Navigation Links
FDA Investigating Safety of Asthma Drug Xolair
Date:7/16/2009

Injected medication may be linked to higher risk of heart attack, stroke, agency says,,

THURSDAY, July 16 (HealthDay News) -- The U.S. Food and Drug Administration has begun a safety review of the asthma drug Xolair (omalizumab) after reports of an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke, the agency said Thursday.

Early results from the Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS) trial spurred the investigation, the FDA said. The results indicate that Xolair boosts the risk of heart problems among users of the drug compared with nonusers.

The data from the trial was supplied to the FDA by Genentech, the maker of Xolair. The trial includes some 5,000 patients taking the drug and an additional 2,500 patients who are not using Xolair, according to the FDA.

Xolair, which is given by injection, is used for those people whose asthma is not controlled by inhaled corticosteroids.

Currently, the FDA is not telling people using Xolair to stop taking the drug. However, the agency believes patients and doctors should be aware of potential problems when taking the drug, including the possible risk of heart attack and stroke.

The final results of the study are not expected until 2012, and the FDA points out that factors other than the drug could be responsible for the increase in heart attack and stroke seen among users of Xolair.

Genentech spokeswoman Tara Cooper said the preliminary study results are not sufficient to prove the drug causes increased risk of heart attack and stroke.

"Limitations of the existing data preclude a definitive association with Xolair use," Cooper said. "At this time, there is insufficient information for the companies to change their assessment of the benefit-risk profile for Xolair. Physicians should continue to assess whether Xolair is appropriate for their individual patients."

One asthma expert was surprised by the FDA's action.

"In my experience, in properly selected patients, [Xolair] has been a great benefit and clinical improvement can be dramatic, on a case-by-case basis," said Dr. Clifford Bassett, a fellow at the American Academy of Allergy, Asthma and Immunology, and medical director of Allergy and Asthma Care of New York.

"As far as the possible events associated as indicated by the FDA release, I am surprised as I have not observed or seen those type of problems to date," he said.

Two years ago, the FDA warned of a connection between Xolair and anaphylaxis.

Anaphylaxis is a sudden, potentially life-threatening allergic reaction that can include trouble breathing, tightness in the chest, dizziness, fainting, itching and hives, and swelling of the mouth and throat.

At that time, the FDA asked Genentech to update the existing label warning and to provide a Patient Medication Guide with a strengthened warning for anaphylaxis.

More information

For more on asthma, visit the U.S. National Library of Medicine.



SOURCES: Clifford Bassett, M.D., fellow, American Academy of Allergy, Asthma and Immunology, and medical director, Allergy and Asthma Care of New York, New York City; Tara Cooper, spokeswoman, Genentech; July 16, 2009, news release, U.S. Food and Drug Administration


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. DEA Will Play Hardball in Investigating Michael Jacksons Doctors
2. Forensic Expert Investigating Chinese Drywall Issue
3. FDA Investigating Salmonella-Tainted Pistachios
4. Investigating a community where smoking rates are double the national average
5. Investigating causes of asthma attacks: New sensor system monitors environmental exposure
6. Micromet Receives Regulatory Approval to Conduct a Phase 2 Clinical Trial Investigating MT103 (MEDI-538) in Patients with Acute Lymphoblastic Leukemia
7. Consumer Specialty Products Association Responds to European Study Investigating Spray Products and Asthma
8. UT Southwestern investigating hypothermic technique in treating pediatric head injuries
9. CIFOR Guidelines for Foodborne Disease Outbreak Response Published by National Food Safety Group
10. American Imaging Management Debuts Patient Safety Podcasts
11. Study Evaluating Efficacy and Safety of Two Low-dose Regimens of PREMARIN Vaginal Cream for the Treatment of Moderate to Severe Vaginal Atrophy Now Published
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Investigating Safety of Asthma Drug Xolair  
(Date:2/24/2017)... ... February 24, 2017 , ... ... again hosted their Military Wedding Giveaway, with the winning couple announced on Feb. ... with services generously donated from local vendors: A Matter of Taste, Ryan Rousseau ...
(Date:2/23/2017)... ... February 23, 2017 , ... On February 22, ... a letter to withdraw previous guidance issued by the Obama Administration requiring ... issued in May 2016 by the Obama Administration came in response to a ...
(Date:2/23/2017)... (PRWEB) , ... February 23, 2017 , ... ... organization devoted exclusively to funding innovative lymphoma research and serving the lymphoma community ... will return to the La Gorce Country Club in Miami Beach to host ...
(Date:2/23/2017)... ... 2017 , ... The American Cleft Palate-Craniofacial Association (ACPA) is pleased to announce ... a longtime supporter of the event. , "We are pleased that KLS Martin is ... Havlik, 2017 ACPA President. "KLS Martin has a long track record of support of ...
(Date:2/23/2017)... Hollywood, CA (PRWEB) , ... February 23, 2017 , ... ... pleased to announce that they are sponsoring a raffle. Throughout the month of February, ... Winners will receive a gift card for a dinner for two at the Cheesecake ...
Breaking Medicine News(10 mins):
(Date:2/24/2017)... , Feb. 24, 2017 Medical information ... to increase their self-service capabilities to manage inquiries ... (HCPs). New research from consulting leader ... have developed self-service website portals where HCPs can ... just one of many findings to emerge from ...
(Date:2/24/2017)... , Feb. 23, 2017 The U.S. ... the PhenoTest BC Kit, performed on the Pheno ... organisms that cause bloodstream infections and provide information ... respond to (antibiotic sensitivity). The test also reduces ... this important information, which can guide antibiotic treatment ...
(Date:2/24/2017)... MELBOURNE , Australien, 24. Februar 2017 /PRNewswire/ ... innovatives, diversifiziertes Unternehmen des Gesundheitsbereiches, ist erfreut, für ... Vergleich mit dem entsprechenden Vorjahreszeitraum exzellente Ergebnisse vorlegen ... BioMedical und Aktualisierung zum Wachstum" finden Sie ... Gewinn nach Steuern 2,12 Millionen USD (Dez. 2015: ...
Breaking Medicine Technology: