scholarly journals Safety of Delafloxacin: Focus on Adverse Events of Special Interest

2018 ◽  
Vol 5 (10) ◽  
Author(s):  
Thomas Lodise ◽  
Ralph Corey ◽  
David Hooper ◽  
Sue Cammarata
Keyword(s):  
United States ◽  
Adverse Events ◽  
Special Interest ◽  
Clinical Studies ◽  
The United States ◽  
Phase Iii ◽  
Serious Adverse Events ◽  
Resistant Strains ◽  
Primary Focus ◽  
Additional Support

Abstract Background Fluoroquinolones have been widely used for a variety of Gram-positive and Gram-negative infections, and by 2002 they had become the most commonly prescribed class of antibiotics for adults in the United States. With widespread use, the class has become associated with a range of adverse events. Delafloxacin is a fluoroquinolone approved in the United States for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs). Delafloxacin is differentiated from other fluoroquinolones due to structural differences and in its activity against methicillin-resistant Staphylococcus aureus, including quinolone-resistant strains. This paper reviews the safety profile of delafloxacin across clinical studies with an emphasis on the incidence of adverse events of special interest that are associated with fluoroquinolones. Methods Data from 2 completed phase III studies of delafloxacin for the treatment of ABSSSIs were pooled and are the primary focus of this paper. Additional support from the full safety analysis set (30 completed phase I to phase III clinical studies) is included where applicable. Results Fewer patients in the pooled delafloxacin group had AESIs than in the comparator group (7.0% vs 9.2%, respectively). Delafloxacin had a low rate of discontinuations due to treatment-related adverse events (<1%). Serious adverse events occurred at similar rates in patients treated with delafloxacin vs comparators. Conclusions Serious adverse events occurred at similar rates in patients treated with delafloxacin vs nonquinolone comparators used to treat ABSSSIs. Clinicaltrials.gov identifier NCT01984684 and NCT01811732

Serious Adverse Events Reported with Dietary Supplement Use in the United States: A 2.5 Year Experience

2018 ◽  
Vol 17 (2) ◽  
pp. 227-248 ◽  
Author(s):  
Stephen M. Schmitz ◽  
Hector L. Lopez ◽  
Douglas Mackay ◽  
Haiuyen Nguyen ◽  
Paula E. Miller
Keyword(s):  
United States ◽  
Adverse Events ◽  
Dietary Supplement ◽  
The United States ◽  
Serious Adverse Events ◽  
Supplement Use ◽  
Dietary Supplement Use

Retrospective Analysis of the Medication Utilization and Clinical Outcomes of Patients Treated with Various Regimens for Hepatitis C Infection

2016 ◽  
Vol 30 (2) ◽  
pp. 154-161 ◽  
Author(s):  
William D. Trombatt ◽  
Pamela H. Koerner ◽  
Zoie N. Craft ◽  
Richard T. Miller ◽  
Khalid M. Kamal
Keyword(s):  
United States ◽  
Hepatitis C ◽  
Adverse Events ◽  
Clinical Outcomes ◽  
The United States ◽  
Virologic Response ◽  
Phase Iii ◽  
Hepatitis C Infection ◽  
Medication Utilization ◽  
Patient Reported

Background: The hepatitis C virus (HCV) is the most common chronic blood-borne infection and the leading cause of liver transplantation in the United States. There are approximately 3.2 million people currently infected with HCV in the United States. In late 2013, the introduction of sofosbuvir and simeprevir represented a critical advancement in the treatment of HCV by improving sustained virologic response (SVR) rates. Purpose: The purpose of this study was to evaluate medication utilization and clinical outcomes of patients with HCV who were treated with any Food and Drug Administration-approved combination of ribavirin, peginterferon products, simeprevir, and sofosbuvir. Methods: Prescription records and clinical assessment forms of patients who started HCV therapy and were eligible for SVR between January 1, 2014, and December 31, 2014, were retrospectively reviewed. Data collection included patient demographics, genotype, SVR, patient-reported adverse events, discontinuations, and adherence markers. Results: A total of 367 eligible patients were identified who had initiated treatment during the study period. Genotype 1 was the most common genotype, and an overall SVR rate of 86.9% was observed. Results were similar to those seen in phase III clinical trials. In addition, adverse events of these medications were more tolerable, and discontinuation rates were lower than with previous therapies.

