Update Regarding the Safety of Xolair
September 30, 2014 – The US Food and Drug Administration (FDA) reviewed a post marketing study that was conducted which showed a slight increase in the risk of severe side effects from using Xolair (omalizumab) and is now requiring labeling changes. Xolair, manufactured by Genentech and Novartis, is administered by a healthcare professional to treat patients over age 12 with persistent asthma who also tested positive for year round allergies and allergy symptoms that are not relieved by inhaled corticosteroids. Xolair was also approved for use in the treatment of hives from chronic idiopathic urticaria (unexplained intense itching) which is not managed with antihistamine therapy.
The new labeling requirements include notice to patients that Xolair may increase risk for blood clots, chest pain, heart attacks, pulmonary hypertension and transient ischemic attacks. This new caution is not a black box warning but additions that must be added to the Adverse Reactions section of the Xolair label. Additionally, the Warnings and Precautions section must include mention of the increased risk of cancer from using Xolair. Having said this, the FDA also stated that the results do not provide enough evidence for the degree of the risk so patients should not stop taking Xolair unless directed by their healthcare professional.
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Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Prices referenced are estimates based on available data and are subject to change at the time a claim is processed. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.