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FDA Changes Omalizumab (Xolair) Labeling, Cites Risk of Heart and Brain Problems
An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain in patients being treated with the asthma drug omalizumab (Xolair, Genentech/Novartis) than in those who were not treated with omalizumab. As a result, the agency has added information about these potential risks to the drug label.
The FDA approved omalizumab in 2003 to treat patients 12 years of age and older with moderate-to-severe persistent asthma who have a positive skin or blood test to year-round allergens in the air and whose symptoms are not well-controlled by inhaled corticosteroids. Omalizumab has been shown to reduce the number of asthma attacks in these patients.
Omalizumab is also approved for patients 12 years of age and older with chronic idiopathic urticaria who continue to have hives that are not controlled by treatment with H1 antihistamines.
The FDA’s review of a 5-year safety study found that a slightly higher rate of heart and brain blood-vessel problems occurred in patients treated with omalizumab compared with those not treated with omalizumab. The heart and brain blood-vessel problems included transient ischemic attacks (“min-strokes”), heart attacks, sudden chest pain, pulmonary hypertension, and blood clots in the lungs and veins. Although the data suggest a serious safety signal, because of weaknesses in how the safety study was designed and carried out, the FDA was unable to confirm or determine the exact increased level of these risks with omalizumab.
To further evaluate the heart and brain risks noted in the 5-year safety study, the agency reviewed a combined analysis of 25 randomized double-blind clinical trials comparing omalizumab with placebo. An increased risk of heart- and brain-related problems in patients treated with omalizumab was not noted in this combined analysis, but the low number of these events, the young patient population, and the short duration of follow-up prevented the investigators from making definite conclusions about the absence of a risk.
As a result of the FDA’s review of the safety study and of the combined clinical trials, it has added information about the potential risks of heart- and brain-related problems to the “adverse reactions” section of the drug label.
Previous clinical trials have shown slightly higher rates of various cancers in patients treated with omalizumab compared with those not treated with omalizumab. The FDA’s review of the 5-year safety study found no difference in the rates of cancer between patients treated with omalizumab and those not treated with the drug. However, because of limitations in the 5-year study, the agency cannot rule out a potential risk of cancer with omalizumab, and so it has added that information to the “warnings and precautions” section of the drug label.
Source: FDA; September 26, 2014.