FDA Reports"Traumatic Injuries" Among Some Gardasil Vaccine Recipients

FDA Strengthens Fainting Warnings On Gardasil’s Label

WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration on Wednesday strengthened warnings on Merck & Co.’s (MRK) Gardasil vaccine about fainting after receiving reports of “traumatic injuries” among some vaccine recipients.

In a posting aimed at health-care professionals posted to the agency’s Web site, the FDA said all vaccine recipients should remain seated or lying down and be closely observed for 15 minutes following vaccination “to prevent falls and injuries.”

Gardasil was approved in June 2006 and is designed to protect against four strains of the human papillomavirus, or HPV, two of which account for about 70% of cervical-cancer cases. It’s recommended that girls ages 11 to 12 receive the vaccine in a three-dose series before they are sexually active, and it coincides with recommendations on other vaccines.

The FDA said that since October 2007 a discussion about fainting has been in Gardasil’s labeling for both the health-care provider and the patient. However, warnings about fainting have been strengthened and moved to a more prominent place on the drug label and on information that is supposed to be given to patients before they are vaccinated. The new materials were approved by the agency Wednesday.

The FDA said that individuals who faint sometimes have jerking movements and seizure-like activity but it doesn’t mean a person is having a seizure.

The agency also said some patients who fainted had serious injuries from falling. Some injuries were seen while patients were still in the doctor’s office while others resulted in car accidents.

The FDA said fainting has been reported after administration of other types of adolescent and adult vaccines. It said it’s considering whether to strengthen fainting warnings on other vaccines.

The agency said that in an adverse-event database that tracks vaccine safety, 13% of Gardasil-related reports describe fainting.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

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Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.