Publications by authors named "Elsa Beulah"

5 Publications

  • Page 1 of 1

Existence of Notoriety Bias in FDA Adverse Event Reporting System Database and Its Impact on Signal Strength.

Hosp Pharm 2021 Jun 18;56(3):152-158. Epub 2019 Oct 18.

Department of Pharmacy Practice, M. S. Ramaiah University of Applied Sciences, Bengaluru, India.

Notoriety bias is defined as "a selection bias in which a case has a greater chance of being reported if the subject is exposed to the studied factor known to cause, thought to cause, or likely to cause the event of interest." This study aimed to determine the existence of notoriety bias in the FDA Adverse Event Reporting System (FAERS) database and estimate the impact of potential notoriety bias induced by safety alerts on signal estimation using disproportionality analysis. Publicly available FAERS data were downloaded and used for analysis. Thirty-one drugs which had label change/safety alert issued by FDA from 2009 to 2013 were considered. These drugs were reviewed 4 quarters before and after the safety alert notification for the existence of notoriety bias. The impact of notoriety bias induced by safety alerts was analyzed by comparing the signal strength using reporting odds ratio (ROR) and proportional reporting ratio (PRR), 2 years before and after the safety alert. Wilcoxon signed rank test was used to determine whether there were a statistically significant difference before and after the safety alert. There was increased reporting for 11 drugs after the safety alert/label change by the FDA. The reporting of 20 drugs decreased or remained unchanged after the safety alert/label change by the FDA. Wilcoxon signed rank test showed that there is no statistically significant difference with respect to the number of reports before and after the safety alert ( = .330, Z = -0.974). Fourteen (45.16%) drugs had an increase in ROR, while 17 (54.83%) drugs had a decrease in ROR after safety alert issued by FDA ( = .953, Z = -0.059). Fourteen (45.16%) drugs had an increase in PRR, while 17 (54.83%) drugs had a decrease in PRR after safety alert issued by the FDA ( = .914, Z = -0.108). Although few FDA safety alert/warnings had a strong and immediate impact, many had no impact on reporting of AE and signal strength. This study found that overreporting due to notoriety bias does not exist in the FAERS database and the overall disproportionality in signal estimates is not altered by the safety alert.
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http://dx.doi.org/10.1177/0018578719882323DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114300PMC
June 2021

Vemurafenib Induced Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): A Disproportionality Analysis in FAERS Database.

Curr Clin Pharmacol 2020 Jun 28. Epub 2020 Jun 28.

Department of Pharmacy Practice, Faculty of Pharmacy, M S Ramaiah University of Applied Sciences, Bengaluru. India.

Background: Signal strength for any drug event combination can be determined using disproportionality analysis. Vemurafenib is a BRAF inhibitor approved by the US Food and Drug Administration (FDA) in 2011 for the treatment of metastatic melanoma. This study aims to identify the signal strength of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) associated with vemurafenib using disproportionality analysis in FDA database of Adverse Event Reporting System (FAERS).

Methods: Data were obtained from the public release of data in FAERS. Case/non-case method was adopted for the analysis of association between vemurafenib use and DRESS. The data mining algorithm used for the analysis was Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). A value of ROR-1.96SE>1, PRR≥2 were considered as positive signal strength.

Results: A total of 7,171 reports for DRESS have been reported in the FDA database. Amongst which 125 reports were associated with vemurafenib. A cumulative ROR of 17.72 (95% CI 14.83; 21.18) and PRR of 17.46 (95% CI 14.65; 20.81) were observed. Combination treatment of vemurafenib with cobimetinib had higher number of reports (100) with ROR of 103.42 (84.13- 127.14) and PRR of 94.52 (78.26- 114.15). Four deaths were reported and the non-death serious reports included hospitalization, life-threatening, disability, and other serious events with 61, 11, 2 and 39 reports respectively.

Conclusion: Positive signal strength was observed for vemurafenib associated DRESS. The signal strength was higher for vemurafenib in combination with cobimetinib than vemurafenib alone. Health care professionals should be cautious about encountering serious adverse events and should be reported to the regulatory authorities.
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http://dx.doi.org/10.2174/1574884715666200628113508DOI Listing
June 2020

Aromatase inhibitors associated osteonecrosis of jaw: signal refining to identify pseudo safety signals.

Int J Clin Pharm 2020 Apr 8;42(2):721-727. Epub 2020 Apr 8.

Department of Pharmacy Practice, Faculty of Pharmacy, M S Ramaiah University of Applied Sciences, New BEL Road, Bengaluru, 560054, Karnataka, India.

