FDA Looking Into Heart Problems From Study of Asthma Drug Xolair

Preliminary findings from an ongoing study of the asthma drug Xolair suggest the drug may be causing increased risks of heart disease, heart failure, and other severe problems, the Food and Drug Administration said today.

Xolair, known chemically as omalizumab, is approved to treat adults and children 12 and older with moderate to severe persistent asthma caused by a perennial airborne allergen who cannot achieve effective treatment using inhaled corticosteroids, such as Advair and Symbicort.

The FDA said safety findings from the current study of Xolair, called “Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS),” suggest patients are at greater risk of suffering ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events compared to patients not given the drug.

While the FDA has stopped short of ordering changes to Xolair’s labeling and is not thus far telling people who take the drug to stop doing so, the agency is cautioning physicians and patients to be aware of the new risks found in the EXCELS study. Once the study is completed, the FDA may decide to take further action with regard to the safety of Xolair.

Drugs Also Linked to Pneumonia Risk

Earlier this year, different research found that people using Advair and Symbicort were up to 70 percent more likely to develop pneumonia when the products were used to treat chronic obstructive pulmonary disease (COPD).

Advair is approved for treating COPD, but Symbicort is not. However, AstraZeneca, the maker of Symbicort, has said it would seek FDA approval for COPD treatments sometime in 2009.

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