FDA Update: Heart, Blood Vessel Risks Added to Asthma Drug Label

The Food and Drug Administration (FDA) has notified health care professionals that new risks have been added to the drug label for the asthma drug Xolair (omalizumab). New safety studies show that patients taking the drug are at a slightly higher risk for problems with the heart and blood vessels supplying the brain than patients not taking Xolair. Although the studies showed no increased rates of cancer in patients taking the drug, the FDA states that the potential risk of cancer cannot be ruled out. “Patients taking Xolair should continue to take the medication as prescribed and discuss any questions or concerns with their health care professionals,” noted the Agency. The FDA encourages health care professionals and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Read the full FDA Safety Alert.

Clinical Topics: Novel Agents

Keywords: Antibodies, Anti-Idiotypic, Antibodies, Monoclonal, Humanized, Asthma, Brain, Risk, Drug Labeling, Anti-Asthmatic Agents, Neoplasms, United States Food and Drug Administration

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