Contemporary post‐marketing adverse events and modes of failure related to VASCADE Vascular Closure System: The utility of the MAUDE database

2021 ◽  
Author(s):  
Brian C. Case ◽  
Sant Kumar ◽  
Giorgio A. Medranda ◽  
Charan Yerasi ◽  
Brian J. Forrestal ◽  
...  
Keyword(s):  
Adverse Events ◽  
Closure System ◽  
Modes Of Failure ◽  
Post Marketing

scholarly journals AB0249 SAFETY OF BARICITINIB IN JAPANESE PATIENTS WITH RHEUMATOID ARTHRITIS (RA): THE 2020 INTERIM REPORT FROM ALL-CASE POST MARKETING SURVEILLANCE IN CLINICAL PRACTICE

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1150.1-1150
Author(s):  
T. Fujii ◽  
T. Atsumi ◽  
N. Okamoto ◽  
N. Takahashi ◽  
N. Tamura ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Aspiration Pneumonia ◽  
Japanese Patients ◽  
Research Support ◽  
Serious Adverse Events ◽  
Chugai Pharmaceutical ◽  
Post Marketing Surveillance ◽  
Otsuka Pharmaceutical ◽  
Post Marketing

Background:An all-case post marketing surveillance (PMS) of baricitinib (Bari), that started in Sep 2017, collects safety and effectiveness for the first 24 wks of treatment and continues to collect serious adverse events (SAEs) for 3 yrs.Objectives:To evaluate Bari safety in RA patients (pt) in clinical practice.Methods:We report pt baseline demographics and adverse events (AEs) up to 24 wks for pts whose case report files for 24-wk data were completed as of Jun 2020.Results:Data from 3445 pts were analyzed (females=80%, mean age=64yr, mean RA duration 12yr). Bari dose regimen was as follows: 4mg, 60%, 2mg, 27%, 4mg→2mg, 5%, 2mg→4mg, 5%, and others, 2%. Concomitant use of MTX and glucocorticoid was 65% and 48%, respectively. 74% continued treatment for 24 wks. AE and SAE were recognized in 887 (26%) and 122 pts (4%), respectively. 6 pts died of pneumonia, aspiration pneumonia, bacterial pneumonia, cerebral infarction/ILD/aspiration pneumonia, adenocarcinoma, and colorectal cancer. Major AEs were as follows: herpes zoster=3%, liver dysfunction=3%, serious infection=1%, anemia=1%, hyperlipidemia=1%, malignancy=0.3%, interstitial pneumonia=0.2%, MACE=0.1%, and VTE=0.1%.Conclusion:Data do not show new safety concerns and encourage guideline-compliant use of Bari.Disclosure of Interests:Takao Fujii Speakers bureau: Chugai Pharmaceutical Co. Ltd.; Eisai Co. Ltd; Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K.; Ono Pharmaceutical Co. Ltd., Consultant of: Asahikasei Pharma Corp, Grant/research support from: Asahikasei Pharma Corp; AbbVie Japan GK; Chugai Pharmaceutical Co. Ltd., Eisai Co. Ltd; Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Co.; Ono Pharmaceutical Co., Ltd., Tatsuya Atsumi Speakers bureau: AbbVie Japan GK; Astellas Pharma Inc.; Bristol-Myers Squibb Co. Ltd; Chugai Pharmaceutical Co. Ltd.; Daiichi Sankyo Co. Ltd.; Eisai Co. Ltd.; Eli Lilly Japan K.K.; Mitsubishi Tanabe Pharma Co.; Pfizer Japan Inc.; Takeda Pharmaceutical Co. Ltd., UCB Japan Co. Ltd., Consultant of: AbbVie Japan GK; AstraZeneca plc.; Boehringer Ingelheim Co. Ltd.; Medical & Biological Laboratories Co. Ltd.; Novartis Pharma K.K.; Ono Pharmaceutical Co. Ltd.; Pfizer Japan Inc., Grant/research support from: Astellas Pharma Inc., Alexion Inc.; Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Mitsubishi Tanabe Pharma Co., Otsuka Pharmaceutical Co., Ltd.Pfizer Japan Inc.; Takeda Pharmaceutical Co. Ltd., Nami Okamoto Speakers bureau: AbbVie Japan GK; Asahikasei Pharma Co.; AYUMI Pharmaceutical Co.Eisai Co. Ltd; Bristol-Myers Squibb Co. Ltd.; Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Co.; Pfizer Japan Inc.Sanofi K.K.; Chugai Pharmaceutical Co. Ltd.; Novartis Pharma Co.; Teijin Pharma