Xolair Pediatric Use Approved, Despite Health Risks, Heart Concerns

Despite long-standing concerns that side effects of Xolair may increase the risk of heart attacks and other health problems, use of the asthma injection among children was recently approved by federal drug regulators. 

In a press release issued on June 7, Genentech announced that the FDA has approved Xolair for pediatric use among children ages six and up. The approval allows the company to expand the market for Xolair to include children between the ages of six and 11, as the drug was already approved among adults and children ages 12 and older for the treatment of moderate to severe persistent allergic asthma.

Xolair (omalizumab) is a subcutaneous injection that was first introduced in 2003, for patients who suffer from moderate to severe asthma that is not well controlled by inhaled corticosteroids. It is also approved for use among patients 12 and older with chronic idiopathic urticaria (CIU), which involves chronic hives without a known cause.

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Following a review of data from a 5 year safety study conducted by Genentech, known as EXCELS (“An Epidemiologic Study of Xolair (omalizumab): Evaluating Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma”), the FDA issued a Xolair drug safety communication in 2014, ordering the drug maker to add warnings to the Adverse Reactions section of the drug label about an increased rate of cardiovascular and cerebrovascular serious events. In addition, information was added to the Warnings and Precautions section about a potential Xolair cancer risk.

The FDA first raised concerns about the potential risk of Xolair heart problems in 2009, after preliminary data from the same study identified a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy, heart failure, pulmonary hypertension, cerebrovascular disorders and problems associated with blood clots, like pulmonary embolism.

According to Genentech, clinical trials indicated that the drug was effective in lowering asthma exacerbations in children compared to a placebo. The studies found that the most common side effects were common cold symptoms, headache, fever, upper abdominal pain, sore throat, ear pain, intestinal infections, nausea, vomiting, an increased rate of receiving insect bites and nose bleeds.

The drug is promoted in the U.S. by Genentech and Novartis.

In 2007, the FDA required Genentech to add a new “black box” warning about Xolair side effects, indicating that users may suffer serious and potentially fatal allergic reactions, known as anaphylaxis. About one in 1,000 patients may experience problems, regardless of the dose or how long they have used the medications.

Symptoms of anaphylaxis reactions from Xolair may include trouble breathing, chest tightness, dizziness, fainting, itching, hives, and swelling of the mouth and throat.

In 2014, a report by the Institute for Safe Medication Practices (ISMP) raised questions about the large number of hypersensitivity problems among Xolair users reported to the FDA, suggesting that the rates are high enough to raise questions about whether Xolair should remain on the market.


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