A Longitudinal Analysis of Black Box Warnings: Trends and Implications for Drug Safety.

A black box warning, signaling potential life-threatening adverse effects of medications or medical devices, is crucial for public and healthcare professional awareness. Comprehending and adhering to these warnings can prevent serious harm. This review aims to elucidate their significance. Data on drugs with black box warnings were collected from the Food and Drug Administration's (FDA's) official website using the search term 'Boxed warnings' from January 1, 2015, to January 31, 2024. A Microsoft Excel spreadsheet (Microsoft Corporation, Redmond, WA, USA) containing black box warnings for this period was downloaded from the FDA's website. Additional parameters, such as drug class and whether the warnings were new or existing, were added to the downloaded spreadsheet. The collected data were organized by year, categorizing new and existing warnings, along with details on the evidence source, system-wise classification, and black box warnings for commonly used drugs, including their clinical significance. Results show that in the past decade, 40% of black box warnings were issued in 2023, followed by 12% in 2022. Most warnings (67%) comprised existing ones with minor revisions while 29% were new. Nine existing warnings were removed during the period. Post-marketing studies predominantly provided evidence for these warnings. Neuropsychiatric concerns like addiction potential (31%), suicidal tendency (7%), and hypersensitivity reactions (12%) were the frequently encountered black box warnings. Black box warnings play a crucial role in highlighting the serious adverse effects of medications. Neuropsychiatric warnings have been frequent over the past decade. Awareness of these warnings is essential to prevent adverse effects and enhance patient care, especially concerning drugs like guaifenesin/hydrocodone bitartrate, zolpidem, and montelukast commonly encountered in clinical practice.

Prevalence of Amblyogenic Risk Factors Among School Children in India Using the Spot Vision Screener.

INTRODUCTION: Amblyopia is a common cause of preventable visual impairment in children, affecting 1% to 6% globally. This study assesses amblyopia prevalence and risk factors among school children in rural Telangana, India, using the Spot Vision Screener (Welch Allyn, Inc., Skaneateles Falls, New York, USA), a portable, noninvasive device recommended for automated vision screening. METHODS: A cross-sectional study was conducted on 714 schoolchildren aged 5-10 years. Screening was performed using the Spot Vision Screener, evaluating refractive errors, ocular alignment, and other amblyopia risk factors. Children identified with potential amblyogenic factors were referred for comprehensive ophthalmological evaluation to confirm diagnosis. RESULTS: Out of 714 children screened, 84 were referred by the Spot Vision Screener for further evaluation. Subsequent examination by ophthalmologists confirmed amblyopia in 65 children, resulting in a prevalence of 9.10%. Myopic refractive error was the most prevalent (69.23%), followed by astigmatism (21.53%) and hypermetropia (9.23%) among amblyopia cases. CONCLUSION: The Spot Vision Screener proved to be a reliable tool for identifying amblyopia risk factors in school children, facilitating early detection and referral for appropriate management. This study underscores the importance of implementing effective vision screening programs in rural settings to mitigate preventable childhood blindness.

Correlation of Serum Electrolyte Imbalances With Diabetic Duration and Medication Use: A Cross-Sectional Comparative Study.

