Gardasil
If you have suffered a personl injury as a result of the dangerous drug Gardasil, you may be eligble for compensation and should contact an attorney who specializes in product liability litigation and dangerous drug litigation against pharmaceutical companies.
Gardasil revised label notification from FDA
On June 9, 2009, the Food and Drug Administration (FDA) approved a revised label for Gardasil, a vaccine to protect against cervical, vulvar and vaginal cancers caused by Human Papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11. In the new label, information pertaining to syncope (fainting) 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 (jerking) 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.
As with all vaccines, FDA closely monitors the safety of Gardasil. Syncope (fainting) has been in Gardasil's labeling for both the healthcare provider and the patient since October 2007; however, FDA and the Centers for Disease Control and Prevention (CDC) continue to receive reports of traumatic injuries of individuals fainting and falling after receiving Gardasil. Some who fainted have had serious injuries from falling, which have often occurred while still in the healthcare provider's office, and other fainting episodes resulted in motor vehicle accidents. Therefore, FDA requested the manufacturer, Merck and Co., Inc., to add this information to the Warnings and Precautions section of the label, so that it is more prominent, and reminds healthcare providers that recipients of Gardasil should be closely observed for 15 minutes after vaccination. Gardasil recipients should be encouraged to 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.
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. Jerking movements, loss of bladder control, and other signs that resemble epileptic seizures may occur with fainting, but do not mean that the person is having epilepsy. New information in the Warnings and Precautions section alerts healthcare providers that tonic-clonic (jerking) movements and seizure-like activity can occur with fainting. Syncope and its associated signs and symptoms generally last only a short time (seconds to minutes) and resolve when the patient is placed in a position, such as lying down, to restore adequate blood flow to the brain.
Gardasil Findings
Healthcare providers and consumers should be aware that syncope (fainting) may occur following vaccination with Gardasil, sometimes resulting in falling and traumatic injuries. These falls and injuries are preventable by having Gardasil recipients remain seated or lying down 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 (jerking) 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 percentage is similar to reports of syncope for other adolescent vaccines.
