FDA to investigate Xolair's Heart risk

[AdminCM]

CMdeux Posted: 07/16/09 at 07:52 pm     

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http://www.webmd.com/asthma/news/20090716/fda-checking-heart-risk-of-xolair

The summary is pretty much:

July 16, 2009 -- The FDA is reviewing a possible link between the asthma drug Xolair and an increased risk of heart and cerebrovascular disorders.

Since the FDA investigation is still under way, the agency is not telling doctors to stop prescribing Xolair and is not recommending any changes to the prescribing information for Xolair.

The FDA is looking at interim results of an ongoing study of 5,000 patients with allergic asthma who take Xolair and 2,500 asthmatics who do not take Xolair.

Interim data, submitted by Xolair's manufacturer, Genentech, shows a disproportionate increase in heart and cerebrovascular events in patients treated with Xolair, compared to those who were not given the medication.

Worrisome.   

[LinksEtc]

Tweeted by @MatthewBowdish

"FDA says asthma drug Xolair raises risk of heart, brain problems"
http://www.reuters.com/article/2014/09/26/us-roche-xolair-safety-idUSKCN0HL2EN20140926?feedType=RSS&feedName=healthNews

The asthma drug Xolair is associated with a higher risk of heart attack, mini-stroke, chest pain and blood clots in the lungs and veins, among other problems, though the extent of increased risk is unclear, the U.S. Food and Drug Administration said on Friday.

[CMdeux]

Thank you for the update, Links.  I wonder what on earth the mechanism could be?? 

[LinksEtc]

Here's more info

"Omalizumab (Xolair) linked to higher risk of heart attack, mini-stroke (TIA), blood clots - FDA changes the label"

http://allergynotes.blogspot.com/2014/09/omalizumab-xolair-linked-to-higher-risk.html?utm_content=buffer0c6db&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer