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Europace : European Pacing,... Aug 2014
Topics: Arrhythmias, Cardiac; Decision Support Techniques; Defibrillators, Implantable; Electric Countershock; Humans; Medical Device Recalls; Prosthesis Failure
PubMed: 24906608
DOI: 10.1093/europace/euu134 -
The Veterinary Clinics of North... Mar 2012Most pet foods are safe, but incidents of chemical contamination occur and lead to illness and recalls. There were 11 major pet food recalls in the United States between... (Review)
Review
Most pet foods are safe, but incidents of chemical contamination occur and lead to illness and recalls. There were 11 major pet food recalls in the United States between 1996 and 2010 that were due to chemical contaminants or misformulations: 3 aflatoxin, 3 excess vitamin D3, 1 excess methionine, 3 inadequate thiamine, and 1 adulteration with melamine and related compounds and an additional 2 warnings concerning a Fanconilike renal syndrome in dogs after ingesting large amounts of chicken jerky treat products. This article describes clinical findings and treatment of animals exposed to the most common pet food contaminants.
Topics: Animals; Cat Diseases; Cats; Dog Diseases; Dogs; Food Contamination; Foodborne Diseases; Product Recalls and Withdrawals
PubMed: 22381176
DOI: 10.1016/j.cvsm.2011.12.007 -
The Medical Journal of Australia Jun 2010
Topics: Anti-Obesity Agents; Australia; Chemical and Drug Induced Liver Injury; Humans; Plant Preparations; Safety-Based Drug Withdrawals
PubMed: 20528725
DOI: 10.5694/j.1326-5377.2010.tb03677.x -
PloS One 2017Poor recall during investigations of foodborne outbreaks may lead to misclassifications in exposure ascertainment. We conducted a simulation study to assess the...
Assessment of recall error in self-reported food consumption histories among adults-Particularly delay of interviews decrease completeness of food histories-Germany, 2013.
INTRODUCTION
Poor recall during investigations of foodborne outbreaks may lead to misclassifications in exposure ascertainment. We conducted a simulation study to assess the frequency and determinants of recall errors.
METHODS
Lunch visitors in a cafeteria using exclusively cashless payment reported their consumption of 13 food servings available daily in the three preceding weeks using a self-administered paper-questionnaire. We validated this information using electronic payment information. We calculated associated factors on misclassification of recall according to time, age, sex, education level, dietary habits and type of servings.
RESULTS
We included 145/226 (64%) respondents who reported 27,095 consumed food items. Sensitivity of recall was 73%, specificity 96%. In multivariable analysis, for each additional day of recall period, the adjusted chance for false-negative recall increased by 8% (OR: 1.1;95%-CI: 1.06, 1.1), for false-positive recall by 3% (OR: 1.03;95%-CI: 1.02, 1.05), for indecisive recall by 12% (OR: 1.1;95%-CI: 1.08, 1.15). Sex and education-level had minor effects.
DISCUSSION
Forgetting to report consumed foods is more frequent than reporting food-items actually not consumed. Bad recall is strongly enhanced by delay of interviews and may make hypothesis generation and testing very challenging. Side dishes are more easily missed than main courses. If available, electronic payment data can improve food-history information.
Topics: Adult; Eating; Female; Food Safety; Germany; Humans; Male; Middle Aged; Product Recalls and Withdrawals; Self Report; Young Adult
PubMed: 28640839
DOI: 10.1371/journal.pone.0179121 -
Expert Opinion on Investigational Drugs Nov 2011The Pharmaceutical Industry is currently undergoing a period of rapid change as the pressures of the financial markets highlight fundamental inefficiencies in the...
The Pharmaceutical Industry is currently undergoing a period of rapid change as the pressures of the financial markets highlight fundamental inefficiencies in the current business model. The Achilles heel for the industry is the unacceptable level of attrition in clinical drug development. An imperative for the industry is to reduce the cost and increase the efficiency of Research and Development (R&D). This article provides an analysis of cancer drugs dropped from the industry pipeline in 2010 and offers a perspective on how the future oncology drug pipeline might evolve.
