August 9th, 2009
The labeling for Gardasil has been updated to include more prominent warnings about fainting that can occur following administration of the vaccine. According to the Food & Drug Administration (FDA), some Gardasil fainting victims have suffered from tonic-clonic (jerking) movements and seizure-like activity, and some have fallen resulting in traumatic injuries.
According to a posting yesterday on the FDA website, roughly 13% of Gardasil side effects reported to VAERS describe fainting. In some instances, Gardasil fainting has resulted in serious injuries from falling. Such injuries often occurred while still in the healthcare provider’s office, and other fainting episodes resulted in motor vehicle accidents. Fainting has been listed as a possible side effect on the Gardasil label since 2007, but because of continued reports of this occurrence, the FDA has decided to raise the prominence of this information.
The FDA has asked Merck & Co. to move information on fainting risks to 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 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.
Ggirls and women being injected with Gardasil may be at increased risk of developing the serious Guillain-Barre syndrome (GBS). GBS is a peripheral nervous system disorder linked to some illnesses in the early days following injection.
“… there is clear evidence from our database of an increased incidence of Guillain-Barre syndrome in the first six weeks, especially the first two weeks, after vaccination,” researcher Nizar Souayah, MD, of the University of Medicine and Dentistry of New Jersey in Newark, told Web MD.
A 15-year-old girl’s death finally has the FDA taking another look at Gardasil. Jenny Tetlock died this month after developing a degenerative muscle disease when she was about 13, following a Gardasil injection.
Since, then her parents have been looking into the link between the disease that ultimately claimed their daughter’s life and the vaccination meant to protect her. Jenny likely developed a pediatric form of Lou Gehrig’s disease known as ALS or amyotrophic lateral sclerosis.
Jenny’s parents have reached out to two other sets of parents whose daughters also seem to have been stricken with what seems to be ALS following Gardasil injections. Now, FDA Scientists have met with Jenny’s neurologists and are looking into the possibility of a vaccine prompting ALS.
The CDC plans on reviewing its adverse-event database—VAERS—for cases in which nonGardasil injections led to ALS or other neurological problems.