Gardasil: Information & Warnings

To date, the FDA has not issued a blackbox warning for Gardasil. However, in June 2009, as a response to increasing reports of patients fainting directly after receiving the vaccine, the FDA approved a labeling revision for Gardasil to warn healthcare providers administering the vaccine that patients should remain seated or lying down, and be closely monitored for at least 15 minutes after receiving the vaccination.

The FDA acknowledged that although fainting has been mentioned on Gardasil’s label since 2007, it was requesting that Merck make the warning more prominent in response to continued reports of traumatic injuries suffered by individuals fainting and falling after receiving the Gardasil vaccination. (Read the FDA’s June 2009 announcement here: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm165145.htm).

Adding more uncertainty to the amount of information available to the public regarding Gardasil’s safety, Dr. Diane Harper, the lead researcher involved in the original development of Gardasil, recently announced publicly that there have been no efficacy trials in girls under 15 years of age. This revelation obviously raises serious questions as to whether Gardasil should be given to females under 15. More generally, researchers including Dr. Harper are observing that the potential health risks of taking the vaccine may very well outweigh the benefits, thus questioning whether the vaccine should be administered at all.

If you or a loved one has suffered harm as a result of a Gardasil vaccination, seek legal help immediately to protect your rights. There is no fee and no other obligation, however, if you delay, you may lose your right to seek compensation for injuries caused by Gardasil under the statute of limitations, the state-imposed time limits for filing a lawsuit.

Check out the following articles for more information about Gardasil, filing a Gardasil lawsuit, and finding a Gardasil attorney.