Background Signal generation through data mining algorithms is an innovative and emerging field in pharmacovigilance. Early detection of safety signals is important for public health safety. However, the possibility of generating pseudo signals should not be overlooked. Objective Our study aimed to identify potential signals of aromatase inhibitors associated Osteonecrosis of Jaw and assess the possibilities of the safety signal to be a pseudo signal/false positive in FDA Adverse Event Reporting System (FAERS). Setting Spontaneously reported data in FAERS database. Methods Data for this study were obtained from the public release of data in FAERS. OpenVigil, a pharmacovigilance analytical tool was used to access FAERS data. Reporting Odds Ratio (ROR) was used to assess the relation between the drug and adverse event. A value of ROR-1.96SE  > 1, (SE-standard error) was considered positive. Main outcome measure Signal strength. Results FAERS database had a total of 15,178 reports for Osteonecrosis of Jaw. Amongst which 617 reports were associated with aromatase inhibitors. Signal strength ROR (lower bound of the 95% CI) for letrozole, anastrozole and exemestane associated Osteonecrosis of Jaw without any background correction was 8.34, 6.64 and 15.14 respectively. Upon removing the reports of concomitantly administered drugs (bisphosphonates and denosumab), signal strength drastically decreased to 0.03, 0.36 and 0.47 for letrozole, anastrozole and exemestane respectively. The signal strength of bisphosphonates and denosumab associated Osteonecrosis of Jaw was not changed significantly upon removal of aromatase inhibitors. Conclusion Our study concluded that the signal generated for aromatase inhibitors associated Osteonecrosis of Jaw in FAERS database can be false positive. Careful background corrections with identification of those risk factors are imperative to exclude false positive results.
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http://dx.doi.org/10.1007/s11096-020-01018-zDOI Listing
April 2020

Postlicensure surveillance of human papillomavirus vaccine using the Vaccine Adverse Event Reporting System, 2006-2017.

Perspect Clin Res 2020 Jan-Mar;11(1):24-30. Epub 2019 Apr 26.

Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, Bangalore, India.

Background: The United States Food and Drug Administration (FDA) has licensed three HPV (Human papilloma virus) vaccines. The centers for disease control and prevention (CDC) and advisory committee on immunization practices (ACIP) recommends routine HPV vaccination at age 11 or 12 years. This study aimed to summarize and characterize adverse events following HPV vaccination reported to VAERS database from July 2006 to May 2017.

Methods: A systematic data mining was performed in the VAERS database for reports associated with HPV vaccine. Clinically relevant Vaccine Event Combinations (VEC) were identified in the VAERS database following HPV vaccination. A VEC was considered for analysis only if a minimum of hundred reports were present in database for the given Adverse Event (AE). The data mining algorithm used in this study was reporting odds ratio. A value of ROR-1.96SE >1 was considered as positive signal.

Results: VAERS received 49444 reports after receipt of HPV vaccine during the study period. Out of 49444, 2307 unique reactions were identified. A total of 177 death reports and 3526 non death serious reactions were reported to VAERS. ROR showed positive signals for abdominal pain, syncope, dizziness, convulsion, abortion spontaneous, alopecia, amenorrhea, anogenital warts, cervical dysplasia, anaemia, dyskinesia, migrane, blood pressure decreased, fall, head injury, loss of consciousness, pallor, presyncope, seizures.

Conclusion: The present analysis did not identify any new/unexpected safety concern and was consistent with the safety data from prelicensure trials. Further epidemiological studies are required to systematically validate the data provided by VAERS.
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http://dx.doi.org/10.4103/picr.PICR_140_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7034135PMC
April 2019

Novel adverse events of vortioxetine: A disproportionality analysis in USFDA adverse event reporting system database.

Asian J Psychiatr 2017 Dec 14;30:152-156. Epub 2017 Sep 14.

Department of Pharmacy Practice, Faculty of Pharmacy, M S Ramaiah University of Applied Sciences, Bengaluru, India.

Background: Signal detection is one of the most advanced and emerging field in pharmacovigilance. It is a modern method of detecting new reaction (which can be desired or undesired) of a drug. It facilitates early adverse drug reaction detection which enables health professionals to identify adverse events that may not have been identified in pre-marketing clinical trials. Vortioxetine, the first mixed serotonergic antidepressant was initially approved by the US Food and Drug Administration (USFDA) on September 30, 2013 for the treatment of adults with Major Depressive Disorder (MDD). This study was to identify the signal strength for vortioxetine associated ADRs using data mining technique in USFDA Adverse Event Reporting System (AERS) database.

Methodology: Most commonly used three data mining algorithms, Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR) and Information Component (IC) were selected for the study and they were applied retrospectively in USFDA AERS database from 2015Q1 to 2016Q3. A value of ROR-1.96SE >1, PRR≥2, IC- 2SD>0 were considered as the positive signal.

Result: A study population of 61,22,000 were reported all over the world. Among which 3481 reactions were associated with vortioxetine which comprised of 632 unique events encompassed with 27 clinically relevant reactions. ROR, PRR and IC showed positive signal for weight loss, agitation, anger, ketoacidosis, insomnia and abnormal dreams.

Conclusion: The present study suggests that vortioxetine may result in these adverse events. Further pharmacoepidemiologic studies are necessary to confirm this conclusion and to improve the precision of the prevalence and/or the risk factors of this ADRs.
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http://dx.doi.org/10.1016/j.ajp.2017.09.005DOI Listing
December 2017