Anaphylaxis in Medical Technology

Study Shows Potential Benefits of Xolair(R) in Treating Children Suffering from Moderate or Severe Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids

... treatment. A severe allergic reaction called anaphylaxis has happened in some patients after they received Xolair. anaphylaxis is a life-threatening condition. Seek emergency ... away if symptoms occur. Signs and symptoms of anaphylaxis include: -- wheezing, shortness of breath, ...

MedImmune Presents New Pharmaco-Economic Data at American Academy of Pediatrics Regarding Infants at High Risk for RSV

... http://www.medimmune.com . Very rare cases (<1 per 100,000 patients) of anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. Cases of anaphylaxis were reported following re-exposure to Synagis and rare severe ...

MedImmune's Motavizumab Reduced RSV Hospitalizations by 83 Percent Among High-Risk Native American, Full-Term Infants in Placebo-Controlled Phase 3 study

... doses throughout the season. Very rare cases (<1 per 100,000 patients) of anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. Cases of anaphylaxis were reported following re-exposure to Synagis and rare severe ...

Schering-Plough Highlights Hepatitis C Clinical Data Presentations at the European Association for the Study of the Liver (EASL) Annual Meeting

... hepatic failure, increases in serum creatinine in patients with renal insufficiency, acute hypersensitivity (angioedema, bronchoconstriction, anaphylaxis and cutaneous eruptions) and hypertriglyceridemia. During the course of therapy lasting up to 48 weeks in patients ages 3 through 17 years ...

Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients

... hepatic failure, increases in serum creatinine in patients with renal insufficiency, acute hypersensitivity (angioedema, bronchoconstriction, anaphylaxis and cutaneous eruptions) and hypertriglyceridemia. During the course of therapy lasting up to 48 weeks in patients ages 3 through 17 years ...

FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C

... hepatic failure, increases in serum creatinine in patients with renal insufficiency, acute hypersensitivity (angioedema, bronchoconstriction, anaphylaxis and cutaneous eruptions) and hypertriglyceridemia. During the course of therapy lasting up to 48 weeks in patients ages 3 through 17 years ...

CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency

... not indicated for dysfibrinogenemia. RiaSTAP is contraindicated in individuals who have had severe immediate hypersensitivity reactions, including anaphylaxis to RiaSTAP or its components. Physicians should monitor patients for early signs of allergic or hypersensitivity reactions and if necessary, ...

More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies

... limit of normal at 2 consecutive visits versus five (1.7%) patients treated with deferoxamine. Serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving Exjade, with the onset of the reaction occurring in the majority of cases within the first ...

FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment for Routine Prophylaxis in Children with Hemophilia A

... joint damage. The most serious adverse reactions are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis and the development of high-titer inhibitors necessitating alternative treatments to AHF. The most common adverse reactions observed in clinical ...

FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) to Full Approval for Use in Cutaneous T-Cell Lymphoma (CTCL)

... (28%), rash (25%), chest pain or tightness (24%), tachycardia (12%), dysphagia or laryngismus (5%), syncope (3%), allergic reaction (1%), or anaphylaxis (1%). These events were severe in 2% of patients. -- Death during infusion has been reported. Vascular Leak Syndrome -- This syndrome, ...

Study Shows Physician Judgment is Important in Reducing Rate of RSV-Related Hospitalizations Among High-Risk Infants

... one million children in the U.S. since its introduction in 1998. Very rare cases (<1 per 100,000 patients) of severe allergic reactions such as anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. These rare reactions may occur when any dose of Synagis ...

Phase 3 Data Regarding Anti-RSV Antibody To Be Presented at Pediatric Academic Societies (PAS) Annual Meeting

... among Native American infants at high risk for serious RSV disease. Very rare cases (<1 per 100,000 patients) of severe allergic reactions such as anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. These rare reactions may occur when any dose of Synagis ...

New England Journal of Medicine Study Shows ERBITUX(R) Improves Survival in Advanced Colorectal Cancer

... infusions. Monitor patients for 1-hour following ERBITUX infusions in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g., epinephrine, corticosteroids, intravenous antihistamines, bronchodilators, and oxygen). Longer observation periods may be required in patients ...

Study Shows Need to Test More COPD and Asthma Patients for Underdiagnosed Pulmonary Disease

... adult individuals as they may experience severe reactions, including anaphylaxis: individuals with a known hypersensitivity and/or history of anaphylaxis or severe systemic reaction to Alpha-1 Proteinase Inhibitor products or their components and individuals with selective IgA deficiencies who have ...

