FDA strengthens labeling for HPV vaccine

The FDA has is urging physicians to administer Merck’s Gardasil vaccine while a patient is seated or lying down and is asking that patients be observed for 15 minutes following vaccination. This newly revised recommendation comes after the FDA received reports of fainting among vaccine recipients.

The agency has required mention of fainting in Gardasil’s labeling since October 2007, but the agency opted to strengthen the labeling and move it to a more prominent place in light of some reports of patients fainting and sustaining serious injuries from falling. Some of the fainting episodes were seen while patients were still in their physician’s office but others included car accidents.

FDA officials also said there have been reports of tonic-clonic and seizure-like movements after the vaccine is administered.

The FDA said fainting is common in many vaccines, and is not unique to Gardasil. According to the Vaccine Adverse Event Reporting System database, 13% of Gardasil-related adverse event reports describe fainting.