scholarly journals Response to Consumer Healthcare Products Association letter to “Trend in rates of acetaminophen-related adverse events in the United States”

2017 ◽  
Vol 26 (3) ◽  
pp. 355-355 ◽  
Author(s):  
Tracy Pham ◽  
Jacqueline M. Major ◽  
Grace Chai ◽  
David Moeny ◽  
Cunlin Wang ◽  
...  
Keyword(s):  
United States ◽  
Adverse Events ◽  
The United States ◽  
Consumer Healthcare

scholarly journals Efficacy and safety of fremanezumab in patients with migraine and inadequate response to prior preventive treatment: subgroup analyses by country of a randomized, placebo-controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Egilius L. H. Spierings ◽  
Mikko Kärppä ◽  
Xiaoping Ning ◽  
Joshua M. Cohen ◽  
Verena Ramirez Campos ◽  
...  
Keyword(s):  
United States ◽  
Czech Republic ◽  
Adverse Events ◽  
Least Squares ◽  
The United States ◽  
Inadequate Response ◽  
Double Blind ◽  
Monthly Average ◽  
Preventive Medication ◽  
Subgroup Analyses

Abstract Background The FOCUS study evaluated the efficacy of migraine preventive medications across different countries within the same patient population, particularly for patients with difficult-to-treat migraine. These prespecified subgroup analyses evaluated efficacy by country in the FOCUS study of fremanezumab in adults with episodic migraine or chronic migraine and documented inadequate response to 2 to 4 migraine preventive medication classes. Methods Overall, 838 participants were enrolled in the FOCUS study, a randomized, double-blind, placebo-controlled, parallel-group, phase 3b study performed at 104 sites. For 12 weeks of double-blind treatment, patients were randomized (1:1:1) to quarterly fremanezumab, monthly fremanezumab, or matched placebo. The primary efficacy endpoint was the mean change from baseline in monthly average migraine days over 12 weeks of double-blind treatment, evaluated by country in these subgroup analyses. Results Of 14 countries contributing data, the Czech Republic (n = 188/838; 22%), the United States (n = 120/838; 14%), and Finland (n = 85/838; 10%) enrolled the most patients. Changes from baseline in monthly average migraine days over 12 weeks were significantly greater with fremanezumab versus placebo for patients in these countries: Czech Republic (least-squares mean difference versus placebo [95% confidence interval]: quarterly fremanezumab, − 1.9 [− 3.25, − 0.47]; P = 0.009; monthly fremanezumab, − 3.0 [− 4.39, − 1.59]; P < 0.001), the United States (quarterly fremanezumab, − 3.7 [− 5.77, − 1.58]; P < 0.001; monthly fremanezumab, − 4.2 [− 6.23, − 2.13]; P < 0.001), and Finland (quarterly fremanezumab, − 3.0 [− 5.32, − 0.63]; P = 0.014; monthly fremanezumab, − 3.9 [− 6.27, − 1.44]; P = 0.002). Results were comparable for the remaining 9 countries, with the least-squares mean difference versus placebo ranging from – 5.6 to – 2.4 with quarterly fremanezumab and from − 5.3 to − 1.5 with monthly fremanezumab. Incidences of serious adverse events and adverse events leading to discontinuation were low and comparable across countries and treatment groups. Conclusions Monthly and quarterly fremanezumab significantly reduced the monthly average number of migraine days versus placebo regardless of country and continent (North America versus Europe) in migraine patients with documented inadequate response to 2 to 4 migraine preventive medication classes. Trial registration ClinicalTrials.gov Identifier: NCT03308968.

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

scholarly journals Association of Gabapentinoids With the Risk of Opioid-Related Adverse Events in Surgical Patients in the United States

2020 ◽  
Vol 3 (12) ◽  
pp. e2031647 ◽  
Author(s):  
Katsiaryna Bykov ◽  
Brian T. Bateman ◽  
Jessica M. Franklin ◽  
Seanna M. Vine ◽  
Elisabetta Patorno
Keyword(s):  
United States ◽  
Adverse Events ◽  
The United States ◽  
Surgical Patients

Prevalence of adverse events in pediatric intensive care units in the United States*

2010 ◽  
Vol 11 (5) ◽  
pp. 568-578 ◽  
Author(s):  
Swati Agarwal ◽  
David Classen ◽  
Gitte Larsen ◽  
Nancy M. Tofil ◽  
Leslie W. Hayes ◽  
...  
Keyword(s):  
United States ◽  
Intensive Care ◽  
Adverse Events ◽  
Intensive Care Units ◽  
Pediatric Intensive Care ◽  
The United States ◽  
Pediatric Intensive Care Units

scholarly journals Investigation of a Contaminated, Nationally Distributed, Organ Transplant Preservation Solution — United States, 2016–2017

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S11-S11
Author(s):  
Matthew Stuckey ◽  
Shannon Novosad ◽  
Nancy Wilde ◽  
Pallavi Annambhotla ◽  
Sridhar Basavaraju ◽  
...  
Keyword(s):  
United States ◽  
Adverse Events ◽  
Infection Control ◽  
Bacterial Contamination ◽  
Organ Procurement ◽  
The United States ◽  
Patient Harm ◽  
Preservation Solution ◽  
Public Health Action ◽  
Transplant Center

Abstract Background In December 2016, bacterial contamination of an organ preservation solution (OPS) was reported by Transplant Center A in Iowa. Annually, &gt;20,000 abdominal organs are transplanted in the United States; OPS is used for organ storage. We investigated the scope of OPS contamination and its association with adverse events in patients. Methods We assessed infection control practices related to OPS at Transplant Centers A and B in Iowa and the local organ procurement organization (OPO). We issued national notifications about OPS contamination and requested transplant centers to report product-related concerns or potential patient harm. Among transplant recipients at Center A, we compared adverse events (fever, bacteremia, surgical site infection, peritonitis, or pyelonephritis within 14 days of transplantation) during October–December 2015 with October–December 2016, the presumed window of exposure to contaminated OPS. Isolates from OPS were characterized. Results No infection control deficiencies were identified at Transplant Centers A, B, or the OPO. In January 2017, contaminated OPS from the same manufacturer was reported by Transplant Center C in Texas. Nationally, there were no reports of patient harm definitively linked to OPS. Post-transplant adverse events at Center A did not increase between fourth quarter 2015 (5/12 [42%]) and 2016 (2/15 [13%]). Organisms recovered from OPS included Pantoea agglomerans and Enterococcus gallinarum (Center A) and Pseudomonas koreensis (Center C). Five Pantoea isolates from ≥3 opened OPS bags were indistinguishable by pulsed-field gel electrophoresis. The OPS distributor issued recalls and suspended production. The US Food and Drug Administration identified deficiencies in current good manufacturing practices at manufacturing and distribution facilities, including inadequate validation of OPS sterility. Conclusion Bacterial contamination of a nationally distributed product was identified by astute clinicians. The investigation found no illnesses were directly linked to the product. Prompt reporting of concerns about potentially contaminated healthcare products, which might put patients at risk, is critical for swift public health action. Disclosures All authors: No reported disclosures.

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