FDA Warns of Small Cardio, Cerebrovascular Risk With Xolair
FDA Warns of Small Cardio, Cerebrovascular Risk With Xolair
A safety study conducted by the manufacturer of the asthma drug omalizumab (Xolair, Genentech) suggests it poses a slightly elevated but serious risk for heart attacks and ministrokes known as transient ischemic attacks, the US Food and Drug Administration (FDA) announced today.
The FDA qualified its warning by saying that because of "weaknesses" in the 5-year study's design and implementation, the agency is "unable to definitively confirm or determine the exact increased level of these risks with Xolair."
The label of omalizumab, also indicated for chronic idiopathic urticaria, features a boxed warning about the risk for anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and angioedema of the throat or tongue. The FDA today said it will add label information about the potential risks for cardiovascular and cerebrovascular problems, which also include unstable angina, venous thrombosis and pulmonary embolism, and pulmonary hypertension.
The 5-year observational safety study did not find that patients taking omalizumab had a higher rate of ischemic stroke or cardiovascular death compared with patients not treated with the drug.
In addition, the FDA will revise the drug's label to state it cannot rule out a potential risk for cancer. It noted that some earlier clinical trials detected a slightly higher cancer rate among patients treated with omalizumab compared with patients who did not receive the drug. The 5-year study did not uncover any difference in cancer rates among these 2 patient groups, but "limitations" in the study made it inconclusive.
More information about today's announcement is available on the FDA Web site.
To report problems with omalizumab, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
A safety study conducted by the manufacturer of the asthma drug omalizumab (Xolair, Genentech) suggests it poses a slightly elevated but serious risk for heart attacks and ministrokes known as transient ischemic attacks, the US Food and Drug Administration (FDA) announced today.
The FDA qualified its warning by saying that because of "weaknesses" in the 5-year study's design and implementation, the agency is "unable to definitively confirm or determine the exact increased level of these risks with Xolair."
The label of omalizumab, also indicated for chronic idiopathic urticaria, features a boxed warning about the risk for anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and angioedema of the throat or tongue. The FDA today said it will add label information about the potential risks for cardiovascular and cerebrovascular problems, which also include unstable angina, venous thrombosis and pulmonary embolism, and pulmonary hypertension.
The 5-year observational safety study did not find that patients taking omalizumab had a higher rate of ischemic stroke or cardiovascular death compared with patients not treated with the drug.
In addition, the FDA will revise the drug's label to state it cannot rule out a potential risk for cancer. It noted that some earlier clinical trials detected a slightly higher cancer rate among patients treated with omalizumab compared with patients who did not receive the drug. The 5-year study did not uncover any difference in cancer rates among these 2 patient groups, but "limitations" in the study made it inconclusive.
More information about today's announcement is available on the FDA Web site.
To report problems with omalizumab, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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