FDA Reviews Possible Xolair Side-Effects

The US FDA is to conduct a safety review of asthma treatment drug Xolair.  Xolair is a drug primarily used to treat adults and adolescents who suffer from moderate-to-severe persistent asthma.

The FDA is concerned with the possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure and stroke.  The concern with Xolair and possible heart associated side-effects comes as a result of Genetech Inc.’s ongoing study of Xolair: Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma.

Once the FDA has completed the review, all findings and recommendations will be released to the public.  Until this time, all health care practitioners and patients should be aware of the review data that may suggest a risk of side-effects.  The FDA is, however, not advising a change in medical prescription of the drug at this time.