Mixed safety signals as a result of use of the INN “imiglucerase” for three different products that are not biosimilars: Analysis of adverse events in the Sanofi Genzyme Global Safety database

2020 ◽  
Vol 129 (2) ◽  
pp. S154
Author(s):  
So-Fai Tsang ◽  
Kristina Barakov ◽  
Cheryl Delacono ◽  
Joan Keutzer ◽  
Grace Lewis ◽  
...  
2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15037-15037
Author(s):  
S. N. Voss ◽  
A. Czarnecki

15037 Background: It is important to understand the safety profile (SP)/toxicity of new drug regimens in oncology. We compared SPs of gemcitabine (Gem) + carboplatin (Carbo) in NSCLC with Gem alone and in different combinations and also tested the methodology of drug safety profiling (DSP). Methods: Spontaneous cases for the period of 1995–2005 were reviewed on the Lilly Safety Database (LSD). DSP was used to evaluate differences in the SPs of several combinations: Gem+Carbo in NSCLC, Gem+Carbo in ovarian cancer, Gem+ cisplatin (Cis) in NSCLC, Gem+Carbo in all indications, and Gem regardless of treatment regimen, for all indications. Frequencies of adverse events (AEs) for all MedDRA System Organ Classes (SOCs) were used for each regimen. In addition, the MedDRA Preferred Terms (PTs) were reviewed to detect potential safety signals. The numbers of AEs in different SOCs were assessed as proportions of the total reports for the Gem combinations in the LSD. Results: With the exception of the Investigations SOC, the proportions of AEs for patients treated for NSCLC with Gem+Carbo were consistent with those for patients treated for NSCLC with Gem+Cis and with Gem for all indications. However, the frequency in the Investigations SOC was consistent with that reported for Gem+Carbo in all indications (14.2% v. 12.0%). A greater frequency of AEs was seen in the Gastrointestinal Disorders SOC for patients treated with Gem+Carbo for ovarian cancer compared to patients treated with Gem+Carbo for NSCLC. The review of individual PTs for Gem+Carbo did not reveal any safety signals. Conclusions: The SP of Gem+Carbo in NSCLC using DSP showed similar patterns to all other Gem combinations with only some differences due to the indication. DSP is a useful tool in assessing the new drug combination treatments in existing or new indications. [Table: see text]


Drug Safety ◽  
2012 ◽  
Vol 35 (9) ◽  
pp. 733-743 ◽  
Author(s):  
Andrew Tomlin ◽  
David Reith ◽  
Susan Dovey ◽  
Murray Tilyard

Vaccine ◽  
2008 ◽  
Vol 26 (51) ◽  
pp. 6630-6638 ◽  
Author(s):  
Thomas Verstraeten ◽  
Dominique Descamps ◽  
Marie-Pierre David ◽  
Toufik Zahaf ◽  
Karin Hardt ◽  
...  

2021 ◽  
Author(s):  
Sedigheh Khademi Habibabadi ◽  
Pari Delir Haghighi ◽  
Frada Burstein ◽  
Jim Buttery

BACKGROUND Traditional monitoring for Adverse Events Following Immunisation (AEFI) relies on various established reporting systems, where there is inevitably a lag between an AEFI occurring and its potential reporting, and subsequent processing of reports. AEFI safety signal detection strives to detect AEFI as early as possible, ideally close to real-time. Monitoring social media data holds promise as a resource for this. OBJECTIVE 1) To investigate the utility of monitoring social media for gaining early insights into vaccine safety issues, by extracting vaccine adverse event mentions (VAEM) from Twitter using natural language processing (NLP) techniques. 2) To document the NLP processes used and identify the most effective of them for successively identifying tweets that contain VAEM, with a view to defining an approach that might be applicable to other similar social media surveillance tasks. METHODS A VAEM-Mine method was developed that combines topic modelling with classification techniques to extract maximal VAEM posts from a vaccine-related Twitter stream, with a high degree of confidence. The approach does not require a targeted search for specific vaccine reactions, but instead identifies any VAEM post within many unrelated posts. RESULTS The VAEM-Mine method successively isolates vaccine adverse event mentions from the massive amount of other vaccine-related Twitter posts, achieving an F1-Score of 0.91 in the classification phase. CONCLUSIONS Social media can assist with detection of vaccine safety signals as a valuable complementary source for monitoring mentions of vaccine adverse events. A social media based VAEM data stream can be assessed for changes to detect possible emerging vaccine safety signals, helping to address the well-recognised limitations of passive reporting systems, including timeliness and under-reporting.


2021 ◽  
Vol 10 (2) ◽  
pp. 20-24
Author(s):  
Chenthamarai.G ◽  
Lakshmi Prasanna.T.

Introduction: Mirtazapine is an antidepressant drug that produces both noradrenergic and serotonergic activity. It is effective in treating of mild to severe depression. Proper evidence pointing to the safety of Mirtazapine is not established. The need for post-marketing surveillance (PMS) is considered most essential. This study was aimed to generate signal for unreported adverse drug reactions for Mirtazapine.  Materials and Methods: Our study retrospectively analyzed the AEs reported entered in the Adverse Events Reporting System (FAERS) databases in the last 10-years during the period of Jan 2011 to June 2020. Disproportionality analysis was done using Reporting Odds Ratio, Proportional Reporting Ratio, and Information Component with 95% confidence interval. Results: A disproportionality analysis was done for 41 adverse events, out of these, signal for 11 adverse events was found. ROR values 10.17 being the highest for abulia and 2.22 being the lowest for homicidal Ideation. The PRR value was 10.17 being the highest for abulia and 2.22 being the lowest for homicidal ideation. The IC025 value was 1.87 for abulia and 0.27 for homicidal Ideation. Conclusion: The present study using the Adverse Events Reporting System (FAERS) databases maintained by the FDA suggested new safety signals for Mirtazapine. Still more cohort and epidemiological studies are recommended to validate these results. Keywords: Mirtazapine, Disproportionality analysis, Safety Signals.


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