scholarly journals Post-Marketing Safety Profile of Vortioxetine Using a Cluster Analysis and a Disproportionality Analysis of Global Adverse Event Reports

Drug Safety ◽  
2022 ◽  
Author(s):  
Corine Ekhart ◽  
Florence van Hunsel ◽  
Eugène van Puijenbroek ◽  
Rebecca Chandler ◽  
Eva-Lisa Meldau ◽  
...  
Keyword(s):  
Cluster Analysis ◽  
Adverse Event ◽  
Safety Profile ◽  
Disproportionality Analysis ◽  
Post Marketing

scholarly journals The Safety Profile of Vedolizumab in Ulcerative Colitis and Crohn’s Disease: 4 Years of Global Post-marketing Data

2019 ◽  
Vol 14 (2) ◽  
pp. 192-204 ◽  
Author(s):  
Russell D Cohen ◽  
Fatima Bhayat ◽  
Aimee Blake ◽  
Simon Travis
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Event ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
Safety Profile ◽  
Safety Data ◽  
Real World Data ◽  
Safety Database ◽  
Post Marketing

Abstract Background and Aims Vedolizumab is a gut-selective antibody to α 4  β 7 integrin, approved to treat moderate-to-severe ulcerative colitis and Crohn’s disease in adults. Clinical trial data on patients meeting protocol-specified criteria may not reflect real-world clinical practice. This is a descriptive analysis of 4 years of post-marketing safety data on vedolizumab. Methods The Vedolizumab Global Safety Database contains all adverse event reports collated by Takeda Pharmaceutical Company Ltd since vedolizumab approval [May 20, 2014]. Adverse event reports received between approval and May 19, 2018 were identified using Medical Dictionary for Regulatory Activities version 21.0 Preferred Terms. Adverse event frequencies were calculated and categorised. Results In approximately 208 050 patient-years of vedolizumab exposure, 32 752 patients reported 80 218 events. In patients with Crohn’s disease or ulcerative colitis, 37 662 and 34 259 events occurred in 14 191 and 14 042 patients, respectively, and 8297 events occurred in 4519 individuals with other [off-label] or unreported indications. Overall, 5230 [14%; Crohn’s disease] and 3580 [10%; ulcerative colitis] events were serious. Most frequently reported were gastrointestinal events (Crohn’s disease, 6156 [16%]; ulcerative colitis, 5701 [17%]). Patients with Crohn’s disease or ulcerative colitis reported 251 malignancies [<1%], 402 hepatobiliary events [<1%], and 5876 infections (1137 serious [19%], 301 opportunistic [5%]). Patients aged ≥70 years [2326 patients] reported <10% of events. Conclusions Adverse event patterns were consistent with clinical trials, with no new safety concerns. Most reported events were non-serious and event frequency was low, considering patient-years of exposure. Although limitations of post-marketing safety reports require acknowledgement, these real-world data support a favourable safety profile of vedolizumab.

Novel Adverse Events of Iloperidone: A Disproportionality Analysis in US Food and Drug Administration Adverse Event Reporting System (FAERS) Database

2019 ◽  
Vol 14 (1) ◽  
pp. 21-26 ◽  
Author(s):  
Viswam Subeesh ◽  
Eswaran Maheswari ◽  
Hemendra Singh ◽  
Thomas Elsa Beulah ◽  
Ann Mary Swaroop
Keyword(s):  
Data Mining ◽  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Disproportionality Analysis ◽  
Positive Signal ◽  
Data Mining Algorithms ◽  
Mining Algorithms

Background: The signal is defined as “reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously”. Objective: To detect novel adverse events of iloperidone by disproportionality analysis in FDA database of Adverse Event Reporting System (FAERS) using Data Mining Algorithms (DMAs). Methodology: The US FAERS database consists of 1028 iloperidone associated Drug Event Combinations (DECs) which were reported from 2010 Q1 to 2016 Q3. We consider DECs for disproportionality analysis only if a minimum of ten reports are present in database for the given adverse event and which were not detected earlier (in clinical trials). Two data mining algorithms, namely, Reporting Odds Ratio (ROR) and Information Component (IC) were applied retrospectively in the aforementioned time period. A value of ROR-1.96SE>1 and IC- 2SD>0 were considered as the threshold for positive signal. Results: The mean age of the patients of iloperidone associated events was found to be 44years [95% CI: 36-51], nevertheless age was not mentioned in twenty-one reports. The data mining algorithms exhibited positive signal for akathisia (ROR-1.96SE=43.15, IC-2SD=2.99), dyskinesia (21.24, 3.06), peripheral oedema (6.67,1.08), priapism (425.7,9.09) and sexual dysfunction (26.6-1.5) upon analysis as those were well above the pre-set threshold. Conclusion: Iloperidone associated five potential signals were generated by data mining in the FDA AERS database. The result requires an integration of further clinical surveillance for the quantification and validation of possible risks for the adverse events reported of iloperidone.

Drug-induced neuropsychiatric adverse events using post-marketing surveillance

2021 ◽  
Vol 16 ◽  
Author(s):  
Tomohito Wakabayashi ◽  
Takahiro Nakatsuji ◽  
Hiroko Kambara ◽  
Iku Niinomi ◽  
Saki Oyama ◽  
...  
Keyword(s):  
Spontaneous Reporting ◽  
Abnormal Behavior ◽  
Drug Event ◽  
Reporting Odds Ratio ◽  
Neuraminidase Inhibitors ◽  
Disproportionality Analysis ◽  
Drug Induced ◽  
Real World Setting ◽  
Post Marketing Surveillance ◽  
Post Marketing

Background: Several studies reported that abnormal behavior was noted in pediatric patients receiving several drugs including neuraminidase inhibitors (NIs). However, information on drugs associated with abnormal behavior in a real-world setting remains limited. The purpose of this study was to clarify drugs associated with abnormal behavior using a spontaneous reporting system database. Methods: We performed a retrospective pharmacovigilance disproportionality analysis using the Japanese Adverse Drug Event Report database. Adverse event reports submitted to the Pharmaceuticals and Medical Devices Agency were analyzed. Drug associated with abnormal behavior were estimated using disproportionality analysis with calculation of the reporting odds ratio and 95% confidence interval. Results: A total of 1,144 reports of abnormal behavior were identified. Signals were detected showing the association of 4 including neuraminidase inhibitors (oseltamivir, zanamivir, laninamivir, and peramivir) with abnormal behavior, and these signals were stronger for oseltamivir than other neuraminidase inhibitors. Signals were also detected for acetaminophen and montelukast. Conclusion: Our results should raise physicians’ awareness of drugs associated with abnormal behavior, but further investigation of these medications is warranted.

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

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