PVigilant Health

PVigilant Health PVigilant Health was established to provide support, solutions and consultations on Pharmacovigilance

ANNOUNCEMENT: The path to a verified PV career is opening!🔔 If you're looking for the fastest way to gain practical skil...
28/09/2025

ANNOUNCEMENT: The path to a verified PV career is opening!

🔔 If you're looking for the fastest way to gain practical skills and a recognized credential in Pharmacovigilance, pay attention.

The next wave of our Fundamentals Course is officially set for November, 2025. ​
This is your chance to learn directly from a 29-year veteran and receive a prestigious CPD-accredited certificate from the British Accreditation Body.

Seats are limited!
Book your seat NOW 🏃‍♀️🏃‍♂️

DM us or comment your EMAIL below for instant details! 📬



💊 The Pharmacist: More Than a Drug Expert... A Sentinel of Pharmacovigilance!On World Pharmacists Day, September 25th, w...
25/09/2025

💊 The Pharmacist: More Than a Drug Expert... A Sentinel of Pharmacovigilance!

On World Pharmacists Day, September 25th, we don't just celebrate a profession; we honour a noble mission and an essential link in the healthcare system.

🏨 Wherever you are—whether behind the pharmacy counter, in a hospital corridor, or in a research lab—you are not just an employee. You are a sentinel of pharmacovigilance.
Your role isn't limited to dispensing medicine; it extends far beyond:

▪️ A vigilant eye: You detect any potential drug interaction that could threaten patient safety.
▪️ A conscious mind: You review prescriptions to ensure their accuracy.
▪️ A trusted voice: You provide guidance and advice to patients, ensuring the safe and effective use of medication.

Your contribution to drug monitoring is key to protecting patients' lives. Every small piece of information about a side effect, a dosing error, or an unexpected reaction is a treasure that can save a life.

💡 PVigilant Health fully recognises that pharmacovigilance begins where you are. We invite you to be an active part of this system.

Don't hesitate to record and share your observations, as every step you take is a step toward improving the health of our community.

Happy Pharmacists Day! 🌷

Join us in the journey of pharmacovigilance. Your contribution makes a difference! 🤝



👥️ Join us for the Certification Program in Advanced Pharmacovigilance & Drug Safety Monitoring at Parul University!We'r...
21/09/2025

👥️ Join us for the Certification Program in Advanced Pharmacovigilance & Drug Safety Monitoring at Parul University!

We're excited to announce that Dr Ahmed Hegazy , Managing Director of PVigilant Health , will be a featured speaker. Dr Hegazy will be sharing his expertise in the "Journey of an Adverse Event" with a focus on PSMF Overview and PV Audit/Inspection.

This is your opportunity to learn from one of the 12 national and international experts in the field.

🗓 Don't miss out on Dr Ahmed's sessions, scheduled for:
* Oct 8, 7:00-8:00 PM
* Nov 5, 7:00-8:00 PM
* Nov 25, 8:00-9:00 PM

To register and secure your spot, visit the link provided ⬇️
https://forms.gle/6JdPdUZiFENSDSXa6




Is Your Patient's Spironolactone Prescription Hiding a Risk? 🤔​⚠️ Spironolactone is a cornerstone of therapy for heart f...
20/09/2025

Is Your Patient's Spironolactone Prescription Hiding a Risk? 🤔

⚠️ Spironolactone is a cornerstone of therapy for heart failure and hypertension, but a full understanding of its safety profile remains critical.

💡 This new pharmacovigilance study, analyzing over two decades of data from the FDA Adverse Event Reporting System (FAERS), uncovers potential safety signals that go beyond the well-documented side effects.

They identified significant statistical disproportionality for several rare, but serious, adverse events.

Find out more here ⬇️
https://www.researchgate.net/publication/395578863_Analyzing_real-world_adverse_events_of_spironolactone_with_the_FAERS_database




⚠️ While metformin is a cornerstone in diabetes management, its use in patients with renal impairment requires careful c...
17/09/2025

⚠️ While metformin is a cornerstone in diabetes management, its use in patients with renal impairment requires careful consideration!

Metformin is primarily cleared by the kidneys, and an accumulation of the drug can lead to a serious and potentially fatal condition known as lactic acidosis. 🩺

Understanding the link between metformin and kidney function is crucial for minimizing risks and optimizing patient outcomes.

