Signal Evaluation
Explore all topics, guides, and frameworks related to Signal Evaluation.
Articles in this section
16- Thalidomide and Congenital Malformations: A Historical Signal Evaluation Explains how clinicians recognised thalidomide teratogenicity before modern safety databases existed, why phenotype and developmental timing were powerful evidence, and how converging observations drove regulatory change. Read Article →
- Statins and Tendon Rupture: A Signal Evaluation An evidence-based evaluation of the proposed association between statins and tendon injury, distinguishing tendinopathy from tendon rupture and showing how conflicting evidence should be integrated. Read Article →
- Signal Evaluation: SSRIs and Persistent Pulmonary Hypertension of the Newborn A structured historical signal evaluation showing how the apparent association between late-pregnancy SSRI exposure and PPHN changed as larger studies better addressed maternal illness, confounding and absolute risk. Read Article →
- SSRIs and Postpartum Haemorrhage: A Signal Evaluation A practical signal-evaluation case study showing how late-pregnancy SSRI exposure and postpartum haemorrhage should be assessed across observational evidence, mechanism, confounding and clinical context. Read Article →
- Historical Signal Evaluation: Metamizole and Agranulocytosis A reconstruction of the 2024 EU reassessment of a known serious metamizole risk, showing how pharmacovigilance evaluates whether existing risk-minimisation measures remain adequate. Read Article →
- Historical Signal Evaluation: SGLT2 Inhibitors and Diabetic Ketoacidosis A structured historical signal evaluation showing how SGLT2 inhibitor-associated ketoacidosis was recognised despite rarity and sometimes modest glucose elevation, and how pharmacology, clinical context and regulatory evidence were integrated. Read Article →
- Proton Pump Inhibitors and Hypomagnesaemia: A Signal Evaluation A practical case study showing how rare but clinically informative dechallenge and rechallenge patterns can strengthen a pharmacovigilance signal despite heterogeneous population evidence. Read Article →
- Pioglitazone and Bladder Cancer: A Historical Signal Evaluation Explains how a possible cancer signal was evaluated across conflicting evidence, why exposure duration and confounding mattered, and how regulators acted under uncertainty without treating every association as definitive causality. Read Article →
- Isotretinoin and Teratogenicity: A Historical Signal Evaluation How isotretinoin teratogenicity became an established serious risk and why pharmacovigilance then shifted from causal detection to prevention of fetal exposure and evaluation of risk-minimisation effectiveness. Read Article →
- Signal Evaluation: GLP-1 Receptor Agonists and Acute Pancreatitis A structured signal-evaluation case study showing how a plausible pancreatitis concern must be separated from the high background risk of the treated population, product-specific evidence and evolving comparative data. Read Article →
- Historical Signal Evaluation: Fluoroquinolones and Aortic Aneurysm or Dissection A structured historical signal evaluation showing how a serious vascular concern supported regulatory risk minimisation despite residual confounding and later evidence that refined the relative strength of the aneurysm and dissection components. Read Article →
- Fluoroquinolones and Tendon Injury: A Signal-Evaluation Case Study Explains how a class safety signal progressed from clinical reports to a well-characterised risk, and how timing, Achilles tendon involvement, corticosteroid exposure, age and renal impairment refined regulatory action. Read Article →
- Evaluating the Fluoroquinolone–Aortic Aneurysm and Dissection Signal: From Detection to Regulatory Action A process-focused case study showing how a safety signal can progress from uncertain epidemiological evidence to product-information action and then be refined when better-controlled studies challenge the apparent magnitude or causal interpretation. Read Article →
- Evaluating the Statin–Rhabdomyolysis Signal: From Detection to Risk Characterisation Explains how the statin–rhabdomyolysis signal evolved from rare serious reports into a differentiated risk model shaped by individual statins, dose, exposure, interactions and patient susceptibility. Read Article →
- Signal Evaluation: DPP-4 Inhibitors and Bullous Pemphigoid A structured signal-evaluation case study showing how a rare, clinically specific autoimmune blistering disorder moved from individual reports to epidemiological confirmation, while preserving uncertainty about molecule-specific risk and mechanism. Read Article →
- Signal Evaluation: Bisphosphonates and Atypical Femoral Fractures A case study covering phenotype, epidemiology, duration, discontinuation, biological plausibility, regulatory assessment and absolute risk. Read Article →