Results 91 to 100 of about 13,126 (223)

Oral Bisphosphonates and Risk of Atrial Fibrillation and Flutter in Women: A Self-Controlled Case-Series Safety Analysis [PDF]

, 2009
Background: A recent trial unexpectedly reported that atrial fibrillation, when defined as serious, occurred more often in participants randomized to an annual infusion of the relatively new parenteral bisphosphonate, zoledronic acid, than among those ...
Aroon Hingorani, Douglas, I, Hingorani, A, Douglas, Ian, MacAllister, Raymond, Grosso, Anthony, MacAllister, R, Anthony Grosso, Liam Smeeth, Smeeth, Liam, Raymond MacAllister, Grosso, A, Smeeth, L, Ian Douglas, Hingorani, Aroon   +14 more
core   +1 more source

Assessment of malignancy risk in patients with multiple sclerosis treated with intramuscular interferon beta-1a: retrospective evaluation using a health insurance claims database and postmarketing surveillance data

Therapeutics and Clinical Risk Management, 2012
Gary Bloomgren, Bjørn Sperling, Kimberly Cushing, Madé WentenBiogen Idec Inc., Weston, MA, USABackground: Intramuscular interferon beta-1a (IFNβ-1a), a multiple sclerosis (MS) therapy that has been commercially available ...
Bloomgren G, Sperling B, Cushing K, Wenten M   +3 more
doaj  

Factors That Influence FDA Decisions for Postmarketing Requirements and Commitments During Review of Oncology Products

, 2018
Purpose: With the recent use of expedited drug development and approval programs for several oncology products in the United States, the importance of postmarketing plans to confirm clinical benefits and safety is increasing.
Atsushi Hyogo, Masayuki Kaneko, Mamoru Narukawa   +2 more
core   +1 more source

Monitoring drug safety with registries: useful components of postmarketing pharmacovigilance systems

, 2012
ObjectiveAt the time of licensing by regulatory agencies, the full range of risks and possible adverse drug reactions associated with a medication is rarely fully realized.
Cameron, P., Willis, C., Louise E. Phillips, Cameron D. Willis, McNeil, J., John J. McNeil, Peter A. Cameron, Phillips, L.   +7 more
core   +1 more source

EFFECTIVENESS AND SAFETY OF 1% PIMECROLIMUS CREAM AS APPLIED AMONG CHILDREN WITH ATOPIC DERMATITIS

Педиатрическая фармакология, 2009
The article highlights the findings of the open surveying uncontrolled multicentric postmarketing research to study the effectiveness and safety of 1% pimecrolimus cream as applied among children aged over months, suffering from atopic dermatitis.
K.E. Efendieva, Yu.G. Levina, L.S. Namazova-Baranova   +2 more
doaj   +2 more sources

Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the STANDARD study

Journal of Arrhythmia, 2019
Background Apixaban, a non‐vitamin K oral anticoagulant (NOAC), was approved in Japan in 2012 for the prevention of thromboembolic events in patients with nonvalvular atrial fibrillation (NVAF).
Hiroshi Inoue, Michiaki Umeyama, Takako Yamada, Hiroyuki Hashimoto, Akira Komoto, Masahiro Yasaka   +5 more
doaj   +1 more source

Postmarketing safety evaluation of belimumab: a pharmacovigilance analysis

Lupus Science and Medicine
Objective The present study aimed to provide a comprehensive evaluation of the postmarketing safety of belimumab based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database.Methods Adverse event (AE) reports in the FAERS ...
Huqun Li, Wenlong Xie, Chongshu Wang, Cuilian Guo   +3 more
doaj   +1 more source

Characteristics of “Hard-to-Use” Press-Through-Package Sheets: An Analysis of Information Collected by Marketing Specialists of a Japanese Medical Wholesaler

Patient Preference and Adherence, 2020
Kenji Kabeya,1 Hiroki Satoh,2,3 Satoko Hori,4 Yasumasa Miura,5 Yasufumi Sawada2 1Faculty of Pharmaceutical Sciences, The University of Tokyo, Tokyo 113-0033, Japan; 2Laboratory of Drug Lifetime Management, Graduate School of Pharmaceutical Sciences, The ...
Kabeya K, Satoh H, Hori S, Miura Y, Sawada Y   +4 more
doaj  

Postmarket Surveillance of Neuroendovascular Devices

Stroke: Vascular and Interventional Neurology
Endovascular devices have catalyzed a global industry for advanced technologies such as flow diverters and stent retrievers. Though adoption of these devices has skyrocketed over the past 30 years, the regulatory landscape for real‐world monitoring is constantly under revision.
Marie K. Luff, Art Sedrakyan, Sameer A. Ansari, Adnan H. Siddiqui, David S. Liebeskind   +4 more
openaire   +3 more sources

Information, Learning, and Drug Diffusion: the Case of Cox-2 Inhibitors [PDF]

The recent withdrawal of Cox-2 Inhibitors has generated debate on the role of information in drug diffusion: can the market learn the efficacy of new drugs, or does it depend solely on manufacturer advertising and FDA updates?
Pradeep Chintadunta, Ginger Z. Jin, Renna Jiang   +2 more
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