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.
You may also be interested in...
In response to the US agency's guidance announced Nov. 6, the pharmaceutical firm whose name is synonymous with the ingredient aspirin, Bayer, says it is considering how it will change labeling now used for most Bayer Aspirin products that includes a statement similar to the recommended language.
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.
Colgate agrees to purchase Hello Products direct-to-consumer oral care brand, complementing its Colgate brand and its Tom’s of Maine natural-positioned line. The firm will pay with a combination of cash and debt in the deal expected to close no later than the end of February.