (<18 y.o.) receiving liquid formulation or lyophilized powder formulation during the study period were included. Patients with at least one occurrence of encephalopathy were considered as cases. Logistic regression model was used to estimate the odds ratio of encephalopathy between exposure groups. RESULTS: During the study period, 52 cases and 495 controls were included. A residual over-risk of encephalopathy was associated with ifosfamide 7-month shelf-life liquid formulation compared to lyophilized powder (adjusted OR 1.91, 95% CI: 1.03-3.53). CONCLUSIONS: Observed difference does not seem to be related to the pathology treated, the doses used, the co-medications, a meningeal localization and/or an irradiation of the central nervous system. This study confirms data from spontaneous reports that led to the precautionary measure for the liquid formulation. Even if the risk of encephalopathy seems reduced, our study suggests the persistence of a residual risk of encephalopathy associated with liquid formulation compared to the lyophilized powder.
Subject(s)
Brain Diseases , Ifosfamide , Antineoplastic Agents, Alkylating/adverse effects , Brain Diseases/chemically induced , Brain Diseases/drug therapy , Brain Diseases/epidemiology , Case-Control Studies , Child , Humans , Ifosfamide/adverse effects , Retrospective Studies , Risk FactorsSubject(s)
Afibrinogenemia/chemically induced , Afibrinogenemia/epidemiology , Antibodies, Monoclonal, Humanized/adverse effects , Adult , Age Distribution , Aged , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/therapeutic use , Dose-Response Relationship, Drug , Drug Administration Schedule , Female , Fibrinogen/analysis , Follow-Up Studies , Humans , Incidence , Infusions, Intravenous , Middle Aged , Risk Assessment , Sampling StudiesABSTRACT
BACKGROUND: Intravenous Panpharma heparin(®) was used in all on-pump cardiac surgery in our heart-surgery department for a short period. This brand of heparin replaced the previous Choay heparin(®) heparin supplied by the Sanofi-Aventis Laboratory. Unusual postoperative bleedings over this period prompted us to evaluate postoperative hemostasis by comparing these two heparins. METHODS: We compared data from patients who had undergone on-pump cardiac surgery during Panpharma heparin(®) period (group P, 257 patients) to those how received Choay heparin(®) (group C, 194 patients). RESULTS: Despite group P receiving a significantly lower dose of heparin (mean dose 21,000 IU/CEC) compared to group C (mean dose 22,000 IU/CEC) (p = 0.05), the number of surgical re-explorations needed to perfect postoperative hemostasis was significantly higher for group P (3.5% vs. 0) (p = 0.01). Heparin anti-Xa activity after surgery was higher in group P at postoperative h1 and h12 compared to group C, which explained reoperations for hemostasis. CONCLUSION: Despite standardization, variations remain regarding anticoagulant activity between different manufacturing processes and heparin preparations. Surgical teams need to be aware that the biological effects of different brands of heparin may not be as expected and could endanger a usually safe procedure, such as cardiac surgery.