scholarly journals The rate of smallpox vaccine-associated adverse events in the United States, and smallpox preparedness activities by the Netherlands, Germany, and WHO

2003 ◽  
Vol 7 (9) ◽  
Author(s):  
Keyword(s):  
United States ◽  
Adverse Events ◽  
Signs And Symptoms ◽  
The United States ◽  
Smallpox Vaccine ◽  
Smallpox Vaccination ◽  
Serious Adverse Events ◽  
Control And Prevention ◽  
Life Threatening ◽  
Ongoing Surveillance

The Centers for Disease Control and Prevention (CDC) and state health departments in the United States are conducting ongoing surveillance for adverse effects due to smallpox vaccine during the civilian smallpox vaccination programme (1). Out of 4213 civilian healthcare workers vaccinated between 24 January and 14 February 2003, no potentially life threatening or moderate to severe adverse events have been reported. Seven vaccine recipients were reported to have non-serious adverse events. The most common signs and symptoms were fever (n=two), rash (n=two), malaise (n=two), pruritis (n=two), hypertension (n=two), and pharyngitis (n=two) (Table).

Incisional Hernia in the United States: Trends in Hospital Encounters and Corresponding Healthcare Charges

2018 ◽  
Vol 84 (1) ◽  
pp. 118-125 ◽  
Author(s):  
Valeriy Shubinets ◽  
Justin P. Fox ◽  
Michael A. Lanni ◽  
Michael G. Tecce ◽  
Eric M. Pauli ◽  
...  
Keyword(s):  
United States ◽  
Adverse Events ◽  
Incisional Hernia ◽  
Private Insurance ◽  
The United States ◽  
Hospital Charges ◽  
Hospital Discharges ◽  
Serious Adverse Events ◽  
Comorbidity Index ◽  
Primary Payer

Incisional hernia (IH) is a challenging, potentially morbid condition. This study evaluates recent trends in hospital encounters associated with IH care in the United States. Using Nationwide Inpatient Sample databases from 2007 to 2011, annual estimates of IH-related hospital discharges, charges, and serious adverse events were identified. Significance in observed trends was tested using regression modeling. From 2007 to 2011, there were 583,054 hospital discharges associated with a diagnosis of IH. 81.1 per cent had a concurrent procedure for IH repair. The average discharge included a female patient (63.2%), 59.8 years of age, with either Medicare (45.3%) or Private insurance (38.3%) as the anticipated primary payer. Comparing 2007 to 2011, significant increases in IH discharges (12%; 2007 = 109,702 vs 2011 = 123,034, P = 0.009) and IH repairs (10%; 2007 = 90,588 vs 2011 = 99,622, P < 0.001) were observed. This was accompanied by a 37 per cent increase in hospital charges (2007 = $44,587 vs 2011 = $60,968, P < 0.001), resulting in a total healthcare bill of $7.3 billion in 2011. Significant trends toward greater patient age (2007 = 59.7 years vs 2011 = 60.2 years, P < 0.001), higher comorbidity index (2007 = 3.0 vs 2011 = 3.5, P < 0.001), and increased frequency of serious adverse events (2007 = 13.5% vs 2011 = 17.7%, P < 0.001) were noted. Further work is needed to identify interventions to mitigate the risk of IH development.

