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FDA says no to Bayer's request for aspirin label expansion

  • The U.S. regulator denies Bayer's (BAYRY +0.01%) request to change its aspirin labeling to include the claim of preventing heart attacks in patients with no history of cardiovascular disease. It cites the lack of data supporting the claim that the preventive benefits to a first attack outweigh the higher risks of bleeding in the stomach and brain.
  • There is evidence that the benefits of taking aspirin by patients who have already experienced a coronary event outweigh the increased risks of bleeding.
  • A 2010 study by Scottish researchers showed that aspirin did not prevent heart attacks or strokes in asymptomatic high risk people. The incidence of coronary events was similar to placebo.
  • Aspirin generated 916M euros ($1.27B) in sales last year.
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