"Ticagrelor (Brilinta) has been promoted for years as a breakthrough in heart care, generating billions in sales and earning top placement in treatment guidelines across the world. It was positioned as a safer, more effective option than older blood thinners, and its reputation gave doctors reason to prescribe it widely. The problem is that the foundation supporting this drug was never solid."
"FDA Scientists Warned Ticagrelor Was Less Safe Than Advertised An in-depth investigation published in The BMJ revealed that the blockbuster anticlotting drug ticagrelor was approved over the strong objections of U.S. Food and Drug Administration (FDA) medical reviewers who warned the trial data was unreliable. The approval hinged on the PLATO trial - the massive study that secured ticagrelor's worldwide approval, which enrolled 18,624 patients across 43 countries. While the published results claimed a reduction in cardiovascular deaths, heart attacks, and strokes, U.S. patients actually fared worse on ticagrelor compared to clopidogrel (Plavix)."
Ticagrelor was marketed as a superior antiplatelet therapy and achieved widespread guideline placement and large sales. The PLATO trial, enrolling 18,624 patients across 43 countries, became the primary basis for global approval. U.S. Food and Drug Administration medical reviewers raised strong objections and warned that trial data were unreliable. Analysis showed inconsistent outcomes across regions and worse results for U.S. patients on ticagrelor compared with clopidogrel. Prescribing patterns were shaped by a narrative of superiority despite data concerns, exposing patients to potential avoidable risks and prompting calls for safer clinical choices and scrutiny of approval processes.
Read at Natural Health News
Unable to calculate read time
Collection
[
|
...
]