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Gardasil Fainting Warning Upgraded

Gardasil’s fainting warning is more prominently warns that fainting can occur following administration of the vaccine. The FDA reports some Gardasil fainting victims have suffered from jerking movements and other seizure-like activity. Additionally, some have had severe injuries from falling.

Gardasil, manufactured by Merck & Co. of New Jersey, was approved by the FDA in June 2006.At the time of its approval, Merck & Co. said clinical trials had shown the drug to be between 90-100 percent effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. The U.S. Centers for Disease Control and Prevention (CDC) recommends that all young girls age of 11 and 12 receive the Gardasil vaccine. Gardasil is approved for females age 9 to 26.

Gardasil has been controversial because Merck & Co. has attempted to make it mandatory and because of lingering questions about its safety. From June 2006 through January 2009, 9,749 adverse reactions have been reported. Twenty-one of the reports were deaths. Additional side effects include: 10 miscarriages, 78 severe outbreaks of genital warts, and 6 cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis. Side effects were reported to the FDA and CDC via the Vaccine Adverse Event Reporting System (VAERS).

The FDA reports approximately 13% of Gardasil side effects reported to VAERS describe fainting. Fainting is a common side effect associated with vaccines. Fainting often occurred while still in the healthcare provider’s office, and other fainting episodes resulted in motor vehicle accidents. Though the fainting side effect has been on the label since 2007, the prominence of the warning is being increased because of continued fainting reports.

The FDA has asked Merck & Co. to list fainting risks under the “Warnings and Precautions” section of the Gardasil label. The revised label reminds healthcare providers that recipients of Gardasil should be closely observed for 15 minutes after vaccination. Gardasil recipients should remain seated or lying down for this length of time and be alert to the following warning signs and symptoms that may happen before a person faints: paleness, sweating, dizziness, ringing in ears or vision changes.

Any adverse reports associated with Gardasil should be reported to the FDA.

The FDA can be contacted via:
Online at
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

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