Pharmacoepidemiology and Drug Safety
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Comments on "Agreement between patients' self-report and physicians' prescriptions on nonsteroidal anti-inflammatory drugs and other drugs u...
Validation of an algorithm to estimate gestational age in electronic health plan databases.
We compared (1) the algorithm-derived gestational age versus the "gold-standard" gestational age obtained from the infant birth certificate file and (2) the prenatal exposure status of two antidepressants (fluoxetine and sertraline) and two antibiotics (amoxicillin and azithromycin) as determined by...
Histamine-2 receptor antagonists and risk of lung cancer in diabetic patients - an exploratory analysis.
A total of 1182 incident SCC and 2345 adenocarcinoma cases were identified, and 13,108 matched controls were selected. An increased risk was observed for H2RBs use <1 year with adjusted OR of 1.33 (95% confidence interval (CI): 1.22-1.44). After excluding all exposures occurring in the year before...
A proposed modification to Hy's law and Edish criteria in oncology clinical trials using aggregated historical data.
These higher liver chemistry thresholds examining fold-ULN and fold-baseline data may be valuable in identifying potential severe liver injury and detecting liver safety signals of clinical concern in oncology clinical trials and postapproval settings while helping to avoid premature discontinuation...
Validation of acute myocardial infarction in the Food and Drug Administration's Mini-Sentinel program.
We identified a random sample of potential cases of AMI in 2009 from four Data Partners participating in the Mini-Sentinel Program. Cardiologist reviewers used information abstracted from hospital records to assess the likelihood of an AMI diagnosis based on criteria from the Joint European Society...
Is spontaneous reporting always the most important information supporting drug withdrawals for pharmacovigilance reasons in France?
The objective of our study was to determine the nature of scientific evidence leading to drug withdrawal for safety reasons in France (between 2005 and 2011). Drugs (i.e., active ingredients) withdrawn were identified from the Web site of the French Health Products Agency. Additional information all...
Prescriptive contraceptive use among isotretinoin users in the Netherlands in comparison with non-users: a drug utilisation study.
To assess the compliance with the isotretinoin Pregnancy Prevention Programme (PPP) by evaluating the use of prescribed contraceptives among isotretinoin users. The PPP contains a requirement for the use of contraceptive methods for women of childbearing potential. A drug utilisation study was perfo...
Post-market drug safety evidence sources: an analysis of FDA drug safety communications.
Use of drug treatments for Alzheimer's disease in France: a study on a national level based on the National Alzheimer's Data Bank (Banque Na...
We analysed a cross-section of the French National Alzheimer's databank (BNA). Participants were individuals who consulted centres contributing to the BNA in 2010 and diagnosed with Alzheimer's disease and with at least one Mini Mental State Examination (MMSE) score recorded during the course of the...
Simulation study of instrumental variable approaches with an application to a study of the antidiabetic effect of bezafibrate.
We studied the application of the generalized structural mean model (GSMM) of instrumental variable (IV) methods in estimating treatment odds ratios (ORs) for binary outcomes in pharmacoepidemiologic studies and evaluated the bias of GSMM compared to other IV methods. Because of the...