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Reporting Patterns (reporting + pattern)
Selected AbstractsBiases affecting the proportional reporting ratio (PRR) in spontaneous reports pharmacovigilance databases: the example of sertindolePHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 4 2003Nicholas Moore Abstract Background Automated measures of reporting disproportionality in databases of spontaneous reports of adverse drug reactions are an emerging tool to identify drug-related alerts. Sertindole, a new atypical neuroleptic known to prolong the QT interval, was suspended in November 1998 because the proportion of reports of fatal reactions suggesting arrhythmia among all reports with sertindole was almost ten times higher than that for other atypical neuroleptics in the UK. This excess risk was not predicted in preclinical data and had not been found in premarketing trials. Method Reporting patterns over time were analysed. Prescription Event Monitoring (PEM) studies and a large retrospective cohort allowed for the comparison of actual death rates with atypical neuroleptics, and to assess which proportion of the deaths that occurred were reported. Results There were indications of possible skewing of reporting related to notoriety, surveillance and market size effects. Death rates in PEM studies were essentially similar between sertindole and other neuroleptics. Cardiac deaths had been two to three times more often reported than other causes of death. Conclusion Proportional reporting ratios indicate differential reporting of possible reactions, not necessarily differential occurrence. There was no indication of an actual increase of risk of all causes or cardiac deaths during sertindole treatment, but only an increased risk of its being reported. The suspension of sertindole was rescinded by Committee on Proprietary Medicinal Products (CPMP) in October 2001. Copyright © 2003 John Wiley & Sons, Ltd. [source] The utilisation of nuchal translucency as a prenatal marker of Down syndrome, 1993,1999AUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 4 2000Sheila F Mulvey Summary: A sample of 6038 obstetric ultrasound referrals and reports between January 1993 and June 1999 in a single Melbourne private ultrasound practice was reviewed to determine whether the referral and reporting pattern for nuchal translucency (NT) measurement has changed. The proportion of both 10,14 week ultrasound scans and mid trimester fetal anatomy scan referrals increased significantly over the study period (p < 0.001 and p < 0.001, respectively). There was also a significant increase in NT reporting and the number of specific referrals for an NT measurement over the study period (p = 0.01 and p < 0.001, respectively). If current trends continue it is likely that the 10,14 week scan for NT measurement will become a routine component of antenatal care. Therefore, as a matter of urgency, it is imperative that the best and most cost-effective screening strategy for Down syndrome in an Australian population is defined [source] Comparative thrombotic event incidence after infusion of recombinant factor VIIa versus factor VIII inhibitor bypass activityJOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 10 2004L. M. Aledort Summary. Thrombosis is a rare but well-recognized potential complication of Factor VIII Inhibitor Bypass Activity (FEIBA) infusion. Recombinant factor VIIa (rFVIIa) is increasingly used as an alternative to FEIBA; however, the thrombotic safety profile of rFVIIa remains incompletely characterized. To determine the incidence rates of thrombotic adverse events (AEs) after infusion of rFVIIa and FEIBA. Data from the MedWatch pharmacovigilance program of the US Food and Drug Administration, as supplemented by published case reports, were used in conjunction with estimated numbers of infusions available from manufacturers to assess comparative incidence of thrombotic AEs in patients receiving rFVIIa or FEIBA in the period from April 1999 through June 2002. Reported thrombotic AEs were rare, with incidence rates of 24.6 per 105 infusions (CI, 19.1,31.2 per 105 infusions) for rFVIIa and 8.24 per 105 infusions (CI, 4.71,13.4 per 105 infusions) for FEIBA. Thrombotic AEs were significantly more frequent in rFVIIa than FEIBA recipients (incidence rate ratio, 2.98; CI, 1.71,5.52). The most commonly documented single type of thrombotic AE after rFVIIa infusion was cerebrovascular thrombosis, while myocardial infarction was the most frequent type in patients receiving FEIBA. Contrasting AE reporting patterns between rFVIIa and FEIBA may have contributed to the observed difference in thrombotic event incidence. Nevertheless, this comprehensive pharmacovigilance assessment does not support superior thrombotic safety of rFVIIa and suggests that thrombotic AE risk may be higher in rFVIIa than FEIBA recipients. [source] Topical bovine thrombin: a 21-year review of topical bovine thrombin spontaneous case safety reports submitted to FDA's Adverse Event Reporting SystemPHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 2 2010John A. Clark MD Abstract Purpose To review topical bovine thrombin spontaneous adverse event (AE) reports that were forwarded to the US Food and Drug Administration's (FDA) Adverse Event Reporting System (AERS) between January 1986 and December 2006. Methods Forty-one spontaneous AE reports were summarized for reported AE profile and chronological reporting patterns. Each AE report was adjudicated by a hematologist for the topical bovine thrombin product that was given and the AE(s) that were reported. AEs were grouped as allergic, coagulopathy/bleeding, and all other AEs combined. Grouped AE serial analyses were carried out using successive 3-year time increments between 1986 (the year an AE report was first noted for a bovine thrombin product) and 2006 (the first full year that was available at the time of initiation of the data summary). Main outcome measures The primary outcome measures were every 3-year trend lines for all-AE reports, all reporters, and topical bovine thrombin brand mentions for 2 AE groups of interest (allergic events and coagulopathy/bleeding events). Results The all-AE spontaneous reporter trend showed a downward appearance for AE reporting activity that started in 1995,1998 and continued through 2004,2006. The all-AE reports trend showed two potential safety signals that could be identified serially: (1) a prominent 1989,1991 peak that was attributable to allergic events (in particular, anaphylaxis), and (2) a small 1995,2000 broad peak that was attributable in part to coagulopathy/bleeding events. Allergic events were predominantly reported with products approved prior to 1995, were not temporally associated with prior medical literature case reports, and continued to be forwarded to the FDA at low levels up to the end of this study in 2006. Coagulopathy/bleeding events were reported only with products approved prior to 1995, were temporally associated with medical literature case reports, and were not forwarded to the FDA after 2000. Conclusions Overall, spontaneous AE reporting for topical bovine thrombin occurs at very low levels, and appears to have been decreasing since 1995. The serial reporting patterns for topical bovine thrombin are best explained as a strong safety signal for allergic events with ongoing, low level reporting, and a weak safety signal for coagulopathy/bleeding events that ceased on or before 2000. Although this descriptive trend analysis cannot measure associations or causation, the coagulopathy/bleeding signal may have been prompted by multiple, antecedent published case reports. The subsequent diminishment of signal attributed to thrombin likewise may coincide with lack of such reporting in larger follow-up clinical trials or, alternatively, in the introduction and growing market share of thrombin brands of greater purity. Currently marketed topical bovine thrombin formulations are rarely volunteered as possible causes of adverse events. Copyright © 2009 John Wiley & Sons, Ltd. [source] | ||||||||||