The FDA ( Food and Drug Administration ) has approved a revised label for Gardasil, a vaccine to protect against cervical, vulvar and vaginal cancers caused by human papilloma virus ( HPV ) types 16 and 18 and genital warts caused by HPV types 6 and 11.
In the new label, information pertaining to syncope is now also included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic movements and seizure-like activity.
The addition of syncope to the Warnings and Precautions section emphasizes that healthcare providers and consumers should be alert that fainting may occur following vaccination with Gardasil, sometimes resulting in falling and injuries.
To prevent falls and injuries all vaccine recipients should remain seated or lying down and be closely observed for 15 minutes following vaccination, closely observing them, and watching for the following warning signs and symptoms: paleness, sweating, dizziness, ringing in ears or vision changes, which generally occur before fainting. If an individual faints, and especially if seizure-like activity occurs, the individual should be placed in a position, such as lying down to help restore blood flow to the brain.

FDA has received reports to the Vaccine Adverse Event Reporting System ( VAERS ) of syncope, as well as, syncope with tonic-clonic movements and seizure-like activity that occurred after Gardasil and other vaccinations. Of all of the reports in VAERS pertaining to Gardasil, approximately 13% describe syncope.

The VAERS is a national vaccine safety surveillance program co-sponsored by the FDA and the CDC. The purpose of VAERS is to detect possible signals of adverse events associated with vaccines. VAERS collects and analyzes information from reports of adverse events ( possible side effects ) that occur after the administration of US licensed vaccines.

In 2007, FDA and CDC did a comprehensive review of VAERS reports of syncope and related medical charts after adolescent vaccination. The review found that 30-40% of adolescent syncope reports described signs of jerking or other seizure-like activity, approximately 20% described traumatic injury, and 95% occurred within 15 minutes of vaccination.

Since syncope was added to the label in 2007, FDA continues to receive a consistent number of reports of syncope and traumatic injuries resulting from it. Because the number of reports has not declined, this reminder to healthcare providers emphasizes that preventive measures are warranted. Syncope has been reported after administration of other adolescent and adult vaccines, so it is not unique to Gardasil or even vaccines. Syncope can also occur with certain medications, after blood donation or in response to pain and the following may occur: jerking movements, loss of bladder control, and other signs that resemble epileptic seizures, but is not epilepsy.

Gardasil is a tool for the prevention of cervical, vulvar and vaginal cancers and genital warts HPV types 16 and 18 cause approximately 70 percent of cervical cancers, and HPV types 6 and 11 cause approximately 90 percent of genital warts. According to the National Cancer Institute ( NCI ), in 2009 there will be approximately 11,000 new cases of cervical cancer and 4,000 deaths in the United States.
Gardasil will not treat existing diseases caused by HPV types contained in the vaccine and it is important that vaccination with Gardasil occurs before exposure to HPV infection. Females who receive Gardasil should continue to undergo regular pap tests for cervical cancer screening.

Source: FDA, 2009

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