Signal Evaluation
Explore all topics, guides, and frameworks related to Signal Evaluation.
Articles in this section
16- Historical Signal Evaluation: Fluoroquinolones and Aortic Aneurysm or Dissection A detailed evaluation of the fluoroquinolone–aortic aneurysm or dissection signal, examining epidemiological evidence, biological plausibility, confounding, susceptible populations, regulatory assessment and changes to product information. Read Article →
- Thalidomide and Congenital Malformations: A Historical Signal Evaluation How clinicians recognised the thalidomide teratogenicity signal, how the evidence accumulated despite major limitations in contemporary pharmacovigilance, and what the tragedy taught about signal detection, causality and regulatory oversight. Read Article →
- Statins and Tendon Rupture: A Signal Evaluation An evidence-based evaluation of the proposed association between statins and tendon rupture, showing how positive case reports and rechallenge findings can be weighed against larger epidemiological studies and important confounding factors. Read Article →
- Proton Pump Inhibitors and Hypomagnesaemia: A Signal Evaluation A practical signal evaluation of proton pump inhibitors and hypomagnesaemia, showing how dechallenge, rechallenge, class effects, latency and mechanistic evidence can strengthen causal assessment. Read Article →
- SSRIs and Postpartum Haemorrhage: A Signal Evaluation A practical signal evaluation of SSRI exposure and postpartum haemorrhage, examining the literature, exposure timing, biological plausibility, confounding, absolute risk and the evidence for causality. Read Article →
- Isotretinoin and Teratogenicity: A Historical Signal Evaluation How evidence of isotretinoin-associated embryopathy accumulated from early reports to a well-established safety risk, and how pharmacovigilance evidence translated into increasingly stringent pregnancy-prevention measures. Read Article →
- Signal Evaluation: Bisphosphonates and Atypical Femoral Fractures A historical signal-evaluation case study showing how reports of unusual femoral fractures evolved into evidence of a rare bisphosphonate-associated adverse effect, and how duration, discontinuation, biological plausibility and absolute risk shaped the final benefit-risk assessment. Read Article →
- Signal Evaluation: Fluoroquinolones and Tendon Injury and Tendon Rupture A historical signal-evaluation case study showing how fluoroquinolone-associated tendon injury evolved from clinical reports into a well-characterised safety concern involving timing, Achilles tendon injury, corticosteroid exposure, patient susceptibility and class-wide regulatory restrictions. Read Article →
- Signal Evaluation: SSRIs and Persistent Pulmonary Hypertension of the Newborn A historical signal-evaluation case study showing how an initially strong association between late-pregnancy SSRI exposure and persistent pulmonary hypertension of the newborn was reassessed as additional evidence accumulated, with particular attention to confounding by maternal illness and the difference between relative and absolute risk. Read Article →
- Signal Evaluation: GLP-1 Receptor Agonists and Acute Pancreatitis A practical signal-evaluation case study showing how the pancreatitis signal associated with GLP-1 receptor agonists evolved from spontaneous reports and mechanistic concern to extensive clinical and epidemiological evaluation, and why the final interpretation requires careful separation of association, causality and class effect. Read Article →
- Signal Evaluation: DPP-4 Inhibitors and Bullous Pemphigoid A practical signal-evaluation case study showing how a rare autoimmune skin disorder moved from case reports and disproportionality to epidemiological confirmation, regulatory action and a more refined understanding of class and molecule-specific risk. Read Article →
- Historical Signal Evaluation: Pioglitazone and Bladder Cancer How the pioglitazone–bladder cancer signal evolved, why epidemiological studies produced conflicting results, how exposure duration and confounding affected interpretation, and how regulators translated uncertainty into risk-minimisation measures. Read Article →
- Historical Signal Evaluation: SGLT2 Inhibitors and Diabetic Ketoacidosis An evidence-based evaluation of the SGLT2 inhibitor–diabetic ketoacidosis signal, examining atypical presentation, pharmacological plausibility, spontaneous reports, clinical-trial evidence, observational studies, risk factors, PRAC assessment and regulatory risk minimisation. Read Article →
- Evaluating the Statin–Rhabdomyolysis Signal: From Spontaneous Reports to Dose, Drug Interactions and Causal Assessment How the statin–rhabdomyolysis signal was evaluated, why raw reporting numbers can mislead, and how dose, pharmacokinetics, drug interactions and patient factors determine the clinical interpretation of muscle toxicity. Read Article →
- Evaluating the Fluoroquinolone–Aortic Aneurysm and Dissection Signal: From Signal Detection to Regulatory Action A detailed evaluation of how the fluoroquinolone–aortic aneurysm and dissection signal evolved from an epidemiological concern into regulatory action, including the evidence that supported the signal and later studies that challenged its causal interpretation. Read Article →
- Historical Signal Evaluation: Metamizole and Agranulocytosis A reconstruction of the 2024 EU metamizole–agranulocytosis review, from the regulatory trigger and available evidence through PRAC assessment, risk-minimisation conclusions and changes to product information. Read Article →