BACKGROUND: Certain anti-diabetic medications may exacerbate electrolyte imbalances, potentially complicating glycemic control in diabetic patients. The present study aimed to correlate the serum electrolyte imbalances such as Na+, K+, Ca+2, Cl-, and Mg+2 with the duration of disease, glycemic control, and medication regimens. METHOD: In this cross-sectional study, 31 patients with type 2 diabetes mellitus (T2DM) and 30 healthy controls, with mean ages of 52.06 and 48.5 years, respectively, were recruited based on eligibility criteria. Data on demographic information, medication history, and duration of diabetes were collected. Fasting blood sugar (FBS), postprandial blood sugar (PPBS), glycated hemoglobin (HbA1C), and serum electrolytes were measured. The data were statistically analyzed. The mean differences in serum electrolytes between T2DM patients and non-diabetic participants were compared using the Mann-Whitney U test, and correlation analysis was performed. A p-value of <0.05 was considered statistically significant. RESULT: Around 9.6% of participants had diabetes duration of less than one year, while the majority (45%) fell within the 1-5-year duration range. Most diabetic patients (61.2%) exhibited poor glycemic control. Statistically significant differences were observed between the mean FBS, PPBS, and HbA1C levels of T2DM (150, 249, and 8.82, respectively) and control group (95, 114, and 5.52, respectively). Analysis of serum electrolytes showed statistically significant differences with regard to Na+, K+, and Cl- between the diabetic and control groups. Mean sodium and chloride levels were lower and potassium levels were higher in diabetic patients compared to the control group. Negative correlations were observed between sodium and chloride levels and duration of diabetes and HbA1C levels. CONCLUSION: The study reveals significant electrolyte imbalances in patients with T2DM, characterized by reduced sodium and chloride levels and elevated potassium levels compared to healthy controls. These alterations are closely associated with poor glycemic control and longer disease duration, emphasizing the importance of regular electrolyte monitoring in T2DM management to mitigate potential complications.

A Comparative Analysis of Low-Density Lipoprotein Cholesterol (LDL-C)-Lowering Activities of Bempedoic Acid, Inclisiran, and PCSK9 Inhibitors: A Systematic Review.

Newer drugs, such as bempedoic acid, inclisiran, alirocumab, and evolocumab have recently been introduced for dyslipidemia. This systematic review aims to perform a comparative analysis of these drugs' low-density lipoprotein cholesterol (LDL-C)-lowering activities. The PubMed database was utilized to search for randomized controlled trials. Articles were screened and selected based on specific inclusion and exclusion criteria. The primary outcome of this review is to compare the percentage reduction of LDL-C and apolipoprotein-B, along with the number of reported serious adverse events (SAEs) in trials specific to each drug. A total of 14 studies were included, four for bempedoic acid and alirocumab and three for evolocumab and inclisiran. The maximum percentage reduction in LDL-C and apolipoprotein-B from baseline to 12 weeks was observed with alirocumab, administered at 150 mg subcutaneously twice weekly for 12 weeks, achieving reductions of 72.4% and 57.9%, respectively. Lesser reductions were observed with bempedoic acid, administered at 180 mg once daily orally for 12 weeks. The highest number of SAEs were reported with bempedoic acid (216, 10%) and inclisiran (181, 11%; 175, 11%). This systematic review showed that alirocumab achieved the greatest reductions in LDL-C and apolipoprotein-B and a better safety profile. Newer LDL-C-lowering drugs show promise in improving lipid profiles, patient compliance, and safety. However, these findings are not conclusive, as other factors also influence treatment choice.

Efficacy and Safety of Anti-SARS-CoV-2 Monoclonal Antibodies: An Updated Review.

Monoclonal antibodies (mAbs) had received emergency use authorization for mild-to-moderate coronavirus disease 2019 (COVID-19) or for prophylaxis against COVID-19, including casirivimab plus imdevimab (C+I), bamlanivimab plus etesevimab (B+E), tixagevimab plus cilgavimab (T+CG), and sotrovimab (S) and bebtelovimab (BEB). This systematic review was done to assess the efficacy and safety of the same. PubMed, Embase, Scopus, medRxiv, bioRxiv, and FDA fact sheets were searched for the studies published between January 2021 and May 2022, and appropriate search terms related to the mentioned mAbs were used for data collection. Review included original research including randomized clinical trials and observational studies published or preprints. Studies included in the review had compared with placebo or standard of care or no treatment or mAbs with each other and also of various doses. Data extraction was done and reviewed the same for both efficacy and safety. Total of 20 studies were included in this review. The rate of hospitalization within 30 days showed ∼2% in comparison to ∼7% with placebo. Significant reduction in viral load was more observed with combination mAbs. Combination therapy showed faster virological cure against the Gamma variant. With C + I as postexposure prophylaxis (PEP), 29.0% of asymptomatic participants developed symptomatic COVID-19. Pre-exposure prophylaxis with T+CG reduced the incidence of infection by 77%. Infusion-related reaction was the most common adverse event (AE). The neutralizing mAbs reduced hospitalization in mild-to-moderate patients with infusion-related reactions as common AE. The response was better in the seronegative patients. Most of these studies were conducted in unvaccinated individuals and against Alpha, Gamma, and Delta variants.

