FDA Issues Final Analysis on Potential VTE-Gardasil Link

FDA Issues Final Analysis on Potential VTE-Gardasil Link
FDA Issues Final Analysis on Potential VTE-Gardasil Link

A final analysis by the Food and Drug Administration (FDA) has found no association between venous thromboembolism (VTE) and Gardasil (quadrivalent human papillomavirus types, recombinant; Merck) vaccination.

This review was in response to a 2010 comprehensive postlicensure safety evaluation of Gardasil in which inclusive data led the FDA to conduct a follow-up study. The Sentinel study, the largest study of VTE cases following immunization with Gardasil in the United States, evaluated VTE risk in over 650,000 females aged 9–26 receiving a total of 1.4 million doses of Gardasil. Only 30 confirmed cases of VTE were identified in the 8–9 week observation period after each dose administered in the 3–dose series from 2006–2013. When the risk of VTE one to 28 days following Gardasil vaccination was compared to VTE risk approximately one to two months after vaccination, no evidence was identified of an increased risk in the one to 28 day period after any of the three Gardasil doses. After scanning the entire eight to nine week observation period, no unusual VTE clusters appeared after Gardasil vaccination which strengthens the conclusion of no increased risk of VTE after immunization.

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Gardasil is indicated in females 9–26 years old, to prevent cervical, vulvar, vaginal and anal cancer caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; cervical adenocarcinoma in situ (AIS) and cervical intraepithelial neoplasia (CIN) grades 2 and 3, vulvar intraepithelial neoplasia (VIN) grades 2 and 3, vaginal intraepithelial neoplasia (VaIN) grades 2 and 3, cervical intraepithelial neoplasia (CIN) grade 1, and anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types 6, 11, 16, and 18. In males 9–26 years old, to prevent anal cancer caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types 6, 11, 16, and 18.

For more information call (888) 463-6332 or visit FDA.gov.

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