Navigation Links
FDA Investigating Safety of Asthma Drug Xolair

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:
Related Image:
FDA Investigating Safety of Asthma Drug Xolair  
(Date:11/26/2015)... ... November 26, 2015 , ... ... of retro-fused, self-animating trailer titles with ProTrailer: Vintage. This newly styled ProTrailer pack ... trailer titles work with any font, giving users limitless opportunities to stylize and ...
(Date:11/25/2015)... ... November 25, 2015 , ... As part ... For Empowerment ™ attracts volunteers together who want to combine talents and resources ... key stakeholders in the process. The non-profit launched its first major fundraiser on ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... factory direct sauna parts and accessories. , Sauna accessories help improve the bather ... style and personality. From basic styles for the purist looking for simplicity in ...
(Date:11/25/2015)... ... November 25, 2015 , ... For the first time, Vitalalert is donating ... Beat ” campaign. The partnership between the two groups began in 2014 with Vitalalert ... cause. , MAP International was founded in 1954 and is an international Christian-based health ...
(Date:11/25/2015)... ... ... On November 25, 2015, officials of Narconon Arrowhead , the drug ... a new cutting edge recovery program that has been 50 years in the making. ... individuals with the purpose to free addicts from the symptoms and negative behaviors of ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 26, 2015 --> ... SyMRI to find optimal contrast weighting of MRI for ... has signed a research agreement with SyntheticMR in order to ... SyMRI, it is possible to generate multiple contrast images from ... patient has left, thus making it possible to both fine ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 ... has announced the addition of the  ... in the Global Cell Surface Testing ... Opportunities" report to their offering.  ... the addition of the  "2016 Future ...
(Date:11/26/2015)... , November 26, 2015 /PRNewswire/ ... --> adds "Global ... and "Investigation Report on China Repaglinide ... 2021 forecasts data and information to ... . --> ...
Breaking Medicine Technology: