Systematic Review Analyzes Rare Modafinil-Associated Psychosis Across Published Clinical Reports
A systematic review of published case reports shows that modafinil exposure can trigger rare episodes of acute psychosis characterized by ...
Tag: Pharmacovigilance
Most Nigerian healthcare workers back ADR reporting but cite uncertainty as top barrier
A survey of 325 healthcare professionals in Cross River State, Nigeria, found 56 percent held positive attitudes toward adverse drug ...
Adverse Event Reporting Patterns Evaluated for Methoxy Polyethylene Glycol-Epoetin Beta
A disproportionality analysis of spontaneous reporting databases found that active comparator choice materially altered adverse event signal interpretation for methoxy ...
Clinicians Report Probable Stevens–Johnson Syndrome During Taletrectinib Therapy for Lung Cancer
Clinicians have reported a case of probable Stevens–Johnson syndrome linked to taletrectinib in a patient with ROS1-positive non-small cell lung ...
Pentosan Polysulfate Sodium Associated With Elevated Vision Impairment Reporting Signals
A FAERS pharmacovigilance study found pentosan polysulfate sodium had significantly higher reporting odds for vision impairment than other anticoagulants.
Precision Pharmacovigilance Merges Genomics and Real World Data to Protect Patients
A comprehensive review outlines how integrating proactive pharmacogenomic testing with real-world pharmacovigilance can transform drug safety and prevent adverse reactions.
Atorvastatin liver injury signals rise even as trials find statin safe in cirrhosis
A 2026 narrative review finds atorvastatin dominates statin-related liver injury reports in pharmacovigilance databases while trials show the drug is ...
FDA warning letters rarely mention AI, retrospective analysis finds
A retrospective analysis of 3,011 FDA warning letters issued from January 2022 to September 2026 found that only seven, or ...
Real-world drug studies reveal how chronic disease care diverges from clinical trials
A new editorial synthesizes 27 pharmacoepidemiology studies showing how real-world chronic disease care, from FAERS safety signals to national insurance ...
Réunion’s Monitored Chikungunya Epidemic Offers Preparedness Lessons for Europe
A Commentary on Réunion Island's intensively monitored 2024–25 chikungunya epidemic draws lessons on surveillance, healthcare surge capacity and emergency vaccine ...
First pan-RAS inhibitor shows vascular signals but no cardiac endpoint data yet
A review finds peripheral oedema and hypertension documented with daraxonrasib, but no published cardiac endpoint data at Phase 3 scale.
Knowledge Graph Boosts AI Extraction of Drug Side Effects from Patient Narratives
GraphRAG-ADR combines a knowledge graph with a large language model to extract adverse drug reactions from informal patient narratives, reaching ...
FDA Safety Reports Reassess Ultrasound Enhancing Agents Amid Pandemic Reporting Shifts
A re-analysis of FDA adverse event data from 2014 to 2024 finds that only 11.2% of the rise in serious ...
Nearly Half of HIV Patients in Nigerian Cohort Hit First Drug Reaction Within 13 Months
A retrospective cohort of 332 treatment-experienced adults with HIV at a Nigerian hospital found that nearly half experienced at least ...
Agentic AI speeds and standardizes detection of immune-related adverse events
A multi-phase Nature Cancer study found that an agentic AI system detected immune-related adverse events in clinical notes with retrospective ...
Breast Cancer Drug Reports Flag Liver-Related Events in FAERS Analysis
A FAERS analysis of 2,630 case reports found toremifene carried the strongest hepatobiliary adverse-event reporting signal among seven endocrine therapies ...
Largest Subject-Level Trial Analysis Finds No Raised Suicide Risk With GLP-1 Drugs
A subject-level analysis of 91 placebo-controlled trials covering nearly 108,000 participants found no increased risk of suicidal ideation or behavior ...
Final-Year Dentistry Students in UAE Show Gaps in Adverse Drug Reaction Reporting Knowledge
A survey of 152 final-year dentistry students at Ajman University found positive attitudes toward pharmacovigilance but limited knowledge and low ...
Proposed framework aims to link symptom and context changes in drug safety reports
A new Perspective proposes a minimal framework for documenting symptom trajectories, context, and actions in individual case safety reports, with ...
Kidney Injury Signals Flagged for Sacubitril/Valsartan in Japanese Adverse Event Database
A disproportionality analysis of Japan's JADER database found disproportionate acute kidney injury reporting signals for sacubitril/valsartan, with heart failure and ...
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