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Xolair
Xolair Has Been Linked to Anaphylaxis
On February 21, 2007, the FDA announced that it requested Genentech, Inc. add a boxed warning to the product label for Xolair (Generic: Omalizumab). The boxed warning emphasizes that Xolair, used to treat patients with asthma related to allergies, may cause anaphylaxis. Anaphylaxis may include trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat. In addition, FDA has asked Genentech to revise the Xolair label and provide a Medication Guide for patients to strengthen the existing warning for anaphylaxis.The FDA approved Xolair in 2003 to treat adults and adolescents (12 years of age and older) with moderate to severe persistent asthma who have tested positive for a perennial aeroallergen (pollen, grass or dust) and whose symptoms are insufficiently controlled with inhaled steroids. In clinical trials, Xolair diminished the rate of asthma exacerbations, which were defined as a worsening of asthma that required treatment with systemic corticosteroids or a doubling of baseline inhaled corticosteroid dose.
The FDA received new reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with Xolair (Generic: Omalizumab). Typically these reactions take place within two hours of receiving a Xolair subcutaneous injection. However, these latest reports include patients who had delayed anaphylaxis; with onset two to 24 hours or even longer after receiving Xolair treatment. Anaphylaxis may occur after any dose of Xolair (including the first dose), even if the patient had no allergic reaction to the first dose. The symptoms and signs of anaphylaxis in these reported patients include bronchospasm, hypotension, syncope, urticaria, and angioedema of the throat or tongue.
Based on reports from approximately 39,500 patients, anaphylaxis following Xolair treatment occurred in at least 0.1% of treated people. Health care professionals who administer Xolair should be prepared to manage life-threatening anaphylaxis and should observe their Xolair-treated patients for at least two hours after Xolair is given. Patients under treatment with Xolair should be fully informed about the signs and symptoms of anaphylaxis, their chance of developing delayed anaphylaxis following Xolair treatment, and how to treat it when it occurs.
Legal Rights
If you or a loved one have been administered Xolair and experienced anaphylaxis, a life threatening allergic reaction you may be entitled to compensation. Please fill out the form at the right for a fee case evaluation by a qualified defective drugs attorney.
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Xolair Being Investigated for Possible Link to Heart Problems, Strokes
Jul 17, 2009 | Parker Waichman Alonso LLP
The asthma drug Xolair is undergoing a Food & Drug Administration (FDA) safety review because of a possible link to heart problems and strokes. However, despite the concerns, the FDA is not recommending any changes to the prescribing information for Xolair and is not advising patients to stop taking the drug at this time. Xolair is approved for use by adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who test positive for reactivity to a...
Xolair Linked to Risk for Delayed-Onset Anaphylaxis
Feb 22, 2007 | www.medscape.com
Omalizumab subcutaneous injection (Xolair, made by Genentech, Inc) may be linked to life-threatening anaphylaxis, according to a warning from the US Food and Drug Administration (FDA). Although most cases (71%) have occurred within 2 hours of omalizumab injection, some (13%) delayed-onset cases have been reported after 2 to more than 24 hours, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program. The FDA notes that anaphylaxis can...
FDA Issues New Warning About Asthma Drug Xolair
Feb 22, 2007 | NewsInferno.com
Citing reports of severe, potentially fatal allergic reactions, the U.S. Food and Drug Administration (FDA) has issued a new warning about omalizumab, an asthma drug marketed by Genentech as Xolair. The agency has requested a “black box” warning be added to the product’s label reflecting the risk of anaphylaxis. Xolair was approved by the FDA in 2003 to treat patients with allergy-related asthma. It was previously believed that the risk of anaphylaxis was most severe within...
FDA orders stronger asthma drug warning
Feb 21, 2007 | AP
The government ordered stronger label warnings for an injected asthma medication Wednesday because of reports some patients taking the drug, marketed as Xolair, had suffered a delayed and potentially life-threatening reaction known as anaphylaxis. A patient experiencing anaphylaxis might have trouble breathing, feel tight in the chest, have swelling in the mouth and throat, suffer dizziness or feel faint, or have itching and hives. The risk of anaphylaxis was known when Xolair, also called...
FDA Proposes to Strengthen Label Warning for Xolair
Feb 21, 2007 | www.fda.gov
The Food and Drug Administration (FDA) announced that it has requested Genentech, Inc. add a boxed warning to the product label for omalizumab, marketed as Xolair. The boxed warning emphasizes that Xolair, used to treat patients with asthma related to allergies, may cause anaphylaxis. Anaphylaxis may include trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat. In addition, FDA has asked Genentech to revise the Xolair label and provide...
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