scholarly journals Pioglitazone and Sitagliptin: An Urgent Call for New Regulations Controlling all the Post Marketing Drug Safety Studies

Author(s):  
Kelleni M T
2014 ◽  
Vol 70 (3) ◽  
pp. 311
Author(s):  
Matthew Abernathy ◽  
Brian Wilson ◽  
Joshua Yoder ◽  
Rachel Tapp ◽  
David Gauvin ◽  
...  

Drug Safety ◽  
2017 ◽  
Vol 41 (1) ◽  
pp. 125-137 ◽  
Author(s):  
Yu Yang ◽  
Xiaofeng Zhou ◽  
Shuangqing Gao ◽  
Hongbo Lin ◽  
Yanming Xie ◽  
...  

BMJ ◽  
2017 ◽  
pp. j337 ◽  
Author(s):  
Angela Spelsberg ◽  
Christof Prugger ◽  
Peter Doshi ◽  
Kerstin Ostrowski ◽  
Thomas Witte ◽  
...  

Author(s):  
Homero Contreras-Salinas ◽  
Leopoldo Martín Baiza-Durán ◽  
Mariana Barajas-Hernández ◽  
Alan Omar Vázquez-Álvarez ◽  
Lourdes Yolotzin Rodríguez-Herrera

(1) Background: drugs provide a significant benefit; however, their use implies an intrinsic potential danger, with the possibility to cause unwanted effects. These effects are known as adverse drug reactions (ADRs). Post-marketing drug safety surveillance detects unknown risks that have not been identified in clinical trials and it is necessary to monitor marketed medications under real-life practice. Due to the scarce information about fixed combination of ciprofloxacin 0.3% / dexamethasone 0.1% (SDO), we performed a drug safety surveillance study. (2) Methods: A prospective non-controlled drug safety surveillance study was conducted in Peruvian population. A total of 236 patients prescribed SDO were included derivates from 12 sites. Patients' standardized information was collected through two phone calls, including demographics, medical history, prescribing patterns of SDO, concomitant medication, and ADRs in detail. The ADRs were classified by causality and severity, followed by outcome measures to identify new risk. (3) Results: 236 patients prescribed with SDO participated in the study and 220 were included. A total of 82 ADRs/220 patients were reported after the use of SDO, presenting a ratio 0.37 ADR/patient. The most frequent ADR with SDO administration was eye irritation (30%). The totality of the ADR was classified as non-serious, and the 97.5% (n=80) was classified as mild and 2.5% as moderate (n=2). No cases under the severe category were identified. (4) Conclusion: No new risks were found in the population where this study was conducted.


1990 ◽  
Vol 16 (12) ◽  
pp. 1893-1909 ◽  
Author(s):  
David Johnston ◽  
Martin R. Gray ◽  
Colin S. Reed ◽  
Frank W. Bonner ◽  
Nicholas H. Anderson

1995 ◽  
Vol 23 (2) ◽  
pp. 199-208 ◽  
Author(s):  
Steven A. Wrighton ◽  
Barbara J. Ring ◽  
Mark Vandenbranden

2008 ◽  
Vol 17 (12) ◽  
pp. 1226-1234 ◽  
Author(s):  
Priscilla Velentgas ◽  
Rhonda L. Bohn ◽  
Jeffrey S. Brown ◽  
K. Arnold Chan ◽  
Patricia Gladowski ◽  
...  

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