Journal of Pharmacovigilance & Drug Safety

Exploring the safety of combination therapy with SGLT-2 and DPP-4 inhibitors in type 2 Diabetes mellitus

2024-06-29T11:03:21+00:00

Type 2 diabetes mellitus (T2DM) presents a complex pathogenesis involving various mechanisms, necessitating multiple therapeutic approaches for effective glycemic control. While metformin remains the first-line therapy, additional agents are often required to maintain optimal glucose levels. The combinatory use of anti-diabetic agents with complementary mechanisms of action, such as sodium-glucose co-transporter 2 (SGLT2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors, has emerged as a promising strategy. This review explores the safety profile of different combinations of SGLT2 inhibitors and DPP4 inhibitors. SGLT2 inhibitors offer glucose-lowering effects with potential cardiovascular benefits but come with considerations such as the risk of hypoglycemia, urinary tract and genital infections, diabetic ketoacidosis, and fractures and amputations. Conversely, DPP-4 inhibitors provide effective glycemic control with a low risk of hypoglycemia, although concerns exist regarding infections, hypersensitivity reactions, pancreatitis, and cardiovascular safety. Evaluating combination therapies, including Empagliflozin + Linagliptin, Canagliflozin + Teneligliptin, Dapagliflozin + Saxagliptin, and Dapagliflozin + Sitagliptin, reveals a generally favorable safety profile, with manageable risks consistent with individual component therapies. Notably, these combinations mitigate the risk of hypoglycemia while offering efficacy in glycemic control. Further research and monitoring are warranted to fully elucidate the long-term safety and efficacy of these combination therapies in managing T2DM.

Biopharmaceuticals Breakthroughs and Beyond: Understanding and Mitigating Adverse Drug Reactions (ADRs)

2024-06-29T11:08:22+00:00

Biopharmaceuticals, while revolutionizing medicine, harbor potential for adverse reactions (ADRs)1,2,3. This presentation seeks to offer an exploration of adverse reactions (ADRs) linked to biopharmaceuticals. It will address the current scenario, emerging challenges, and essential pharmacovigilance strategies to enhance the safety of biopharmaceutical therapy.
Material :
This article is based on a comprehensive review of scientific literature published between 2017 and 2024. Relevant articles were identified in PubMed and Google Scholar using the keywords "biopharmaceuticals," "adverse reactions," "pharmacovigilance," and related terms. In addition to research papers, we reviewed case studies and reports from the World Health Organization (WHO) and the US Food and Drug Administration (FDA).
Methods :
This is a narrative review aimed at providing a comprehensive overview of the current understanding of ADRs associated with biopharmaceuticals. We critically assessed the identified literature, analyzed trends and patterns in ADR reporting, and incorporated case studies to illustrate the challenges and complexities involved.

Navigating the Landscape of Medical Device Failures: Challenges, Regulations, and Materiovigilance

2024-06-29T11:13:03+00:00

Introduction: In the realm of healthcare, the significance of materiovigilance cannot be overstated. Materiovigilance, a term often overshadowed by pharmacovigilance, focuses on the surveillance and control of medical devices' safety and performance post-marketing. Its components include the systematic collection, analysis, and interpretation of data related to medical devices, aiming to enhance patient safety by decreasing adverse events associated and optimize device efficacy
Methodology: This literature review utilized databases like PUBMED, EMBASE, SCOPUS, and COCHRANE, employing keywords such as "materiovigilance"; "pharmacovigilance" ;"materiovigilance history"; and "awareness about materiovigilance"
Results: Critical components like vigilance reporting systems, risk assessment, and regulatory interventions play a pivotal role in ensuring medical device safety. It is evident that a significant lack of awareness, posing risks to patient safety. This research serves as a tool to bridge the awareness gap, emphasizing the need for understanding and active participation in Materiovigilance
Conclusion: Collaborative efforts among regulatory bodies, healthcare providers, and manufacturers can enhance understanding and awareness in Materiovigilance. This clarity and collaboration contribute to fostering Materiovigilance awareness, ensuring improved patient safety. By creating awareness, we aim to establish a safer healthcare environment, guaranteeing the efficacy and safety of medical devices globally.

A Case Report on Paracetamol-Induced Perorbital Edema

2024-06-29T11:17:55+00:00

Background: Paracetamol is a one of the commonly used over-the-counter analgesic & antipyretic drug. Paracetamol hypersensitivity can vary from immediate Type I hypersensitivity reactions such as angioedema, urticaria and anaphylaxis, which are probably immunoglobulin E (IgE)-mediated, to delayed Type IV reactions such as fixed-drug eruptions, stevens–Johnson syndrome, baboon syndrome & toxic epidermal necrolysis.
Case Report: This is a case of 28 years old female, with no known allergies or pre-existing medical conditions, came to dermatology OPD with acute onset of swelling around the eyes & itching all over the body shortly after consuming paracetamol 650mg for fever. No other medication was taken. Next day, she consulted in dermatology OPD. On examination, vital parameters were stable. Periorbital edema & rashes over the entire body were present. Proper treatment was given to the patient.
Discussion: Paracetamol hypersensitivity is mostly diagnosed based on the patient's clinical history. Hypersensitivity reactions to paracetamol are most commonly mediated through the pharmacological action of COX-1 inhibition but may also be paracetamol-specific IgE or T cells mediated.
Conclusion: Since paracetamol allergic reactions are rare, these could go unnoticed as the reason for sudden hypersensitivity, which might cause a delay in diagnosis.

International Conference on Safety of Medicines & 21st Annual Conference of Society of Pharmacovigilance India

2024-06-29T11:36:24+00:00

In the ever-evolving landscape of healthcare, where the tapestry of medications expands with each passing year, ensuring the safety of these interventions remains paramount. This fundamental principle forms the bedrock of pharmacovigilance, a multifaceted discipline dedicated to the detection, assessment, understanding, and prevention of adverse effects associated with pharmaceutical products. With the growing prominence of modern medicines alongside the resurgence of alternative therapies, the field of pharmacovigilance faces an ever-increasing challenge: safeguarding patient well-being in the face of diverse pharmacological landscapes.