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The FDA has warned that Xolair (omalizumab), a popular anti-asthma shot, has been linked to heart attacks, strokes, blood clots, and other severe side effects.

What is the problem?

In 2009, the U.S. Food and Drug Administration (FDA) first warned about reports of heart attacks and strokes in patients taking Xolair. In 2014, the FDA required new warnings on the label confirming cardiovascular side effects.

The new warnings came after the FDA reviewed data from a 5-year safety study and 25 trials comparing Xolair to a placebo. They determined that Xolair could increase the risk of life-threatening side effects, such as:

  • 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)

Xolair Black Box Warning

The Prescribing Information for Xolair contains a “Black Box” warning label about the risk of anaphylaxis, a whole-body allergic reaction that can occur after the first dose of Xolair. It can also occur beyond one year after beginning treatment. Symptoms may include bronchospasm, hypotension (low blood pressure), loss of consciousness, and severe swelling of the throat or tongue that can cut off the airway (angioedema).

Seek emergency medical treatment for signs of an allergic reaction:

  • Wheezing, chest tightness, or trouble breathing
  • Hives or skin rash
  • Feeling anxious or light-headed
  • Warmth or tingling under the skin
  • Swelling of the face, lips, or tongue

Xolair and Cancer

Malignant growths were observed in 0.5% of Xolair-treated patients compared with 0.2% of control patients in clinical studies. The most common observed malignancies included cancers of the breast, non-melanoma skin, prostate, melanoma, and parotid. Other studies have found no increased risk of cancer. However, because these studies were relatively short, cancer cannot be ruled out as a side effect of Xolair.

Xolair Side Effects

The most common side effects reported in patients taking Xolair for asthma included general pain, leg pain, fatigue, dizziness, fracture, arm pain, itching, dermatitis, and ear ache.

The most common side effects in patients on Xolair for the treatment of chronic idiopathic urticaria (chronic hives) included nausea, sinusitis, cold symptoms (nasopharyngitis), upper respiratory tract infection, joint pain, headache, and cough.

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