Regado Biosciences Initiates Phase IIa Clinical Study of REG1 Anticoagulation System

... the risk for developing heparin-induced thrombocytopenia (with or without thrombosis), as well as protamine-associated side effects, such as anaphylaxis and systemic hypotension. About REG1 Anticoagulation System Regado's lead product candidate, REG1, is the first specific, direct-acting, ...

Bayer Issues Additional Guidance to Physicians on Trasylol(R)

... bypass can be rapidly initiated. The benefit of Trasylol(R) to patients undergoing primary CABG surgery should be weighed against the risk of anaphylaxis associated with any subsequent exposure to aprotinin. (See CONTRAINDICATIONS, WARNINGS and PRECAUTIONS in the prescribing information.) Safety ...

Survival Data in FDA Approval for ERBITUX(R) (Cetuximab) Supports use as a Single Agent in Patients with Advanced Colorectal Cancer

... infusions. Monitor patients for 1-hour following ERBITUX infusions in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g., epinephrine, corticosteroids, intravenous antihistamines, bronchodilators, and oxygen). Longer observation periods may be required in patients ...

FDA Advisory Committees Recommend Continued U.S. Marketing Authorization for Trasylol(R)

... bypass can be rapidly initiated. The benefit of Trasylol(R) to patients undergoing primary CABG surgery should be weighed against the risk of anaphylaxis associated with any subsequent exposure to aprotinin. (See CONTRAINDICATIONS, WARNINGS and PRECAUTIONS in the prescribing ...

MedImmune Announces Positive Clinical Results at PAS Annual Meeting From Large Prospective Trial in Prevention of Serious RSV Disease

... throughout the season. Very rare cases (<1 per 100,000 patients) of anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. Cases of anaphylaxis were reported following re-exposure to Synagis and rare severe ...

New Study in Journal of Pediatrics Suggests Synagis (Palivizumab) May Reduce Subsequent Recurrent Wheezing in Preterm Infants

... . Very rare cases (<1 per 100,000 patients) of anaphylaxis and rare (<1 per 1,000 patients) severe acute hypersensitivity reactions have been reported with Synagis. Cases of anaphylaxis were reported following re-exposure to Synagis and rare severe ...

Large Geographic Differences in EpiPen Prescriptions in the U.S., From the Journal of Allergy and Clinical Immunology

... /PRNewswire/ -- A new study suggests strong variation in the occurrence of anaphylaxis between the northern and southern U.S. anaphylaxis is a severe allergic reaction that can be fatal without treatment with ...

Large Study Shows that Presence of Neutralizing Antibodies Did Not Predict Clinical Response to Betaseron Treatment

... should be advised of the importance of rotating injection sites. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. See "Warnings," "Precautions," and "Adverse Reactions" sections of full Prescribing Information. About Berlex Berlex, ...

New One-Year Pharmacoeconomic Study Shows Avonex is Cost-Effective Relative to Other Interferon Therapies for Multiple Sclerosis

... for signs of hepatic injury. Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX. Rare cases of anaphylaxis have been reported. Please see complete prescribing information available at www.AVONEX.com. About Biogen Idec Biogen Idec creates new standards ...

First of Its Kind Data Show: Immediate Treatment of Early MS Patients with Betaseron Significantly Delayed Permanent Disability

... should be advised of the importance of rotating injection sites. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. See "Warnings," "Precautions," and "Adverse Reactions" sections of full Prescribing Information. About Bayer HealthCare ...

Studies Presented at Neurology Conference Highlight Early Efficacy, Long-Term Tolerability, and High Patient Satisfaction with Betaseron

... should be advised of the importance of rotating injection sites. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. See "Warnings," "Precautions," and "Adverse Reactions" sections of full Prescribing Information. About Bayer HealthCare ...

Ontak (denileukin diftitox) Achieves 49.1% Overall Response Rate in Phase III Trial of Cutaneous T-Cell Lymphoma (CTCL)

... rash (25%), chest pain or tightness (24%), tachycardia (12%), dysphagia or laryngismus (5%), syncope (3%), allergic reaction (1%) or anaphylaxis (1%). -- These events were severe in 2% of patients. Death during infusion has been reported. Vascular Leak Syndrome: -- ...

First Demonstration of nanoImmunology: a Nanomaterials-based Therapeutic Approach to Treat Allergy

... issue of the Journal of Immunology. This research was supported in part by grants from the National Institutes of Health and the Food Allergy and anaphylaxis Network. A copy of the study is available to reporters in PDF format by email request from the American Association of Immunologists at ...