FDA Issues Drug Safety Communication regarding Health Risks for Asthma Drug Xolair®
On September 26, the FDA issued a Drug Safety Communication regarding the health risks of the asmtha drug Xolair® (omalizumab).
In particular, the FDA warned that a 5-year safety study suggests a slightly increased risk of cardiovascular and cerebrovascular serious adverse events (as a result of heart and brain blood vessel problems) for patients being treated with Xolair® in comparison to patients not being treated with Xolair®. The heart and brain blood vessel problems included mini-strokes or transient ischemic attacks (TIA), heart attacks, chest pain, pulmonary hypertension, deep vein thrombosis, and pulmonary embolism. The FDA notes that “[a]lthough 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®.”
In light of these findings, the FDA has added information to the adverse event section of the product label to warn doctors and patients about the slightly increased risk of problems involving blood vessels supplying the heart and brain in Xolair®-treated patients. The FDA has also added information about uncertain findings regarding a potential risk of cancer to the “Warnings and Precautions” section of the Xolair® label.
Xolair® is an injectable asthma medication approved by the FDA in 2003 to treat moderate to severe persistent asthma. Xolair® is only used in asthma patients with elevated levels of EgE in their blood and a blood test is required before starting Xolair® to determining the correct dosing regimen.
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