FDA: Stronger Warning for HPV Vaccine

According to the Oncology Nursing News, the information pertaining to syncope in the “Warnings and Precautions” section of the label for Gardasil has been modified and strengthened by Merck & Co. at the request of the FDA.

The Gardasil vaccine is designed to protect against cervical, vulvar, and vaginal cancers caused by human papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11. Syncope has been in Gardasil’s labeling for healthcare providers and patients alike since October 2007, but both the FDA and the Centers for Disease Control and Prevention continue to receive reports of serious injuries resulting from people fainting and falling or having car accidents after being vaccinated.

(Syncope is not unique to Gardasil; the problem has been reported after administration of other adolescent and adult vaccines as well.)

The FDA asked Merck to revise the syncope information so that it is more prominent and reminds healthcare providers to be alert to the fact that fainting may occur following vaccination with Gardasil, sometimes resulting in falls and injuries.

To prevent such incidences, the label includes a recommendation that all recipients remain seated or lying down and be closely observed for the first 15 minutes after getting vaccinated. The FDA-approved label revision also notes that individuals who faint sometimes have tonic-clonic movements and seizure-like activity.

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