scholarly journals Does Low-dose Droperidol Administration Increase the Risk of Drug-induced QT Prolongation and Torsade de Pointes in the General Surgical Population?

2007 ◽  
Vol 107 (4) ◽  
pp. 531-536 ◽  
Author(s):  
Gregory A. Nuttall ◽  
Karen M. Eckerman ◽  
Kelly A. Jacob ◽  
Erin M. Pawlaski ◽  
Susan K. Wigersma ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Drug Administration ◽  
Low Dose ◽  
Food And Drug Administration ◽  
Torsade De Pointes ◽  
Black Box ◽  
Qt Prolongation ◽  
Time Interval ◽  
Drug Induced ◽  
Time Period

Background The US Food and Drug Administration issued a black box warning regarding the use of droperidol and the potential for torsade de pointes (TdP). Methods The primary objective of this retrospective study was to determine whether low-dose droperidol administration increased the incidence of TdP in the general surgical population during a 3-yr time period before and after the Food and Drug Administration black box warning. A random sample of 150 surgical patients during each time interval was selected to estimate the droperidol use for each time period. Results During the time period before the black box warning (July 1, 1998 to June 30, 2001), 2,321/139,932 patients (1.66%) had QT prolongation, TdP, or death within 48 h after surgery. We could identify no patients who clearly developed TdP before the black box warning. There was one patient for whom the cause of death could not positively be ruled out as due to TdP. In the time period after the black box warning (July 1, 2002 to June 30, 2005), 2,207 patients (1.46%) had documented QT prolongation, TdP, or death within 48 h after surgery, including only two cases (<0.1%) of TdP. The incidence of droperidol exposure was approximately 12% (exact 95% confidence interval, 7.3-18.3%) before the black box warning and 0% after placement of the black box warning on droperidol. Therefore, we estimate that approximately 16,791 patients (95% confidence interval, 10,173-25,607) were exposed to droperidol, none of whom experienced documented TdP. Conclusions This indicates that the Food and Drug Administration black box warning for low dose droperidol is excessive and unnecessary.

scholarly journals A Black Box Warning: The Marginalization of White-Collar Crime Victimization

2019 ◽  
Vol 1 (1) ◽  
pp. 24-33 ◽  
Author(s):  
Mary Dodge
Keyword(s):  
Drug Administration ◽  
White Collar Crime ◽  
Wide Spectrum ◽  
Food And Drug Administration ◽  
White Collar ◽  
Black Box ◽  
Additional Research ◽  
Crime Victimization ◽  
Street Level ◽  
Victimization Research

The study of white-collar crime has become a subfield of criminology receiving great attention, though victimization calls for additional research. The black box warning, used by the Food and Drug Administration to denote potential serious hazards of a drug or device, is an apt metaphor for the neglect often associated with the identification, depth, consequences, and, at times, violent nature of white-collar crime victimization. Research on victims is evolving, though compared to street-level crime remains marginalized, despite the serious harms caused by the former. This article offers a review of what researchers have accomplished and identifies topics of concern. White-collar crime targets a wide spectrum of the population and a high number of people, but the black box of victimization demonstrates the need for research that further enhances knowledge and informs policy.

scholarly journals Renewed methane increase for five years (2007–2011) observed by solar FTIR spectrometry

2012 ◽  
Vol 12 (11) ◽  
pp. 4885-4891 ◽  
Author(s):  
R. Sussmann ◽  
F. Forster ◽  
M. Rettinger ◽  
P. Bousquet
Keyword(s):  
Time Series ◽  
Confidence Interval ◽  
Global Scale ◽  
Future Trend ◽  
Time Interval ◽  
Positive Trend ◽  
Time Period ◽  
New Period ◽  
Natural Wetlands ◽  
Surface Network