Here's what you need to know:

📍 eGFR is the key: Before initiating metformin, you must assess the patient's estimated glomerular filtration rate (eGFR). Metformin is contraindicated in patients with an eGFR below 30 mL/min/1.73 m2. * A "gray area": Exercise caution when prescribing to patients with an eGFR between 30 and 45 mL/min/1.73 m2. Initiation of metformin isn't recommended in this group.

📍 Regular monitoring is a must: Monitor eGFR at least annually in all patients taking metformin. For those at higher risk of developing renal dysfunction, like older adults, more frequent monitoring is essential.

📍 Re-evaluating therapy: If a patient's eGFR drops below 45 mL/min/1.73 m2, it's time to re-evaluate the risks and benefits of continuing metformin.

✅️ By proactively managing and monitoring eGFR, you can confidently and safely use metformin, ensuring the best possible care for your patients.

❓️Question for Discussion: What protocols or tools do you use in your clinical practice to monitor kidney function in your patients on metformin?
Share your experience in the comments! 👇

⚠️ ​A 30-year-old patient with no history of hypertension is prescribed Prazosin for severe PTSD nightmares. A week late...
15/09/2025

⚠️ ​A 30-year-old patient with no history of hypertension is prescribed Prazosin for severe PTSD nightmares. A week later, they report feeling lightheaded upon standing!

💡​This common scenario highlights a critical pharmacovigilance challenge. The known side effect of orthostatic hypotension becomes a key safety signal in a new patient population. Additionally, we must track long-term efficacy and be vigilant for any new psychiatric side effects.

​It’s a clear example of how a drug's safety profile can change entirely with a different use.

What's your approach to monitoring this off-label therapy?
Share your professional insights in the comments below! 👇

💡 A chronic inflammatory disease that's more than skin deep, psoriasis is known to increase the risk of cardiovascular e...
13/09/2025

💡 A chronic inflammatory disease that's more than skin deep, psoriasis is known to increase the risk of cardiovascular events (CVEs). While systemic therapies have revolutionised treatment, their cardiovascular (CV) safety profiles are often unclear and inconsistently reported!

This new research, a systematic review of 195 studies involving nearly 1.8 million patients, uncovers the truth about the CV risks associated with these treatments.

💡 This study provides a critical, evidence-based roadmap for managing psoriasis patients, especially those with co-morbid cardiovascular risk factors.

By understanding the CV safety profiles of different therapies, you can make more informed treatment decisions, optimizing patient outcomes beyond just dermatological symptoms.

Find out more here ⬇️
https://www.researchgate.net/publication/395266232_Unravelling_the_Major_Cardiovascular_Risks_of_Systemic_Psoriasis_Medications_A_Literature_Systematic_Review




💡 Metformin is a powerful tool in diabetes management, but it's crucial to be aware of the serious, risk of metformin-as...
11/09/2025

💡 Metformin is a powerful tool in diabetes management, but it's crucial to be aware of the serious, risk of metformin-associated lactic acidosis (MALA).

⚠️ MALA can lead to severe outcomes, including death, hypothermia, hypotension, and bradyarrhythmia.

Understanding the risk factors is paramount for patient safety.

⚠️ ​Identify High-Risk Patients:

​Be vigilant with patients who have conditions that increase the risk of MALA. These include:

​▪️Renal dysfunction:
Impaired kidney function can lead to metformin accumulation.
▪️​Hypoxic states:
Conditions like congestive heart failure, myocardial infarction, sepsis, shock, and severe anemia create an environment ripe for lactic acid buildup.
▪️​Dehydration:
Severe vomiting or diarrhea can lead to volume depletion and renal impairment, increasing risk.
▪️​Excessive alcohol intake:
Alcohol potentiates metformin's effect on lactate metabolism.
▪️​Advanced age:
Patients 65 years and older are more likely to have underlying hepatic, renal, or cardiac issues.

