FDA Adds Risks for Heart and Brain Problems, Cancer to Xolair Label

The results of an FDA safety review of omalizumab (Xolair) suggest the asthma drug slightly elevates the risk of serious cardiovascular and cerebrovascular adverse events in patients.

While assessing 5-year safety data on Xolair, which is co-marketed by Genentech and Novartis, the FDA found a slightly higher rate of heart and brain blood vessel problems among asthma patients treated with the drug. According to the FDA, those problems included “mini-strokes known as transient ischemic attacks; heart attacks; sudden, unexpected chest pain; high blood pressure in the arteries of the lungs called pulmonary hypertension; and blood clots in the lungs and veins.”

In addition to uncovering possible heart- and brain-related risks, which have since been added to the drug label, the FDA could not rule out a potential risk for cancer with Xolair use, so it added that information to the label, as well.

“Our review of the 5-year safety study found no difference in the rates of cancer between those patients being treated with Xolair and those who were not being treated with Xolair. However, due to limitations in the 5-year study, we cannot rule out a potential risk of cancer with Xolair,” the FDA explained.

Xolair was originally approved in 2003 to treat patients 12 years and older with moderate to severe persistent asthma whose symptoms are not well controlled by inhaled corticosteroids. Xolair is also approved for use in chronic idiopathic urticaria patients 12 years and older who continue to exhibit hives that are not controlled by H₁ antihistamine treatment.

The FDA urged health care professionals to periodically reassess the need for continued Xolair therapy based on the patient’s disease severity and level of asthma control, as well as inform patients receiving Xolair not to decrease the dose or stop taking the drug, unless they have been instructed to do otherwise.