The U.S. Food and Drug Administration (FDA) recently reviewed its drug safety recommendations, suggesting an increase in the risk of heart and blood problems as a result of the use of Xolair (omalizumab), a drug is co-marketed by Novartis and Roche for the treatment of asthma. Despite the FDA’s new update of Xolair’s drug label and information about its potential risks and side-effects, the FDA recommends that patients continue their normal course of treatment.
The 5-year safety study conducted by the FDA revealed a higher rate of heart and brain blood vessel problems in patients administered Xolair than in patients who were not, including mini-strokes known as transient ischemic attacks (TIAs), heart attacks, sudden and unexpected chest pain, and pulmonary hypertension, which consists of high blood pressure in the arteries of the lungs, and blood clots in the lungs and veins.
“Although the data are suggestive of a serious safety signal, due to weaknesses in how the safety study was designed and carried out, we are unable to definitively confirm or determine the exact increased level of these risks with Xolair,” explains the FDA in its report about the study, which reviewed 25 randomized double-blind clinical trials that compared Xolair and placebo.
Even though the study didn’t report any substantial increase in the risk of heart- and brain-related problems in patients treated with Xolair, the FDA found it wise not to make any conclusions about the absence of risk due to the low number of these events, the young patient population, and the short duration of follow-up. Therefore, the information on risks to the heart and brain was also added to the Adverse Reactions section of the drug label.
Xolair was approved by the FDA in 2003 for the treatment of moderate to severe persistent asthma in patients older than 12 years old, with positive skin or blood test for year-round allergens in the air and with symptoms that cannot be treated with asthma medicines such as inhaled corticosteroids. It has shown to be effective in decreasing asthma attacks and can also be prescribed for chronic idiopathic urticaria (CIU), which is a condition characterized by chronic hives without a known cause and that cannot be treated with H1 antihistamine treatment.