Publications by authors named "Nair Gouri"

3 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

Repression of Polyol Pathway Activity by Hemidesmus indicus var. pubescens R.Br. Linn Root Extract, an Aldose Reductase Inhibitor: An In Silico and Ex Vivo Study.

Nat Prod Bioprospect 2021 Jun 7;11(3):315-324. Epub 2020 Dec 7.

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

Development of diabetic cataract is mainly associated with the accumulation of sorbitol via the polyol pathway through the action of Aldose reductase (AR). Hence, AR inhibitors are considered as potential agents in the management of diabetic cataract. This study explored the AR inhibition potential of Hemidesmus indicus var. pubescens root extract by in silico and ex vivo methods. Molecular docking studies (Auto Dock tool) between β-sitosterol, hemidesminine, hemidesmin-1, hemidesmin-2, and AR showed that β-sitosterol (- 10.2 kcal/mol) and hemidesmin-2 (- 8.07 kcal/mol) had the strongest affinity to AR enzyme. Ex vivo studies were performed by incubating isolated goat lenses in artificial aqueous humor using galactose (55 mM) as cataract inducing agent at room temperature (pH 7.8) for 72 h. After treatment with Vitamin E acetate - 100 µg/mL (standard) and test extract (500 and 1000 µg/mL) separately, the estimation of biochemical markers showed inhibition of lens AR activity and decreased sorbitol levels. Additionally, extract also normalized the levels of antioxidant markers like SOD, CAT, GSH. Our results showed evidence that H. indicus var. pubescens root was able to prevent cataract by prevention of opacification and formation of polyols that underlines its potential as a possible therapeutic agent against diabetic complications.
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http://dx.doi.org/10.1007/s13659-020-00290-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8141070PMC
June 2021

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