Tapentadol: navigating the complexities of abuse, patient safety & regulatory measures.

Aim: To evaluate tapentadol abuse cases by analyzing real-world data and identifying under-reporting countries from Southeast Asian Region (SEAR) to enhance vigilance.

Method: A retrospective, observational study from 2013 to March 2024 using VigiBase was conducted.

Result: Tapentadol-related abuse falls within the System Organ Class (SOC) categories of psychiatric disorder, nervous system disorder and injury, poisoning, and procedural complications.

Health-care Professionals' Perception toward Medical Device Postmarket Surveillance Practices: A Cross-sectional Study in India.

A cross-sectional, web-based survey was conducted to assess the health-care professionals (HCPs)' perception toward existing medical device postmarket surveillance (PMS) practices in India. A total of 1756 responses (medical practitioners [19.8%], nurses [22.

Neuronal toxicity of monoclonal antibodies (mAbs): an analysis of post-marketing reports from FDA Adverse Event Reporting System (FAERS) safety database.

Background: Monoclonal antibodies (mAbs) are pivotal in treating various diseases, including cancers and autoimmune disorders. Despite their therapeutic benefits, mAb therapy has been associated with neurological toxicity.

Objectives: This study aimed to assess the occurrence of neuronal toxicity associated with mAbs, utilizing data from the FDA Adverse Event Reporting System (FAERS) safety database.

Risk of pancreatitis and pancreatic carcinoma for anti-diabetic medications: findings from real-world safety data analysis and systematic review and meta-analysis of randomized controlled trials.

Background: The existing evidence from pre- and post-marketing studies is conflicting on the risk of pancreatic events for anti-diabetic medications.

Research Design And Methods: A retrospective case/non-case study was conducted by using spontaneous reports on pancreatic events for anti-diabetic medications from the FDA Adverse Event Reporting System (FAERS) and VigiBase. Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and Information Component (IC) were calculated by a disproportionality analysis.

Risk of serious skin and subcutaneous tissue disorders for nimesulide among the pediatric population: a jeopardy identified through the analysis of global individual case safety reports.

Background: The safety reports arising currently on nimesulide are divulging the jeopardy of skin and subcutaneous tissue disorders (SSTDs).

Research Design And Methods: The global individual case safety reports on nimesulide-induced SSTDs available at VigiBase® were analyzed up to 31 March 2023. Disproportionality analyses viz.

Comprehensive chemo-profiling of coumarins enriched extract derived from (L.) Correa fruit pulp, as an anti-diabetic and anti-inflammatory agent.

(L.) Correa is an Indian medicinal plant known for its vast therapeutic activities. In Ayurveda, the plant is known to balance "," "," and "" dosh.

How to improve regulatory practices for refurbished medical devices.

Modern health-care facilities rely on medical devices and equipment. However, keeping up with the development of new technology is unfeasible for many health facilities, especially in low-resource settings. Thus, the demand for refurbished medical devices is increasing worldwide, especially in low- and middle-income countries.

SGLT2 inhibitors associated pancreatitis: signal identification through disproportionality analysis of spontaneous reports and review of case reports.

Background: In recent times, pancreatitis has been one of the most frequently reported adverse events for sodium-glucose cotransporter-2 (SGLT2) inhibitors.

Aim: To evaluate the potential association between SGLT2 inhibitors and the risk of pancreatitis by analyzing the spontaneous reports through disproportionality analysis and reviewing case reports.

Method: A retrospective case/non-case study was conducted using spontaneous reports from the FDA Adverse Event Reporting System (FAERS), VigiBase, and the Canadian Adverse Reaction Database (CARD).

Public-private partnership (3Ps) in ensuring safe use of medicines: An Indian experience.

Adverse drug reactions (ADRs) are major concerns to the public health. To monitor ADRs and ensure patients' safety, the Pharmacovigilance Programme of India (PvPI) has been established by the Government of India in 2010. The programme is intact with the Public-Private Partnership (3Ps) in pharmacovigilance for quality services, better management of human resources and risk minimization.

Materiovigilance Programme of India: Current status and way forward.

Postmarketing vigilance system for medical devices in India is not as vigorous as of drugs. W Materiovigilance involves post marketing surveillance of adverse events caused by medical devices. As per directive of WHO, many countries including India have established their own post marketing surveillance system.

Comparative metabolic profiling, isolation of alkylated phenols and antioxidant activity of roots of species using GC-MS and NMR based metabolomics study.

In this study, NMR and GC-MS based comparative metabolomic profiling of the roots of three different species namely, , and were investigated followed by multivariate statistical analyses and their antioxidant activity. Also, two alkylated phenols i.e.

Comparative Study of Adverse Drug Reactions Associated with Filgrastim and Pegfilgrastim Using the EudraVigilance Database.

The primary prophylaxis with filgrastim (FIL) and pegfilgrastim (PEG-F) is recommended to decrease the severity of chemotherapy-induced neutropenia (CIN). The commonly reported adverse drug reactions (ADRs) with FIL and PEG-F is bone pain. ADRs pertaining to FIL and PEG-F were extracted from the European EudraVigilance (EV) database.

