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.