Personal Injury Law

HPV Vaccine Gardasil Must Warn Of Fainting

By Jane Akre

Gardasil Warning Upgraded

The Merck drug featured in the "One Less" campaign has been updated to receive a warning about the potential for fainting.

Gardasil will feature a more prominent warning after the Food and Drug Administration (FDA) determined some young teens have suffered jerking movements and seizures after being inoculated.

13 percent of Gardasil side effects include fainting that can result in serious injury from the fall.  The Gardasil label now must now list under the "Warnings and Precautions" section, more information about the risk of fainting.  Those receiving the inoculation should be closely watched for 15 minutes afterward.

Young women are warned to watch for dizziness, ringing in the ears, vision changes, or sweating. It is recommended recipients stay seated or lie down for 15 minutes.

Background

Gardasil just passed its third year anniversary of FDA approval. It was approved to protect girls from ages 11 to 26 against four types of HPV, Human Papillomavirus -  two that cause cervical warts and two viruses that cause cervical cancer.  It is only effective if the person has not previously been infected. 

Most women contract at least one strain of HPV by the age of 50 without complications. Merck has tried to receive, but has been denied approval for use in older women. 

Merck launched an aggressive campaign to have the vaccine made mandatory, working through women in state legislatures.  Three scholars told the Wall Street Journal last year that the vaccines should not be made mandatory. 

Not without controversy, Gardasil has been linked to 13,758 adverse reports and at least 39 deaths since 2006.

Other adverse reports include six cases of Guillain-Barre Syndrome (GBS), an autoimmune disorder that causes muscle weakness, 10 miscarriages, and 78 outbreaks of genital warts. 

The serious reports include hospitalization, permanent disability, life-threatening illness, blood clots, and death.  Experts have not found any common pattern to link the adverse events to Gardasil. 

The FDA tracks the reports on its VAERS Web site (Vaccine Adverse Event Reporting System).  

Judicial Watch, a Washington D.C. - based court watching nonprofit, periodically petitions the FDA with a freedom of information request to find under-reported adverse reports.  

Adverse reports since 2008 include: a 20-year-old female who died four days after her vaccination; a 23-year-old female who went into anaphylactic shock two minutes after vaccination; and a 14-year-old who broke into a cold sweat, convulsions and was foaming at the mouth after her dose. 

On June 10, 2008, Judicial Watch received a compact disk from the FDA with a new total of 8,864 Vaccine Adverse Event Reporting System (VAERS) records. These documents and the new Judicial Watch report, entitled "Examining the FDA's HPV Vaccine Records: Detailing the Approval Process, Side-Effects, Safety Concerns & Marketing Practices of a Large Scale Health Experiment."

The CDC continues to recommend Gardasil to prevent four types of HPV and says it will continue to monitor the vaccine's safety. #

Full post as published by InjuryBoard on June 11, 2009 (boomark / email).