Pharmacoepidemiology and drug safety
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Pharmacoepidemiol Drug Saf · Apr 2009
Meta AnalysisAprotinin and the risk of death and renal dysfunction in patients undergoing cardiac surgery: a meta-analysis of epidemiologic studies.
Observational studies have reported conflicting results regarding aprotinin's risk of renal dysfunction and death. A meta-analysis was conducted to summarize results and explain variation of published epidemiologic studies on risks of renal dysfunction and death associated with aprotinin. ⋯ Despite some studies that reported no association between aprotinin and renal outcomes during cardiac surgery, the totality of epidemiologic evidence indicates an increased risk that cannot be fully explained by need for transfused red blood cells (RBCs). Epidemiologic studies also suggest an increased risk of long-term mortality associated with aprotinin as compared to various comparators used in these studies, although residual confounding cannot be ruled out.
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Pharmacoepidemiol Drug Saf · Mar 2009
Magnitude of QT prolongation associated with a higher risk of Torsades de Pointes.
Drug induced Torsades de Pointes (TdP) is a major concern for new drugs seeking regulatory approval. Prolongation of QT intervals greater than 60 millisecond or to longer than 500 millisecond in an individual patient has been considered to be associated with a higher risk. The purpose of this study is to identify values inferred from a population that predict a stronger potential for TdP. ⋯ Drugs strongly associated with TdP have greater QTc increases than those with less concern. Several cut-off values have been noted to distinguish between them. These values may be helpful for evaluation of TdP risk for future QT prolonging drugs.
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Pharmacoepidemiol Drug Saf · Mar 2009
Antidepressant medication use and risk of persistent pulmonary hypertension of the newborn.
To determine the prevalence of persistent pulmonary hypertension of the newborn (PPHN) among infants whose mothers were exposed to antidepressants in the third trimester of pregnancy compared to the prevalence among infants whose mothers were not exposed to antidepressants in the third trimester. ⋯ We did not find an association between SSRI use in late pregnancy and PPHN. Limitations of the present study, including the small number of confirmed cases, suggest further research in this area may be warranted.
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Pharmacoepidemiol Drug Saf · Mar 2009
Emergency department visits attributed to selected analgesics, United States, 2004-2005.
To estimate the rate of emergency department (ED) visits attributed to selected analgesic-containing medications. ⋯ Rates of ED visits due to analgesics vary depending on the age of the patient and the product; most do not result in hospitalization. Although the rate of emergency visits is relatively low, because of the wide use of the analgesics, public health impact is considerable.
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Pharmacoepidemiol Drug Saf · Feb 2009
A computerized system for signal detection in spontaneous reporting system of Shanghai China.
We developed a computerized system for signal detection in spontaneous reporting system (SRS) of Shanghai. Data acquisition, data mining could be carried out automatically and the process of data preprocessing and cleaning could be facilitated. This system was expected to detect signals from SRS after drug licensing with minimum patient exposure. ⋯ The results indicate that this computerized system is a flexible one that can help to detect possible drug-ADR signals intelligently in SRS of Shanghai now. It is a promising system for post-marketing surveillance on both chemical medicine and Chinese traditional medicine.