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FDA Date: 9/25/14
Xolair (omalizumab) FDA Drug Safety Communication
FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events This update is in follow-up to the Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair) issued on July 16, 2009.
A U.S. Food and Drug Administration (FDA) review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair. As a result, we have added information about these potential risks to the drug label. Patients taking Xolair should continue to take the medication as prescribed and discuss any questions or concerns with their health care professionals.
FDA approved Xolair in 2003 to treat patients 12 years and older with moderate to severe persistent asthma who have a positive skin or blood test to year-round allergens in the air and whose symptoms are not well-controlled by asthma medicines called inhaled corticosteroids. Xolair has been shown to decrease the number of asthma attacks in these patients. Asthma is a chronic disease that affects the airways in the lungs and can cause serious trouble breathing, so it is important to take all asthma medicines exactly as they are prescribed. Xolair is also approved for patients 12 years and older with chronic hives without a known cause--a condition called chronic idiopathic urticaria or CIU--who continue to have hives that are not controlled by H1 antihistamine treatment.
Our review of a 5-year safety study found a slightly higher rate of heart and brain blood vessel problems occurred in patients being treated with Xolair compared to those patients not treated with Xolair. The heart and brain blood vessel problems included mini-strokes known as transient ischemic attacks or TIAs; 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. Although the data are suggestive of a serious safety signal, due to weaknesses in how the safety study was designed and carried out, we are unable to definitively confirm or determine the exact increased level of these risks with Xolair.
To further evaluate the heart and brain risks noted in the 5-year safety study, we reviewed a combined analysis of 25 randomized double-blind clinical trials comparing Xolair to a placebo, a treatment that does not contain any medicine. An increased risk of heart- and brain-related problems in patients treated with Xolair was not noted in this combined analysis, but the low number of these events, the young patient population, and the short duration of follow-up prevent us from making any definite conclusions about the absence of a risk. As a result of our review of the safety study and the combined clinical trials, we have added information about the potential risks of heart- and brain-related problems to the Adverse Reactions section of the drug label.
Some previous clinical trials have shown slightly higher rates of various cancers in patients treated with Xolair compared with non-Xolair-treated patients. 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, so we have added this information to the Warnings and Precautions section of the drug label.