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Label Changes for:

Gardasil (Human Papillomavirus Quadrivalent Types 6, 11, 16, 18) Recombinant Vaccine

July 2009

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009

WARNINGS and PRECAUTIONS

  • addition of syncope to the section emphasizes that healthcare providers and consumers should be alert that fainting may occur following vaccination with Gardasil, sometimes resulting in falling and injuries.
  • new information about reports of convulsive syncope, which means fainting associated with seizure-like activity
  • recipients of Gardasil should be observed for 15 minutes after vaccination.  Gardasil recipients should be encouraged to remain seated or lying down for this length of time.

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