Heart attack or cancer are two possible side effects of the asthma medication, Xolair (omalizumab). In fact, the U.S. Food and Drug Administration (FDA) is conducting an evaluation of interim safety findings concerning an ongoing study of the asthma medication. The study suggests increased risks of adverse cardiovascular and cerebrovascular events in some patients using Xolair. Genentech, a unit of Roche Holding AG, is the maker of Xolair, which is jointly marketed by Roche and Novartis AG.
Xolair Maker Cites Potential Side Effects
The ongoing “Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma” (EXCELS) is being conducted to assess the long-term safety profile of Xolair in patients who have been followed for five years. The interim data, submitted by Genentech, suggests what it described as a disproportionate increase in:
- Ischemic heart disease
- Cardiomyopathy and cardiac failure
- Pulmonary hypertension
- Cerebrovascular disorders
- Embolic, thrombotic and thrombophlebitic events
Xolair is an injectable drug that was approved in 2003 for use by adults and adolescents who are 12 years of age an older; who have been diagnosed with moderate to severe persistent asthma; who test positive for reactivity to a perennial airborne allergen—or immunoglobulin E (IgE); and whose symptoms are not sufficiently controlled with an inhaled corticosteroids. According to Roche and Novartis, “IgE is an antibody that plays a major role in allergic asthma.”
Xolair is also approved to treat chronic idiopathic urticarial, which is a chronic type of hives, in adults and teenagers.
FDA Notes Possible Xolair Risks
The FDA indicates that Xolair raises the risk of the following and has added information of these potentially increased risks after an analysis of the five-year EXCELS study, and 25 clinical trials:
- Heart attack
- Mini stroke
- Chest pain
- Blood clots in the lungs and veins
- Pulmonary hypertension or high blood pressure in the arteries of the lungs
The problems appear to involve the vessels that supply blood to the heart and brain. The FDA’s review did not find a difference in cancer rates; however, due to study limitations, an increased risk of cancer could not be ruled out and that information has also been added to Xolair’s label.