FDA Orders Stronger Warning Label for Gardasil

Gardasil, the vaccine given to millions of younger women and girls around the world to protect against cervical cancer, must carry stronger warnings about the risk of fainting spells after receiving the shots, the Food and Drug Administration has ruled.

The FDA has received reports of “traumatic injuries” among some people who received the Gardasil vaccine, prompting the order for stronger warnings on the product’s packaging. The FDA also advised that people receiving the vaccine should be closely observed and remain sitting or lying down for 15 minutes after receiving the vaccine to avoid injuries from falls resulting from fainting.

The risk of fainting after receiving the shot has been included in Gardasil’s labeling since October 2007, the FDA said. But now drug-safety officials have ordered stronger and more prominent warnings about the risk be added to Gardsil’s packaging to further caution physicians and patients of the risk.

Gardasil, the Merck & Co. vaccine approved in 2006, guards against four common strains of the human papillomavirus (HPV), which accounts for most cases of cervical cancer. The shots are recommended for women and girls as young as 11.

The vaccine has been controversial and linked to severe injuries and adverse allergic reactions in women and girls.

In April 2008, medical researchers said people taking Gardasil to prevent cervical cancer appeared to be more at risk of developing a rare but severe nervous system disorder called Guillain-Barre syndrome. The condition typically is triggered by an infection such as influenza, but a study found women receiving Gardasil were more likely to develop weakness, paralysis, and numbness and tingling of the limbs associated with Guillian-Barre syndrome.

In February 2009, about 76,000 doses of Gardasil were recalled in Spain after two girls there were hospitalized after developing severe adverse reactions to the vaccine. A 2008 study in Australia reported at least three severe allergic reactions to the drug among girls and young women there.

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