Label Changes for:
Gardasil (Human Papillomavirus Quadrivalent Types 6, 11, 16, 18) Recombinant Vaccine
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.