Background: 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. Methods: 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. Results: 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 ( P = .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 ( P = .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 ( P = .914, Z = −0.108). Conclusion: 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.
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.
Background: Teeth whitening or dental bleaching is a procedure that is most often asked by patients because it is a very effective way to improve the appearance and aesthetics of a smile when compared with other invasive restorative treatments. Strawberry being a natural ingredient helps in the teeth whitening process. Aim: The aim of the study is to find the effect of strawberry extract on tooth discoloration and morphology Materials and Methods: Non- carious tooth samples were used for the experiment. Mandibular premolars were used as the samples, in which one tooth was immersed in strawberry extract and the other was in distilling water and kept for three days. The height and size of the tooth were measured to determine morphological changes before and after experiments. The results were compared between the dimensions of both the teeth for 72 hours and plotted into a bar graph. Results: The results indicated that there were no significant morphological changes between the tooth immersed in strawberry extract and distilled water. Conclusion: Fruits and leaves of strawberry plants are used to whiten teeth. Chewing strawberries every day can help to nourish the mouth, such as whitening of teeth and making breath more fresher. All these processes take place only if teeth are exposed to strawberry for a long period. Our study established the teeth whitening and anti-decay properties of strawberry extract in the teeth. Further research is required to observe the effect of strawberry extract on teeth in detail.
Aim: The aim of the present study is to create awareness among Dentists treating HIV patients. Introduction: Healthcare workers including physicians, dentists, nurses and laboratory workers are considered to be among the groups at the risk of blood-borne pathogen transmission. Dental treatment procedures frequently involve exposure to blood and saliva that may be contaminated with HIV. Dental care of HIV-positive individuals plays a vital role in improving their nutritional intake, medication tolerance and effectives, treatment success rate, and quality of life. The main motive of the present study was to assess the knowledge, attitude and practice towards HIV patients among dentists. Materials and Methods: A descriptive cross-sectional study survey was conducted among 101 dentists practicing in and around the area. It was done as an online survey. The data was collected using pre-tested self administrated 11 item questionnaire and was statistically analyzed using SPSS software version-23. Results: The results show that the majority of the subjects in the study population were males (55%) and remaining were females (44%).There were no significant differences between males and females in the knowledge and attitude scores. Conclusion: The results of the survey demonstrated a satisfactory level of knowledge and attitude of dentists about HIV/AIDS infections but some general population suggesting that higher knowledge level of dentists plays a very important role in forming the attitude and practices regarding patients with HIV/AIDS.
Purpose/Background The study aims to assess whether the early response can predict the outcome at the endpoint for the treatment of first-episode psychosis with risperidone and identify the relationship between initial symptom reduction and late response. Methods/Procedures A prospective observational study with 4 points follow-up (weeks 2, 3, 4, and 8) was conducted in 48 adult first-episode psychosis patients. Symptoms were quantified by the Positive and Negative Syndrome Scale (PANSS) score. The initial recommended dose was 2 mg of risperidone once daily before sleep. The PANSS score on day 1 (before initiation of drug therapy) was considered as the baseline score. Treatment responses were considered as a reduction of more than 20%, 25%, 30% and 50% from the baseline score on first, second, third, and final follow-up, respectively. Receiver operating characteristic curves were generated for predicting response at the endpoint. Findings/Results Thirty-one (65%) patients achieved more than 50% reduction (responders) in PANSS score. The mean total PANSS score of the study population after 8 weeks of therapy was found to be 49.77 (95% confidence interval, 46.10–53.43). The mean percentage reduction in PANSS score after 8 weeks of therapy was found to be 52.92% (95% confidence interval, 48.83–57.01). Week 2 response can be taken as the early response (area under the curve = 81.9, P < 0.001). However, the more accurate prediction was possible with week 4 response (area under the curve = 88.7%, P < 0.001). Implications/Conclusions Our study suggests that patients with an early response at week 2 are likely to achieve positive response after 8 weeks.
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