Recent safety studies have linked Xolair (omalizumab), an anti-asthma shot, with higher rates of cancer, heart attack, mini-strokes, blood clots, and other life-threatening side effects.
Xolair Linked to Cardiovascular Side Effects
The U.S. Food and Drug Administration (FDA) began investigating cardiovascular side effects of Xolair in 2009, after early data from a 5-year safety study suggested a risk of heart attack and stroke.
In September 2014, the FDA concluded their investigation and found a slightly higher rate of the following side effects:
- Blood vessel problems in the heart and brain
- Blood clots
- Heart attacks
- Mini-strokes (transient ischemic attacks)
- Chest pain
- Pulmonary hypertension (high blood pressure in the lungs)
Although the data suggested a serious safety signal, the FDA could not definitively confirm or determine the exact increased level of these side effects due to weakness in how the study was designed and carried out.
Xolair Boxed Warning Label
The label on Xolair carries a “Black Box” warning about the risk of anaphylaxis, a severe whole-body allergic reaction that can be deadly. Patients can develop anaphylaxis after their first dose of Xolair or after taking it for more than one year. Anaphylaxis is a medical emergency because it can cause angioedema — severe swelling of the throat or tongue that can obstruct the airway.
Seek medical attention if you develop symptoms, such as:
- Wheezing, tightness in the chest, problems breathing
- Skin rash or hives (itchy or painful welts that spread when irritated)
- Anxiety or feeling light-headed
- Skin feels warm, tingly, tender, or swollen
- Swelling of the face, lips, or tongue
Xolair and Cancer
In clinical trials, malignant growths occurred in 0.2% of control patients and 0.5% of patients on Xolair. These cancers occurred in the breast, non-melanoma skin, prostate, melanoma, parotid, and other areas of the body. The 5-year safety study of Xolair found no evidence of a cancer risk. The FDA believes the risk is inconclusive because Xolair is a new drug, cancer often takes years to develop, and safety studies were relatively short.
Common Xolair Side Effects
For asthma patients: Most common Xolair side effects (>1% of patients) included general pain, leg pain, fatigue, dizziness, fracture, arm pain, itching, dermatitis, and ear ache.
For patients with chronic idiopathic urticaria (chronic hives): Most common Xolair side effects (>2% of patients) included nausea, cold symptoms (nasopharyngitis), sinusitis, upper respiratory tract infection, viral upper respiratory tract infection, joint pain (arthralgia), headache, and cough.