Efficacy and safety of Molnupiravir in COVID-19 patients: a systematic review.

BACKGROUND: Molnupiravir is an oral antiviral drug that received Emergency Use Authorization in three countries for the treatment of mild COVID-19. The aim of this systematic review was to find out the safety and efficacy of Molnupiravir in SARS-COV-2 infections. METHODS: The electronic databases such as PubMed, MedRxiv, BioRxiv, FDA, ClinicalTrials.Gov, ctri.nic.in and Google Scholar were searched for articles from January 2021 to March 2022 using the keywords such as "Molnupiravir", "COVID-19", "Oral antiviral pill", "MK-4482", "EIDD-280", "Efficacy" and "Safety". Details of published, unpublished with interim reports and ongoing studies of Molnupiravir in COVID-19 were retrieved, and a systematic review was performed. RESULTS: A total of 6 articles and 18 ongoing trials data were collected. Out of these, data from 4 published and 2 unpublished with interim reports were extracted. After review of these studies, it was observed that the daily dose of 1600 mg Molnupiravir for 5 days was safe and tolerable with nausea, diarrhea and headache as the common adverse effects. The results also showed significant decrease in time to viral clearance with 800 mg twice daily in mild patients and reduction in the risk of hospitalization or death by 50% in non-hospitalized COVID-19 patients. CONCLUSION: Evidence from clinical studies showed that Molnupiravir caused significant reduction in the risk of hospitalization or death in high-risk mild COVID-19 patients. Molnupiravir was also found to be well tolerated and safe without any major adverse events on short-term use. For confirmative use of this drug in mild-to-moderate COVID-19 disease, further studies are required in vaccinated COVID-19 patients and against emerging variants.

Face Mask in COVID-19 and Its Association With Dry Eye Disease: A Cross-Sectional Study.

AIM: To determine whether wearing a face mask for more than three to six hours/day leads to the new onset of symptoms or worsening of pre-existing dry eye disease (DED) in healthcare workers (HCWs) of our institute. METHODOLOGY: An observational cross-sectional study, where 114 HCWs using face masks regularly participated voluntarily in the study. A survey with a modified Ocular Surface Disease Index (OSDI) questionnaire was completed by participants. They were divided into groups based on their sex, age, how long they had been wearing face masks, and whether they had a history of DED. RESULTS: We found that for HCWs who had previously experienced DED and who were under the age of 40, wearing a face mask for more than three to six hours/day could contribute to or worsen symptoms of DED. Also, we observed that the N-95 mask has a higher chance of causing DED than surgical masks. CONCLUSION: Medical professionals need to be aware of any potential dry eye symptoms related to the prolonged use of a face mask. Additional consideration should be given to patients who already have DED. The possible concerns that incorrectly fitted facemasks may cause to the health of their ocular surface should be discussed with patients by ophthalmologists. Future research involving larger populations will shed light on the prevalence and scope of the mask-associated dry eye problem.

Everything real about unreal artificial intelligence in diabetic retinopathy and in ocular pathologies.

Artificial Intelligence is a multidisciplinary field with the aim of building platforms that can make machines act, perceive, reason intelligently and whose goal is to automate activities that presently require human intelligence. From the cornea to the retina, artificial intelligence (AI) is expected to help ophthalmologists diagnose and treat ocular diseases. In ophthalmology, computerized analytics are being viewed as efficient and more objective ways to interpret the series of images and come to a conclusion. AI can be used to diagnose and grade diabetic retinopathy, glaucoma, age-related macular degeneration, cataracts, IOL power calculation, retinopathy of prematurity and keratoconus. This review article intends to discuss various aspects of artificial intelligence in ophthalmology.