Abstract. Trends of column-averaged methane for the time period (1996, Sep 2011) are derived from the mid-infrared (mid-IR) solar FTIR time series at the Zugspitze (47.42° N, 10.98° E, 2964 m a.s.l.) and Garmisch (47.48° N, 11.06° E, 743 m a.s.l.). Trend analysis comprises a fit to the de-seasonalized time series along with bootstrap resampling for quantifying trend uncertainties. We find a positive trend during [1996, 1998] of 9.0 [3.2, 14.7] ppb yr−1 for Zugspitze (95% confidence interval), an insignificant growth during [1999, mid 2006] of 0.8 [−0.1, 1.7] ppb yr−1 (Zugspitze), and a significant renewed increase during [mid 2006, Sep 2011] of 5.1 [4.2, 6.0] ppb yr−1 for Garmisch, which is in agreement with 4.8 [3.8, 5.9] ppb yr−1 for Zugspitze. The agreement of methane trends at the two closely neighboring FTIR sites Zugspitze and Garmisch within the uncertainties indicates a good station-to-station consistency as a basis for future trend analyses by the ground-based mid-IR FTIR network on the global scale. Furthermore, the Zugspitze FTIR trend for the time interval [Jul 2006, Jun 2009] is found to agree with the trend derived from SCIAMACHY (WFM-DOAS v2.0.2) data within the 95% confidence intervals. In case a 1000-km pixel selection radius around the Zugspitze is used, the confidence interval is narrower for the FTIR trend (6.9 [4.2, 9.5] ppb yr−1) compared to SCIAMACHY (7.1 [5.1, 8.6] ppb yr−1). If, however, a loosened pixel selection is used (≈1000-km half-width latitudinal band), the SCIAMACHY trend significance interval is narrower (6.8 [5.1, 8.6] ppb yr−1) compared to Zugspitze FTIR (5.7 [3.0, 8.3] ppb yr−1). While earlier studies using surface network data revealed changes of 8.0 ± 0.6 ppb in 2007, 6.4 ± 0.6 ppb in 2008, and 4.7 ± 0.6 ppb in 2009 (Dlugokencky et al., 2011), our updated result proves that the renewed methane increase meanwhile has been persisting for >5 years [mid 2006, Sep 2011]. This is either the longest and largest positive trend anomaly since the beginning of systematic observations more than 25 years ago or the onset of a new period of strongly increasing CH4 levels in the atmosphere. Several scenarios have been developed to explain the persistent increase observed, mainly invoking an increase in emissions from natural wetlands, an increase in fossil fuel-related emissions or a decrease in OH concentrations. However, more work is needed to fully attribute this increase to a particular source or sink.

Brodalumab for Treatment-Resistant Psoriasis: Case Reports and Safety Update

2020 ◽  
Vol 5 (3) ◽  
pp. 82-85
Author(s):  
Nicholas D. Brownstone ◽  
Vidhatha Reddy ◽  
Quinn Thibodeaux ◽  
Stephanie Chan ◽  
Bridget Myers ◽  
...  
Keyword(s):  
Causal Relationship ◽  
Drug Administration ◽  
Safety Profile ◽  
Case Reports ◽  
Food And Drug Administration ◽  
Black Box ◽  
Interleukin 17 ◽  
Treatment Resistant ◽  
Effective Agent ◽  
Increased Risk

Introduction: Brodalumab is an interleukin-17 receptor blocker that is effective for the treatment of psoriasis. However, due to a Food and Drug Administration black box warning on depression and suicide, many providers are hesitant to use this agent despite its efficacy. Methods: We present the cases of 2 brothers seen at our clinic with treatment-resistant psoriasis who were both successfully treated with brodalumab, despite failing 6 other biologics. We also review the safety profile of brodalumab regarding the currently available evidence on the increased risk of suicidality or depression in patients treated with brodalumab. Results: Both patients achieved completely clear skin and maintained clearance on brodalumab. Discussion: Brodalumab appears to be an effective agent in severe treatment-resistant cases of psoriasis. In addition, a causal relationship between increased risk of suicidality or depression and brodalumab use has not been established.

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