An ongoing study of the asthma drug Xolair indicates that it could cause a number of heart-related side effects, some of which could be fatal. The FDA issued an early communication indicating that they are reviewing the potential Xolair side effects, but that no conclusions have been reached.

>>FDA EARLY COMMUNICATION: Xolair Heart Side Effect Review

According to the statement issued by the FDA on July 16, 2009, interim data from a study conducted by Genentch, the manufacturer of Xolair (omalizumab), suggests that users of the drug could face an increased risk of heart attacks, strokes and other potentially life-threatening problems. At this time, no conclusions have been reached by the FDA about the causal connection between the study findings and Xolair side effects, but the information was provided to inform the public about an ongoing safety review of the drug.

The study, Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), compared the long-term safety of Xolair over five years use to a control group that was not using the drug. Out of 5,000 asthma suffers 12 years old or older, preliminary data has shown a disproportionate increase in:

  • Ischemic heart disease
  • Arrhythmias
  • Cardiomyopathy and Cardiac Failure
  • Pulmonary hypertension
  • Cerebrovascular disorders
  • Embolic, Thrombotic and Thrombophlebitic Events

Xolair was approved by the FDA in 2003 for treatment of moderate to severe persistent asthma caused by perennial airborne allergens, like pollen, grasses and dust. It is prescribed for those whose asthma cannot be controlled by inhaled corticosteroids.

The FDA is continuing to review the emerging safety issue and indicates that further guidance and recommendations will be provided after additional information is evaluated.


The product liability lawyers at Saiontz & Kirk, P.A. are closely following the FDA’s evaluation of the potential Xolair side effects to determine whether users who suffered heart attacks, strokes and other serious injuries may be entitled to compensation through an Xolair lawsuit.

Although legal claims are not actively being pursued at this time, if you, a friend or family member have experienced Xolair problems and wish to have a potential claim evaluated as part of our review, request a free consultation.