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Aspirin Professional Labeling Change Not Backed By Science – Bayer

This article was originally published in The Tan Sheet

Executive Summary

Aspirin professional labeling should not be modified to recommend a lower dosing range for secondary cardiovascular prevention, Bayer's Consumer Care Division says in recent comments to FDA

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NSA on McNeil aspirin petition

The National Stroke Association "urges" FDA to approve McNeil Consumer & Specialty Pharmaceuticals' citizen petition to amend professional labeling for aspirin to reflect a lower recommended maximum daily dose, in comments submitted May 23. Lowering the recommended daily dose to 75 mg -150 mg for secondary cardiovascular prevention and 50 mg -150 mg for secondary cerebrovascular prevention "is in keeping with [FDA's] Risk Minimization Action Plan and McNeil's long-term goal to minimize the risk to patients," NSA asserts. The risk of GI bleeding "increases monotonically with increasing aspirin doses, and cardiovascular and cerebrovascular disease benefit is no greater at aspirin doses above 150 mg than below 150 mg/day," the association adds. McNeil submitted the petition in January ( 1"The Tan Sheet" May 16, 2005, p. 6)...

NSA on McNeil aspirin petition

The National Stroke Association "urges" FDA to approve McNeil Consumer & Specialty Pharmaceuticals' citizen petition to amend professional labeling for aspirin to reflect a lower recommended maximum daily dose, in comments submitted May 23. Lowering the recommended daily dose to 75 mg -150 mg for secondary cardiovascular prevention and 50 mg -150 mg for secondary cerebrovascular prevention "is in keeping with [FDA's] Risk Minimization Action Plan and McNeil's long-term goal to minimize the risk to patients," NSA asserts. The risk of GI bleeding "increases monotonically with increasing aspirin doses, and cardiovascular and cerebrovascular disease benefit is no greater at aspirin doses above 150 mg than below 150 mg/day," the association adds. McNeil submitted the petition in January ( 1"The Tan Sheet" May 16, 2005, p. 6)...

NSA on McNeil aspirin petition

The National Stroke Association "urges" FDA to approve McNeil Consumer & Specialty Pharmaceuticals' citizen petition to amend professional labeling for aspirin to reflect a lower recommended maximum daily dose, in comments submitted May 23. Lowering the recommended daily dose to 75 mg -150 mg for secondary cardiovascular prevention and 50 mg -150 mg for secondary cerebrovascular prevention "is in keeping with [FDA's] Risk Minimization Action Plan and McNeil's long-term goal to minimize the risk to patients," NSA asserts. The risk of GI bleeding "increases monotonically with increasing aspirin doses, and cardiovascular and cerebrovascular disease benefit is no greater at aspirin doses above 150 mg than below 150 mg/day," the association adds. McNeil submitted the petition in January ( 1"The Tan Sheet" May 16, 2005, p. 6)...

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