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FDA Strengthens Warnings on Gardasil

-WSJ

06/11/2009 - The Food and Drug Administration on Wednesday strengthened warnings on Merck & Co.'s Gardasil vaccine about fainting after receiving reports of "traumatic injuries" among some vaccine recipients.

In a posting aimed at health-care professionals posted on 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.

If you or a loved one have experienced serious side effects as a result of the Gardasil HPV vaccination such as blood clots, paralysis, seizures, or other Gardasil side effects, you may be entitled to compensation. Pregnant women who suffered a miscarriage or fetal abnormalities following the administration of Gardasil, should contact one of our Gardasil side effect lawyers in order to protect your rights. For more information about a potential Gardasil lawsuit, or Gardasil side effects, fill out our free case evaluation form or call the toll-free number listed below today.