Ltd.; Torii Pharmaceutical Co., Ltd., Nobunori Takahashi Speakers bureau: AbbVie Japan GK; Eisai Co. Ltd.; Mitsubishi Tanabe Pharma Co.; Pfizer Japan Inc.; Chugai Pharmaceutical Co., Ltd.; Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K.; UCB Japan Co. Ltd.; Astellas Pharma Inc.; Bristol Myers Squibb Co. Ltd., Grant/research support from: Bristol Myers Squibb Co. Ltd., Naoto Tamura Speakers bureau: AbbVie Japan GK; Bristol Myers Squibb Co. Ltd.; Chugai Pharmaceutical Co. Ltd.; Eisai Co. Ltd.; Eli Lilly Japan K.K.; Glaxo Smith Kline K.K.; Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Co.; Novartis Pharma Co., Atsuo Nakajima: None declared, Ayako Nakajima Speakers bureau: AbbVie Japan GK; Actelion Pharmaceuticals Japan Ltd., Asahi Kasei Pharma Co., Astellas Pharma Inc., Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd.,Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Glaxo Smith Kline K.K., Hisamitsu Pharmaceutical Co. Inc., Kyorin Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Co., Otsuka Pharmaceutical Co. Ltd., Pfizer Japan Inc., Teijin Pharma Ltd., Grant/research support from: Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Hiroaki Matsuno Speakers bureau: Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eli Lilly Japan K.K., Consultant of: Mochida Pharmaceutical Co., Ltd., Grant/research support from: Astellas Pharma Inc., Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K, Naoto Tsujimoto Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Atsushi Nishikawa Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Taeko Ishii Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Tsutomu Takeuchi Speakers bureau: AbbVie Japan GK, Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co, Ltd. Daiichi Sankyo Co., Ltd. Eisai Co., Ltd. Eli Lilly Japan K.K.; Gilead Sciences, Inc. Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Co.; Novartis Pharma Co.; Pfizer Japan Inc.; Sanofi K.K.; UCB Japan Co., Ltd., Consultant of: AbbVie Japan GK, Astellas Pharma, Inc.; Chugai Pharmaceutical Co, Ltd.; Eli Lilly Japan K.K.; Eisai Co., Ltd.; Gilead Sciences, Inc.; Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Corp., Pfizer Japan Inc., Grant/research support from: AbbVie Japan GK, Asahikasei Pharma Corp., Chugai Pharmaceutical Co, Ltd., DNA Chip Research Inc.; Eisai Co., Ltd., Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Corp., UCB Japan Co., Ltd., Masataka Kuwana Speakers bureau: AbbVie Japan GK, Astellas Pharma Inc., Asahi Kasei Pharma Co., Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Medical &Biological Laboratories Co., Ltd.; Mitsubishi Tanabe Pharma Co.; Mochida Pharmaceutical Co., Ltd., Nippon Shinyaku Co., Ltd.; Ono Pharmaceutical Co., Ltd.; Pfizer Japan Inc., Consultant of: Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Corbus Pharmaceuticals Holdings, Inc.; Medical &Biological Laboratories Co., Ltd.; Mochida Pharmaceutical Co., Ltd., Grant/research support from: Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Medical &Biological Laboratories Co., Ltd; Mitsubishi Tanabe Pharma Co., Ono Pharmaceutical Co., Ltd., Michiaki Takagi Speakers bureau: Yes, but sponsored lectures without COI in the academic meetings, only.

Safety and tolerability of prescribed usage of Derise® (Darbepoetin Alfa, Hetero) in symptomatic anemia: A Post Marketing Surveillance Study

2020 ◽  
Author(s):  
Shubhadeep Sinha ◽  
Vamsi Krishna Bandi ◽  
Bala Reddy Bheemareddy ◽  
Pankaj Thakur ◽  
Sreenivasa Chary ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Adverse Events ◽  
Darbepoetin Alfa ◽  
P Value ◽  
End Of Treatment ◽  
Post Marketing Surveillance ◽  
Post Marketing

