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Concerns over safety of Xolair

A safety review of the asthma drug Xolair has been requested by the FDA, after a study showed an increased number of heart attacks and strokes among patients who use Xolair.

Xolair is used in asthma patients where usual therapies do not help.

It is important to note that FDA did not recommend patients stop taking Xolair.

Xolair asthma medication

Xolair received US FDA approval in 2003 for treatment of moderate to severe persistent asthma, for those aged over 12 years old, who have been been unable to control their asthma by the usual therapy of inhaled corticosteroids.

It is administered by injection every other week in a doctor’s office. I was amazed to learn the estimated cost of the drug each year is about $19,000!

The drug omalizumab is branded as Xolair and is licensed for sale in the US, EU, Australia, Brazil, Canada, Dominican Republic, Guatemala, Israel, New Zealand and Venezuela.

Study raises concerns

An ongoing study has been tracking about 5000 Xolair treated patients and a control group of about 2500 non Xolair treated patients. The study started in 2004 and is planned to end in 2012. It was mandated by the FDA as part of the drugs approval process.

Early results have shown patients taking Xolair have an increase in heart disease, arrhythmias, stroke, heart attack, pulmonary hypertension and blood clots compared to the control group.

What should I do if I take Xolair?

The FDA recommends you continue taking Xolair! Visit the FDA website to read their full report, and see your doctor if you have any concerns. The FDA plans to investigate the drug and study further and has not reached a conclusion at this stage.

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About Kellie

Kellie is 37 years old and together with her brother Steve makes up the My Health Software team.

She helps on the websites and gathering news for the programs. Kellie worked in the medical industry prior to having her two children (8 and 6) and has a strong interest in self awareness and management of health conditions.


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