Omalizumab (Xolair) linked to Cardiovascular Adverse Events

Omalizumab (Xolair) linked to Cardiovascular Adverse Events

The popular asthma medication Xolair ,used in patients with moderate to severe asthma , was recently associated with adverse cardiovascular adverse events from the ongoing interim safety study entitled “Evaluating the Clinical Effectiveness and Long Term Safety in Patients with Moderate to Severe Asthma (EXCELS).”

In this safety study, those taking Xolair were shown to have an increase risk in the incidence of ischemic heart disease, arrhythmias, cardiomyopathy, cardiac failure, pulmonary hypertension, cerebovascular disorders and embolic, thrombotic and thrombophelbitic events,  compared to control subjects. But the Food and Drug Administration (FDA) is not issuing a warning or recommending changes to the use of Xolair.

As I read this study and the list of cardiovascular events Xolair is associated with, I sat there for about two minutes trying to think of any other serious cardiac event it wasn’t associated with. I couldn’t think of one. I was also flabbergasted that the FDA did not issue a warning – this alert was to Health Care Providers only stating that we just need to be aware of it and that if we did notice an adverse event to call the FDA’s MedWatch division.

Once again our FDA takes the mindset that this medication is safe until proven dangerous. Guess being associated with severe cardiac events isn’t serious enough.

References:

Medscape Medical News July 16 2009