Parker Waichman LLP

FDA: Research Reveals Adverse Xolair Cardiovascular (Heart) and Cerebrovascular (Brain) Events

  Xolair Adverse Events. Federal regulators say that the asthma medication, Xolair (omalizumab), is associated with an increased risk for a number of cardiovascular reactions including, heart attack, mini-stroke, chest pain, and blood clots in the lungs and veins. The U.S. Food and Drug Administration (FDA) also indicated that it had added information concerning these […]

Xolair Drug and Cardiac Risks

 

Xolair Adverse Events. Federal regulators say that the asthma medication, Xolair (omalizumab), is associated with an increased risk for a number of cardiovascular reactions including, heart attack, mini-stroke, chest pain, and blood clots in the lungs and veins. The U.S. Food and Drug Administration (FDA) also indicated that it had added information concerning these increased risks and other potential risks to the Xolair label. The label change was made following the agency’s analysis of 25 clinical trials and a five-year study that was submitted by Genentech, the maker of Xolair. Genentech is a unit of Roche Holding AG and Xolair is marketed as part of a joint collaboration between Roche and Novartis AG.

What is Xolair?

Xolair is an injectable medication that was approved in 2003 for the treatment of moderate to severe asthma diagnosed in adults and children who are 12 years of age or older and for whom the condition is not controlled by inhaled steroids, known as corticosteroids. ‘Xolair’ is prescribed to patients diagnosed with asthma who test with increased levels of the antibody immunoglobulin E (IgE) in their blood. Increased blood IgE levels indicate the presence of perennial (year-round) airborne allergen. The drug is administered by a physician every two to four weeks and is only initially dispensed following a test to confirm an elevated blood IgE level. Asthma is a chronic disease that impacts the lungs’ airways and may lead to significant, even fatal, breathing issues.

The medication is also approved for the treatment of chronic idiopathic urticarial in adults and teenagers for whom hives are not controlled by H1 antihistamine treatment. Xolair is not approved for the treatment of other allergic conditions and other forms of urticaria, acute bronchospasm, or status asthmaticus.

FDA Review of Xolair

The FDA indicated that, while the data it reviewed suggests a serious safety signal, due to weaknesses in the way in which the safety study was designed and conducted, this led the agency to be “unable to definitively confirm or determine the exact increased level of these risks with ‘Xolair’.” According to the FDA, the issues have to do with the vessels that supply blood to the heart and brain, and include increased risks for pulmonary hypertension, or high blood pressure in the arteries of the lungs.

The FDA’s 2014 announcement comes after a statement it issued in 2009 when it indicated that it was reviewing interim safety findings following the five-year study that pointed to increased cardiovascular and cerebrovascular problems in people taking ‘Xolair’. At that time, no prescribing information changes were recommended.

The FDA has recently indicated that its review of the study revealed increased heart and brain blood vessel problems such as transient ischemic attacks (TIAs), which are known as mini-strokes; heart attacks; sudden, unexpected chest pain; pulmonary hypertension (high blood pressure in the arteries of the lungs); and blood clots in the lungs and veins.

Drug Maker Study Reveals Xolair Safety Risks

The study, “Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma” (EXCELS), was an observational study involving some 5,000 patients treated with Xolair, as well as a control group of some 2,500 patients who were not treated with Xolair. The study was implemented to evaluate the long-term safety profile of Xolair in patients who were followed for five years. Study participants were at least 12 years of age, were diagnosed with moderate to severe persistent asthma, who had received a positive skin or blood test for an aeroallergen.

The interim data submitted by Genentech suggests what the FDA described as a “disproportionate increase in ischemic heart disease; arrhythmias; cardiomyopathy and cardiac failure; pulmonary hypertension; cerebrovascular disorders; and embolic, thrombotic, and thrombophlebitic events” in patients who were treated with the medication, versus the control group who did not receive Xolair.

Prior Research Revealed Xolair Cancer Risks

Prior clinical trials also revealed an increased rate in the number of cancers in patients treated with Xolair. Although the FDA review did not reveal this increase, the FDA indicated that it could not rule out the potential risk and, therefore, has included this information on the “Warnings and Precautions” section of the Xolair label.

Need Legal Help Regarding Xolair?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Thanks to Waichman LLP for winning my case and Joarge Peniche for his work
Adrian Rubi
a year ago
5 Star Reviews 150
I would like to thank Kathy and Alex for all their hard work and dedication through out the entire process. I am very happy with the outcome of the case. I would highly recommend to my family and friends.
Alanah Rotunno
7 months ago
5 Star Reviews 150
I stumbled across Parker Waichman by a fluke and I took a chance on them handling my claim. I received regular updates, quick call backs, and the team that represented my case were smart, methodical and treated me like a human being, not just another number, thank you.
Joey Cook
8 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038