A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims [PDF]
, 2007 This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why ...
Kessler, David A., Vladeck, David C.
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PRE-MARKET CLINICAL EVALUATIONS OF INNOVATIVE HIGH-RISK MEDICAL DEVICES IN EUROPE [PDF]
, 2012 Objectives:High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US ...
Abrishami, P. +12 more
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Proton-pump inhibitor use is associated with a broad spectrum of neurological adverse events including impaired hearing, vision, and memory. [PDF]
, 2019 Proton-pump inhibitors, PPIs, are considered effective therapy for stomach acid suppression due to their irreversible inhibition of the hydrogen/potassium pump in the gastric parietal cells. They are widely prescribed and are considered safe for over-the-
Abagyan, Ruben +4 more
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Squamous-cell carcinoma of the tongue following therapy of rheumatoid arthritis with abatacept [PDF]
, 2014 A patient affected by rheumatoid arthritis developed a squamous-cell carcinoma probably due to abatacept, according to Naranjo algorithm. The case describes this adverse reaction for the first time and highlights the need for additional studies to ...
Deidda, Arianna +7 more
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Recent advances: rheumatology [PDF]
, 2000 No abstract ...
Madhok, R., Kerr, H., Capell, H.A.
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Clinical perspectives of emerging pathogens in bleeding disorders. [PDF]
, 2006 As a result of immunological and nucleic-acid screening of plasma donations for transfusion-transmissible viruses, and the incorporation of viral reduction processes during plasma fractionation, coagulation-factor concentrates (CFC) are now judged safe ...
Bozzette, Samuel +11 more
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Glycoprotein IIb/IIIa Inhibitors Use and Outcome after Percutaneous Coronary Intervention for Non-ST Elevation Myocardial Infarction [PDF]
, 2014 Aims. We investigate the effect of glycoprotein IIb/IIIa (GP IIb/IIIa) inhibitors on long-term outcomes following percutaneous coronary intervention (PCI) after non-ST elevation myocardial infarction (NSTEMI). Meta-analyses indicate that these agents are
Antoniou, S +9 more
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Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China [PDF]
, 2013 Daniel Kramer and colleagues compare strategies for postmarket surveillance of medical devices and discuss ways to improve these systems.
Kesselheim, Aaron S. +3 more
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Retrospective analysis reveals significant association of hypoglycemia with tramadol and methadone in contrast to other opioids. [PDF]
, 2019 Tramadol is one of the most commonly used analgesics worldwide, classified as having a low abuse potential by U.S. Drug Enforcement Agency, and often recommended in pain management guidelines.
Abagyan, Ruben +3 more
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Pulmonary Hypertension and Other Potentially Fatal Pulmonary Complications in Systemic Juvenile Idiopathic Arthritis [PDF]
, 2012 Objective Systemic juvenile idiopathic arthritis (JIA) is characterized by fevers, rash, and arthritis, for which interleukin‐1 (IL‐1) and IL‐6 inhibitors appear to be effective treatments.
Carol A. Wallace +19 more
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