Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Denies Bayer Petition For Aspirin As Primary Prevention Of Heart Attack, Stroke

This article was originally published in The Pink Sheet Daily

Executive Summary

Aspirin’s potential to prevent a first stroke or heart attack if used regularly does not outweigh the risks, including increased bleeding in the stomach and brain, FDA tells Bayer Healthcare in a letter denying the firm’s request to market the drug for primary prevention.

You may also be interested in...



Regular Aspirin Use To Prevent Cardiovascular Events Not Advisable For Most Patients – ACC/AHA Guidelines

Aspirin should be used very selectively in the primary prevention of artherosclerotic cardiovascular disease, according to new guidelines from the American College of Cardiology and American Heart Association. While certain higher-risk adults may benefit from regular, preventative aspirin use, those over the age of 70, and any at increased risk of bleeding, should explore lifestyle changes, the groups say.

ASPREE Results Support FDA Aspirin Label Guidance On Cardiovascular Disease

Data from ASPREE trial with more than 19,000 subjects show five-year-use of low-dose aspirin did not prolong disability-free survival and is associated with a significantly higher rate of hemorrhage and somewhat higher rate of all-cause mortality. Findings in three reports in NEJM track with US FDA's guidance that OTC aspirin marketers include a statement referring to doctors when aspirin package labels include a heart or other image suggesting a CV indication.

ASPREE Results Support FDA Aspirin Label Guidance On Cardiovascular Disease

Data from ASPREE trial with more than 19,000 subjects show five-year-use of low-dose aspirin did not prolong disability-free survival and is associated with a significantly higher rate of hemorrhage and somewhat higher rate of all-cause mortality. Findings in three reports in NEJM track with US FDA's guidance that OTC aspirin marketers include a statement referring to doctors when aspirin package labels include a heart or other image suggesting a CV indication.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS077205

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel