FDA's statement on Xolair

On 7/16/09, the FDA issued a statement on Xolair. Preliminary data from the EXCELS trial showed an excess of cardiovascular and cerebrovascular events among patients taking Xolair.

Now for some background facts. Xolair is an injectable medication given to <1%>12 years old with moderate to severe disease, evidence of an allergic trigger of asthma, and lack of control with inhaled corticosteroids. The EXCELS is a 5-year observational trial. It is not designed to measure efficiacy, but safety. However, the study design is relatively loose, so I am not sure how strong the conclusions can be. Certainly a finding of more adverse effects is bothersome and should be followed up. More detailed analysis is being done. Another study would have to be done to determine cause and effect.

At present, I have not seen any of these adverse events in my practice. I shall be on the lookout for them and report them appropriately if they occur. Meanwhile, I would stay calm, wait patiently for the detailed analysis, and speak with my physician if you should have any additional concerns.