Acute intraocular toxicity caused by perfluorocarbon liquids: safety control systems of medical devices.

Background: Acute retinal toxicity has been demonstrated to be associated with the intraoperative use of perfluorocarbon liquids (PFCLs), especially perfluorooctane (PFO). Recently, several cases of PFO-associated blindness have been reported in Spain, Holland, France, Italy, the Middle East, and South America.

Methods: As a result, a new ISO guideline (ISO 16672:2020) was drafted, discussed, approved, and released in 2019.

Analysis of severity and preventability in patients of-Toxic epidermal necrolysis-A case series.

SJS-TEN is life-threatening autoimmune disorder triggered due to drugs such as analgesics, antibiotics, anticonvulsants, and antipsychotics. This report provides awareness to the Clinicians regarding prescription of drugs which cause SJS-TEN. Among young females of 20-40 years, screening for previous history, issuing drug alert cards, and preventing OTC prescriptions decreases mortality.

Ajmalicine and Reserpine: Indole Alkaloids as Multi-Target Directed Ligands Towards Factors Implicated in Alzheimer's Disease.

Alzheimer's disease (AD) is a multifactorial disorder characterized by exponential loss of memory and cognitive deficit involving several disease modifying targets (amyloid beta, beta-secretase, monoaminoxidase-B, and cholinesterase). The present study explores multi-target directed ligand approach using secondary metabolite reserpine (RES) and ajmalicine (AJM) obtained from roots. Novel LCMS and HPLC methods were developed for identification and quantification of reserpine and ajmalicine.

Towards a comprehensive safety understanding of granulocyte-colony stimulating factor biosimilars in treating chemotherapy associated febrile neutropenia: Trends from decades of data.

Filgrastim, a biopharmaceutical listed on WHO model list of essential medicines, was approved in USA in 1991 for patients with non-myeloid malignancies associated with severe neutropenia and fever. Several filgrastim biosimilars have now been approved in USA, Europe and elsewhere since 2008, based on the reference product which has lost patent exclusivity; however their immunogenicity and safety is controversial. We conducted a retrospective, post market study between 1991 and May 2018 using VigiBase®.

Implementation of adverse event reporting for medical devices, India.

Problem: Rapid growth in the use of medical devices has drawn attention to gaps in the systematic monitoring of medical device-associated adverse events in India.

Approach: Implementation of national regulations on medical devices started in January 2018. Supported by a nationwide network of monitoring centres, the Indian Pharmacopoeia Commission coordinates adverse event reports from manufacturers, legal representatives and patients or users.

"ADR PvPI" Android mobile app: Report adverse drug reaction at any time anywhere in India.

Background: To improve the public health and promote instant adverse drug reaction (ADR) reporting, a need to develop an ADR Pharmacovigilance Programme of India (PvPI) mobile app was identified by the National Coordination CentrePvPI (NCCPvPI) to serve the Pan India ADR reporting. The objective of this study was to develop an indigenous Googlebased Android mobile application known as "ADR PvPI" and to analyze the ADRrelated data reported through this mobile application on pilot basis.

Materials And Methods: The ADR PvPI mobile application was indigenously developed by NCCPvPI officials within 6 months.

Pivotal role of Pharmacovigilance Programme of India in containment of antimicrobial resistance in India.

Misuse of antimicrobials has become one of the grave concerns of public health. In last two decades, this has been largely contributing in the emergence of antimicrobial resistance (AMR) among all the pathogens. A 2013 report of Centres for Disease Control and Prevention, USA figured that at least 2 million people get an antibiotic-resistant infection every year and as many as 23,000 people lost their life.

Cefixime-associated acute generalized exanthematous pustulosis: Rare cases in India.

Background: Cefixime is a widely used third-generation cephalosporin schedule H1 drug, which is prescribed for the treatment of otitis media, respiratory tract infections, and uncomplicated urinary tract infections and is effective against infections caused by and species in India. The National Coordination Centre (NCC)-Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC), has received rare individual case safety reports (ICSRs) for acute generalized exanthematous pustulosis (AGEP) associated with the use of cefixime.

Materials And Methods: IPC, NCC-PvPI also acts as a national collaborating center for pharmacovigilance activities under the aegis of Ministry of Health and Family Welfare, Government of India; moreover, it is a member country in global pharmacovigilance system, World Health Organization-Uppsala Monitoring Centre, Sweden.

Safety monitoring of local anaesthetic drugs from the perspective of Pharmacovigilance Programme of India.

Pharmacovigilance Programme of India (PvPI) was established to promote patient safety by the Ministry of Health and Family Welfare, Government of India in July 2010. It covers various medical hospitals/institutes and National Health Programmes across the country. India is coordinating with various national and international programmes to be a part of international drug monitoring and to monitor the risk-benefit profile of medicines.