FDA Approves Label Changes for Xolair Asthma Drug By Tod Aronovitz | 10/17/14 | 0 Comment

A small increased risk of heart and brain blood vessel complications has led to FDA-approved changes on the labeling for Xolair (omalizumab), an injectable drug that treats asthma. A drug safety communication was issued to alert pharmacy and health care professionals that the agency added this information to the ‘Warnings and Precautions’ section of Xolair’s drug label.

An FDA review of a five-year safety study suggests a slightly increased risk of adverse effects including:

  • Mini-strokes known as transient ischemic attacks or TIAs
  • Heart attacks
  • Sudden, unexpected chest pain
  • Pulmonary hypertension (high blood pressure in the arteries of the lungs)
  • Blood clots in the lungs and veins

The FDA review found no difference in cancer rates of patients using Xolair versus those who are not, but the agency says that it cannot rule out a potential risk of cancer because parameters in the five-year study could not definitively rule it out. Therefore, this information was also added to the medication’s ‘Warnings and Precautions.’

The FDA approved Xolair in 2003 to treat patients 12-years 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 asthma medicines called inhaled corticosteroids. Xolair has been shown to decrease the number of asthma attacks in these patients.

According to the FDA, patients should continue taking Xolair as directed by their doctors and follow up with them about any questions or concerns.

Healthcare professionals and patients are also encouraged to report any adverse events or side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form. Complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

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