FDA adds cardiovascular risks to Xolair label for asthma treatment

The FDA has added label changes to omalizumab regarding a slightly increased risk for issues associated with heart and blood vessels supplying the brain in treating patients with asthma, according to a press release.

An FDA 5-year safety review of omalizumab (Xolair, Roche/Genentech and Novartis) found that a slightly higher rate of heart and brain blood vessel problems occurred in patients being treated with the injectable compared with those not treating with Xolair, the release said. The problems included ischemic attacks, heart attacks, unexpected chest pain, pulmonary hypertension and blood clots in the lungs and veins.

The FDA also found no difference in cancer rates among patients treated with the drug and those who were not treated with Xolair, a separate FDA MedWatch release stated. The agency reported, however, it could not rule out a potential risk for cancer with treatment, so the information was added to the Warnings and Precautions section of the drug label.

“Patients taking Xolair should continue to take the medication as prescribed and discuss any questions or concerns with their health care professionals,” the FDA wrote.

Xolair was approved in 2003 to treat patients aged 12 years or older with moderate to severe asthma whose symptoms are not well-controlled by corticosteroids. Xolair also is improved for treating chronic idiopathic urticaria in patients aged 12 years or older whose symptoms are not controlled by H1 antihistamine treatment, the release stated.