Last week, the FDA gave asthmatic patients an important pause by adding a safety warning on the injectible drug Xolair.
A study held throughout the past five years have shown that 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 in a statement released to Reuters.
Turns out, this is important news for many of us in the allergy and asthma community for a boatload of reasons. Here’s why we should all pay attention: Xolair is currently FDA approved to treat two medical conditions, with a third important trial underway. All of these address different areas of our community.
Xolair was first approved by the FDA to treat asthma for those (ages 12 and older) who cannot control it through inhaled steroids like Qvar and Flovent.
Chronic Hives, Itchy Skin
Earlier this year, Xolair gained FDA approval to treat patients with chronic hives, or in fancy, science-y terms, Chronic Idiopathic Urticaria (CIU). If you’re not familiar with this particular medical issue, count yourself lucky; it is characterized by red, swollen, itchy and sometimes painful hives on the skin, which can show up randomly and last more than six weeks. Xolair has provided relief to patients who have had no luck with the typical antihistamine treatment.
What does an asthma drug have to do with food allergies? Plenty. It appears in initial trials that Xolair has some kind of magic in it that has something to do with IgE and Mast Cells and then somehow the people in the study are eating the very same food that could’ve killed them before. Allergic Living Magazine has a fantastic write-up about initial findings (which are stunning) that is well worth the read. Please note: It is a smidge more technical than my description.
What to do with all of this information? Do not panic. Review the FDA statement here. If you are currently receiving Xolair injections, talk with your doctor if you are concerned about what you’ve learned.
And, of course, if you feel you have experienced side effects from Xolair, don’t keep it to yourself; report side effects to the FDA here.