Abstract Background This post marketing surveillance, observational, prospective, safety study evaluated the safety, tolerability and long term immunogenicity of prescribed usage of Darbepoetin alfa, (DA-α, manufactured by Hetero Biopharma) in Indian patients with chronic kidney disease with anemia.Methods All patients with anemia of chronic kidney disease prescribed Hetero-Darbepoetin were the target patient population. The present study gathered the data from 503 Hetero-Darbepoetin alfa prescribed patients. This study collected information of patient demography, patient's medical history, concomitant medications, action taken with respect to Hetero-Darbepoetin-alfa, AE details (AE term, start date, stop date, severity, action taken, outcome and causality), periodic Hemoglobin (Hb) levels and abnormal laboratory tests results until treatment is discontinued or the patient is lost to follow-up. Immunogenicity data was collected in 121 patients at the end of treatment and after 1 year. Statistical analyses were performed to explore and analyze details of individual case safety reports of adverse events such as incidence, severity, seriousness, outcome, duration, action taken, and causality relationship of individual adverse event (AE) to the prescribed study drug. Results 87 AEs were reported in this study and most of them were mild to moderate in intensity. No deaths or serious adverse events (SAEs) were reported in this study. Anti-drug antibodies were not detected in any subject at the end of treatment phase and after 12 months long term follow up period. Baseline mean Hemoglobin value was 8.34 (SD 1.24) g/dL and last visit mean Hemoglobin value was 10.42 (SD 1.28) g/dL. The mean difference between baseline and last visit was 2.10 [2.00, 2.20], statistically significant (p-value <.0001). Conclusions The safety and tolerability of the usage of DA-α (manufactured by Hetero Biopharma) is similar to that reported in the published literature of the innovator. No patients showed anti-drug antibodies after treatment. Additionally, the patients also showed significant improvement in hemoglobin levels, compared to baseline.Clinical Trial Registry Number: CTRI/2017/04/008338 [Registered on CTRI http://ctri.nic.in/Clinicaltrials/login.php : 12/04/2017]; Trial Registered Retrospectively

scholarly journals 0471 24-Month Post Marketing Safety Surveillance Data of a Novel Continuous Release and Absorption Melatonin (CRA-Melatonin) Delivery System, Confirms Favorable Safety Profile

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A180-A181
Author(s):  
D Brodner ◽  
P Corsino
Keyword(s):  
Adverse Events ◽  
Safety Profile ◽  
Call Center ◽  
First Generation ◽  
Surveillance Period ◽  
Continuous Release ◽  
Safety Surveillance ◽  
Post Marketing ◽  
Favorable Safety ◽  
Reporting Rates

Abstract Introduction The awareness of sleep disorders having negative health consequences, including hypertension, diabetes, obesity, depression, heart attack and stroke, has sharply escalated in recent years. Traditional treatments, including benzodiazepenes, non-benzodiazepenes, anti-depressants and non-prescription first-generation antihistamines, come with limitations in efficacy, safety and tolerability. The search for non-drug alternatives continues. The novel, well tolerated CRA-melatonin was shown in a randomized, crossover, pharmacokinetic (PK) study versus the leading marketed melatonin to achieve quick uptake and then continuous release and absorption for up to 7 hours. No safety or tolerability issues were observed. The Remfresh Safety Update at 24 months (REMSU24), a real-world safety surveillance study was conducted to confirm the previously observed safety profile of CRA-melatonin. Methods An independent call center with pharmacovigilance-trained health care personnel in accordance with FDA guidelines on properly reporting events, was retained to receive and record customer questions, product issues and adverse events (AEs). The study was conducted from March 9, 2017 to March 9, 2019. Results An estimated 320,255 patients used CRA-melatonin during the surveillance period. There were no serious AEs. The self-reporting rates of non-serious AEs were low with only 51 events recorded, a 0.016% event rate. The two most frequent AEs, headaches and nightmares are known comorbidities of insomnia. As background, there had been no treatment emergent adverse events for CRA-melatonin in the PK trial. Conclusion CRA-melatonin’s extended 7-hour PK profile may be an effective and well-tolerated baseline therapy to improve sleep. These results confirm the favorable safety and tolerability trend observed in the PK study. In REMSU24, the scatter of reported adverse events could not be separated from what could be expected in the untreated general population. Support This study was supported by Physician’s Seal LLC

scholarly journals The ability of animal studies to detect serious post marketing adverse events is limited

2012 ◽  
Vol 64 (3) ◽  
pp. 345-349 ◽  
Author(s):  
Peter J.K. van Meer ◽  
Marlous Kooijman ◽  
Christine C. Gispen-de Wied ◽  
Ellen H.M. Moors ◽  
Huub Schellekens
Keyword(s):  
Adverse Events ◽  
Animal Studies ◽  
Post Marketing

Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients

2019 ◽  
Vol 61 (7) ◽  
pp. 910-920 ◽  
Author(s):  
Joachim Braun ◽  
Reinhard Busse ◽  
Elisabeth Darmon-Kern ◽  
Oliver Heine ◽  
Jonas Auer ◽  
...  
Keyword(s):  
Adverse Events ◽  
Contrast Agent ◽  
Daily Practice ◽  
Routine Practice ◽  
Serious Adverse Events ◽  
Diagnostic Efficacy ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Baseline Characteristics ◽  
Magnetic Resonance Imaging Mri

Background Magnetic resonance imaging (MRI) examinations with intravenous (IV) contrast are performed worldwide in routine daily practice. In order to detect and enumerate even rare adverse events (AE) and serious adverse events (SAE), and to relate them with patients’ baseline characteristics and diagnostic effectiveness, high quantity sample size is necessary. Purpose To assess safety, diagnostic effectiveness, and baseline characteristics of patients undergoing IV gadoteric acid (Dotarem®) MRI in routine practice. Material and Methods Data from two observational post-marketing surveillance (PMS) databases compiled by 139 and 52 German centers in 2004–2011 and 2011–2013, respectively, were pooled, yielding data on a total of 148,489 patients examined over a 10-year period. Radiologists used a standardized questionnaire to report data including patient demographics, characteristics of MR examinations, and results in terms of diagnosis and patient safety. Results Overall, 712 AEs were reported in 467 (0.3%) patients, mainly nausea (n = 224, 0.2%), vomiting (n = 29, <0.1%), urticaria (n = 20, <0.1%), and feeling hot (n = 13, <0.1%). AEs were considered related to gadoteric acid in 362 (0.2%) patients. Higher frequencies of AEs were observed among patients with a previous reaction to a contrast agent (2.0%), liver dysfunction (0.7%), bronchial asthma (0.7%), and a history of allergies (0.6%). There were 49 SAEs in 18 (<0.1%) patients, including two children. No fatal SAE was reported. Examinations were diagnostic in 99.8% of all patients, and image quality was excellent or good in 97.7% of the patients. Conclusion Gadoteric acid is a safe peri-examinational and effective contrast agent for MRI in routine practice.

scholarly journals Pharmacovigilance of Biopharmaceuticals in Rheumatic Diseases, Adverse Events, Evolution, and Perspective: An Overview

Biomedicines ◽  
2020 ◽  
Vol 8 (9) ◽  
pp. 303
Author(s):  
Sandra Rodríguez ◽  
Andrés Muñoz ◽  
Rosa-Helena Bustos ◽  
Diego Jaimes
Keyword(s):  
Rheumatoid Arthritis ◽  
Systemic Lupus Erythematosus ◽  
Adverse Events ◽  
Rheumatic Diseases ◽  
Lupus Erythematosus ◽  
Cell Mediated Immunity ◽  
Systemic Lupus ◽  
Biological Drugs ◽  
Necrosis Factor Alpha ◽  
Post Marketing

Since we have gained an understanding of the immunological pathophysiology of rheumatic diseases such as rheumatoid arthritis and systemic lupus erythematosus, treatment based on biological drugs has become a fundamental axis. These therapies are oriented towards the regulation of cytokines such as tumour necrosis factor-alpha (TNF-α), interleukin (IL)-6, IL-1, and the modulation of cell-mediated immunity (B cells and T cells) by anti CD20 or anti CTAL-4 agents, and can increase the risk of associated infections or adverse events (AE). In this context, the entry of biotherapeutics represented a challenge for pharmacovigilance, risk management and approval by the main global regulatory agencies regarding biosimilars, where efficacy and safety are based on comparability exercises without being an exact copy in terms of molecular structure. The objective of this review is divided into three fundamental aspects: (i) to illustrate the evolution and focus of pharmacovigilance at the biopharmaceutical level, (ii) to describe the different approved recommendations of biopharmaceuticals (biological and biosimilars) and their use in rheumatic diseases (RDs) such as rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE) and other less frequent RD like cryopyrin-associated autoinflammatory syndromes (CAPS), and (iii) to identify the main AE reported in the post-marketing phase of RD biopharmaceuticals.

Adverse Events and Modes of Failure Related to Impella RP: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database

2019 ◽  
Vol 20 (6) ◽  
pp. 503-506 ◽  
Author(s):  
Nauman Khalid ◽  
Toby Rogers ◽  
Evan Shlofmitz ◽  
Yuefeng Chen ◽  
Anees Musallam ◽  
...  
Keyword(s):  
Adverse Events ◽  
Modes Of Failure ◽  
User Facility
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