Topics: Antineoplastic Agents; Clinical Trials as Topic; Drug Discovery; Drug Industry; Humans; Product Recalls and Withdrawals; Research
PubMed: 21955127
DOI: 10.1517/13543784.2011.623697 -
Therapeutic Innovation & Regulatory... Jan 2019In this study we compared Swissmedic's (SMC's) regulatory marketing authorization decisions to those of the US Food and Drug Administration (FDA) and European drug... (Comparative Study)
Comparative Study Review
BACKGROUND
In this study we compared Swissmedic's (SMC's) regulatory marketing authorization decisions to those of the US Food and Drug Administration (FDA) and European drug regulatory authorities (EU). We investigated the overall similarity of the regulatory decisions, approval, and postmarketing withdrawal rates in the 3 jurisdictions. In case regulatory decisions diverged, we analyzed the reasons for rejection of marketing authorization applications (MAAs).
METHODS
The study comprises 255 new molecular entity (NME) MAAs assessed by SMC by the EU and FDA between 2005 through 2014. Study parameters included the regulatory decision, postmarketing withdrawal rates, and the official reasons for rejection.
RESULTS
Regulatory decisions converged to a high degree among all 3 agencies (between 84% and 90%). SMC's average approval rate (84%) was slightly lower than those of the FDA (87%) and the EU (91%). Postmarketing withdrawal rates were generally low (4%-5%) but were 3 to 5 times higher when decisions among the drug regulatory authorities (DRAs) diverged. SMC's primary grounds for rejection were lack of efficacy (45%) and safety (40%).
CONCLUSIONS
The 3 investigated DRAs adhere largely to the same scientific principles and regulatory guidelines; therefore, remaining disparities ought to be considered in a cultural, legal and public health priority context.
Topics: Decision Making; Drug Approval; European Union; Marketing; Product Surveillance, Postmarketing; Safety-Based Drug Withdrawals; Switzerland; United States; United States Food and Drug Administration
PubMed: 29714594
DOI: 10.1177/2168479018764660 -
Heart Rhythm Jun 2024
Review
Topics: Humans; Defibrillators, Implantable; Medical Device Recalls; Pacemaker, Artificial; Equipment Failure; Cardiac Electrophysiology
PubMed: 38403233
DOI: 10.1016/j.hrthm.2024.02.039 -
American Journal of Health-system... Sep 2015
Topics: Bupivacaine; Drug Contamination; Drug Recalls; Humans; Pharmacy Service, Hospital; Pharmacy Technicians
PubMed: 26294230
DOI: 10.2146/news150058 -
Haematologica Aug 2019
Topics: Female; Home Care Services; Humans; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Male; Protein Kinase Inhibitors; Safety-Based Drug Withdrawals
PubMed: 31366463
DOI: 10.3324/haematol.2019.222216 -
Journal of Addiction Medicine 2015Propoxyphene was withdrawn from the US market in November 2010. This drug is still tested for in the workplace as part of expanded panel nonregulated testing.
BACKGROUND
Propoxyphene was withdrawn from the US market in November 2010. This drug is still tested for in the workplace as part of expanded panel nonregulated testing.
METHODS
A convenience sample of urine specimens (n = 7838) were provided by workers from various industries. The percentage of positive specimens with 95% confidence intervals was calculated for each year of the study. Logistic regression was used to assess the impact of the year upon the propoxyphene result.
RESULTS
The prevalence of positive propoxyphene tests was much higher before the product's withdrawal from the market. Logistic regression provided evidence of a decreasing linear trend (P < 0.000; β = -0.71). The odds ratio signifies that for every additional year the urine specimens were 0.49 times less likely to be positive for propoxyphene.
CONCLUSIONS
This favors the determination that the change in propoxyphene positive drug test over the years is not by chance. The conclusion supports no longer performing nonregulated workplace propoxyphene urine drug testing for this population.
Topics: Analgesics, Opioid; Dextropropoxyphene; Humans; Midwestern United States; Retrospective Studies; Safety-Based Drug Withdrawals; Substance Abuse Detection; Workplace
PubMed: 25622125
DOI: 10.1097/ADM.0000000000000108