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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Dear Health Care Provider Letter: Information Re Fluarix® (Influenza Virus Vaccine): Tip Caps Of The Prefilled Syringes May Contain Natural Rubber Latex Which May Cause Allergic Reactions in Latex Sensitive Individuals

August 16, 2010

Dear Healthcare Professional:

GlaxoSmithKline (GSK) Biologicals would like to inform you that the tip caps of the prefilled syringes in which FLUARIX is supplied may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals. Please note that the Prescribing Information packaged in cartons of FLUARIX for the 2010-2011 influenza season accompanied by this letter does not contain this information and is outdated. Revisions to the Prescribing Information and cartons are described below. An updated Prescribing Information is attached to this letter.

Updated Prescribing Information
The outdated Prescribing Information states that the tip caps of the needleless prefilled syringes do not contain latex and does not contain a warning that latex may cause allergic reactions in latex sensitive individuals.

To reflect that the tip caps of the prefilled syringes may contain natural rubber latex, the following lists the updated content of the Prescribing Information:

  • Highlights of Prescribing Information – Warnings and Precautions states: “The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.”
  • Warnings and Precautions Section 5.2 Latex states: “The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.”
  • Description Section 11 states: “The tip caps of the prefilled syringes may contain natural rubber latex. The rubber plungers do not contain latex.”
     
  • How Supplied/Storage and Handling Section 16 states: “The tip caps of the needleless prefilled syringes may contain natural rubber latex. Single-Dose Prefilled Disposable TIP-LOK Syringes (may contain latex) (packaged without needles).”

Updated Product Carton
Although, the back of the individual product cartons for FLUARIX state “Contains no latex,” stickers have been applied to the front of the individual product cartons to inform healthcare providers that: “The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals."

GSK is working to produce updated cartons with a latex-containing statement within which the updated prescribing information will be packaged.

Please see the attached updated Prescribing Information for FLUARIX. The Prescribing Information can also be found online at http://www.gsksource.com/gskprm/en/US/adirect/gskprm?cmd=ProductDetailPage&product_id=1244169218783&featureKey=600572#section-34067-9

In order for GSK to continue to monitor the safety of FLUARIX, we encourage healthcare professionals to report suspected adverse events to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 (www.vaers.hhs.gov), or GSK at 1-888-825-5249. If you have any questions concerning medical or other issues, please contact the GSK Response Center at 1-888-825-5249.

Sincerely,

Leonard Friedland, MD
Vice President, Clinical and Medical Affairs, Vaccines, North America
GlaxoSmithKline Biologicals

Enclosure: Updated Prescribing Information for FLUARIX