💡 ​Clinical Best Practices:

✅️ ​Routine Renal Function Monitoring:
Assess renal function at least annually, and more frequently for older adults or high-risk patients.
✅️ ​Educate Patients:
Inform patients and their families about the symptoms of lactic acidosis, such as malaise, myalgia, respiratory distress, and abdominal pain. Instruct them to discontinue metformin immediately and seek medical attention if symptoms appear.
✅️ ​Immediate Action:
If MALA is suspected, discontinue metformin at once. Promptly initiate supportive hospital measures and consider immediate hemodialysis to remove accumulated metformin and correct the acidosis.

✅️ ​By staying alert to these risk factors and implementing these best practices, you can help mitigate the risk of MALA and ensure the safest possible care for your patients.

Prioritise your patients' safety. Share this vital information to help protect our community.

💡Gabapentin is a powerhouse for seizures and post-herpetic neuralgia, but its use extends far beyond the label—from neur...
09/09/2025

💡Gabapentin is a powerhouse for seizures and post-herpetic neuralgia, but its use extends far beyond the label—from neuropathic pain to anxiety and restless leg syndrome.

​With this broader use, new pharmacovigilance signals are emerging. We're not just monitoring for dizziness and sedation, but also subtle neurocognitive side effects and, critically, a growing potential for abuse and dependence—especially when co-prescribed with opioids.

​This is a testament to the power of real-world data. How has off-label Gabapentin use impacted your practice?

Share your professional insights in the comments below! 👇

💡 Discover key insights into two leading third-generation anti-seizure medications, cenobamate (CNB) and lacosamide (LCM...
06/09/2025

💡 Discover key insights into two leading third-generation anti-seizure medications, cenobamate (CNB) and lacosamide (LCM).

While both are crucial for treating drug-resistant epilepsy, this comprehensive analysis of real-world data from the FDA Adverse Event Reporting System (FAERS) reveals critical safety distinctions often unseen in clinical trials.

This research serves as a valuable resource for clinicians, offering a reference point for the clinical safety of CNB and LCM. It highlights the importance of individual patient tolerance and potential severe toxicity when selecting the most appropriate anti-seizure medication. Make informed decisions to optimize patient care and outcomes.

Find out more here ⬇️
https://www.researchgate.net/publication/395204834_Real-world_safety_comparison_between_cenobamate_and_lacosamide_a_pharmacovigilance_study_based_on_the_FDA_Adverse_Event_Reporting_System




💡 Understanding the link between NSAIDs and respiratory health is crucial. For certain patients, NSAID use isn't just ri...
02/09/2025

💡 Understanding the link between NSAIDs and respiratory health is crucial.
For certain patients, NSAID use isn't just risky—it can trigger NSAID-Exacerbated Respiratory Disease (NERD), leading to severe bronchospasm and life-threatening asthma attacks.

⚠️ This reaction occurs because NSAIDs inhibit COX-1 enzymes, which can increase the production of leukotrienes. These potent mediators cause airway inflammation, swelling, and constriction, rapidly worsening asthma symptoms.

⚠️ Identifying At-Risk Patients
Be vigilant with patients who have:
📍 Adult-onset asthma.
📍 Chronic rhinosinusitis with nasal polyps.
📍 A history of atopic disease.
📍 Severe or poorly controlled asthma.

✅️ When recommending pain relief, acetaminophen (paracetamol) is the safest option for these patients. It doesn't affect COX-1 enzymes or the leukotriene pathway.

✅️ Always advise patients to:
▪️ Strictly avoid all NSAIDs and aspirin.
▪️ Read medication labels carefully.
▪️ Consult a professional if unsure about a medication's safety.

✅️ By proactively educating patients and recommending safe alternatives, you can prevent serious respiratory episodes and ensure better patient outcomes.

Prescribing Propranolol for performance anxiety? Here's what to keep in mind from a pharmacovigilance perspective:​✅ Bas...
30/08/2025

Prescribing Propranolol for performance anxiety? Here's what to keep in mind from a pharmacovigilance perspective:

​✅ Baseline Matters: Bradycardia and hypotension may present differently in a non-hypertensive patient.

✅ Psychological Risks: Be vigilant for signs of medication dependency.

✅ Reporting is Key: Your reports on this patient group help build a comprehensive safety profile.

​This off-label use highlights the need for a nuanced approach to patient safety.

What PV concerns do you consider when prescribing Propranolol for anxiety?

Share your professional insights in the comments below ⬇️


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