OBSERVE-5: Comparison of Etanercept-Treated Psoriasis Patients From Canada and the United States

2018 ◽  
Vol 22 (3) ◽  
pp. 297-303
Author(s):  
Kim A. Papp ◽  
Marc Bourcier ◽  
Yves Poulin ◽  
Charles W. Lynde ◽  
Martin Gilbert ◽  
...  
Keyword(s):  
United States ◽  
Adverse Events ◽  
Maintenance Dose ◽  
Management Strategies ◽  
The United States ◽  
Incidence Rates ◽  
Serious Adverse Events ◽  
End Points ◽  
Safety Outcome ◽  
Medical Interest

Background: OBSERVE-5 surveillance registry results evaluating etanercept safety and effectiveness in patients with moderate to severe psoriasis from Canada and the United States have been reported from data collected between May 2006 and December 2012. Although both countries have an identical indicated starting dose, the maintenance dose can differ and thus affect management strategies and outcomes. Objective: To compare the long-term safety and effectiveness outcomes of etanercept in the Canadian and US cohorts. Methods: Primary end points included exposure-adjusted event incidence rates of serious adverse events and serious infectious events. Secondary end points included exposure-adjusted event incidence rates of events of medical interest and efficacy outcomes. Results: Over 5 years, Canadian patients received a higher maintenance dose of etanercept (50 mg twice/week) more frequently than those from the United States. Safety outcome comparisons revealed that Canadian patients had a significantly lower occurrence of serious adverse events than patients from the United States, with an overall exposure-adjusted event incidence rate per 100 patient-years of 4.46 (95% confidence interval [CI], 3.05-6.29) vs 7.76 (95% CI 7.04-8.54), respectively. Serious infectious event rates were not significantly different between the 2 countries. Secondary outcomes of events of medical interest and effectiveness also did not reveal significant differences between the 2 cohorts. Conclusion: After 5 years of etanercept use, safety and effectiveness outcomes were similar between patients from Canada and the United States, with the exception of a significantly lower rate of serious adverse events in the Canadian population.

Safety and Clinical Outcomes of an Equine-derived Heptavalent Botulinum Antitoxin Treatment for Confirmed or Suspected Botulism in the United States

2019 ◽  
Vol 70 (9) ◽  
pp. 1950-1957 ◽  
Author(s):  
Jason S Richardson ◽  
Geraldine S Parrera ◽  
Hugo Astacio ◽  
Harpreet Sahota ◽  
Deborah M Anderson ◽  
...  
Keyword(s):  
United States ◽  
Mechanical Ventilation ◽  
Adverse Events ◽  
Clinical Outcomes ◽  
Kidney Injury ◽  
Final Diagnosis ◽  
The United States ◽  
Serious Adverse Events ◽  
Underlying Illness ◽  
Life Threatening

Abstract Background Botulism is a rare, life-threatening paralytic illness. Botulism Antitoxin Heptavalent (A,B,C,D,E,F,G)-(Equine) (BAT) manufactured by Emergent BioSolutions Canada Inc is an equine-derived heptavalent botulinum antitoxin product indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A-G in adults and pediatric patients. BAT product was US-licensed in 2013. Methods In the United States, from October 2014 through July 2017, safety and clinical outcomes data were collected under a registry for patients treated with BAT product. Results Registry patients had a median age of 51 years (range, 32 days to 92 years). Among 162 patients, 7 (4.3%) experienced BAT product–related serious adverse events, including 1 (0.6%) report each of pneumonia, pneumonia aspiration, ventricular tachycardia, upper gastrointestinal hemorrhage, anaphylactic reaction, acute kidney injury, and acute myocardial infarction. Thirty-one (19.1%) patients had 41 BAT product–related adverse events. Six (3.7%) deaths were reported in the registry. All deaths were attributed to the underlying illness and were assessed as unlikely related to BAT product. Among 113 (69.8%) patients with a final diagnosis of botulism, those treated early (≤2 days) spent fewer days in the hospital (5 vs 15.5 days), in the intensive care unit (ICU) (4 vs 12 days), and on mechanical ventilation (6 vs 14.5 days) than those treated late (&gt;2 days), respectively. Conclusions BAT product was well tolerated in patients. Treatment with BAT product at ≤2 days of symptom onset was associated with shorter hospital and ICU stays, and shorter duration and need for mechanical ventilation, showing clinical benefit associated with early treatment.

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