Gardasil: Vaccine's Safety Challenged

Special Alert: July 2008

Gardasil Linked to Adverse Side Effects

Since Gardasil's introduction in 2006, the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) have received almost 8,000 reports of adverse side effects in girls and women who received the vaccine. The reported adverse effects include 15 deaths and 31 instances of Guillain-Barre syndrome, a potentially paralyzing, life-threatening condition in which the body's immune system attacks the nervous system.

Gardasil's link to these side effects has not yet been established. The CDC says it has been unable to determine what role Gardasil played in 10 of the reported deaths; patient information was not available for the other five.

What is Gardasil?

Gardasil is the first cervical cancer vaccine. It targets four strains of the human papillomavirus (HPV), which are linked to many, but not all, cervical cancers and genital warts. The vaccine is administered in three doses over a six-month period. Gardasil is manufactured by Merck & Co, and was approved in June 2006 for girls and women ages nine to 26.

Since its approval, over 26 million doses of the vaccine have been given worldwide, with 16 million in the United States.

Possible Side Effects of Receiving the Gardasil Vaccine

Seek immediate medical attention if you develop any of the following symptoms of an allergic reaction to Gardasil:

• Hives
• Difficulty breathing
• Swelling of the tongue, lips, face, or throat

Other serious side effects may include:

• Feeling faint or dizzy
• Pain, itching, or redness at the injection site
• Mild fever
• Nausea, vomiting, diarrhea, or upset stomach
• Runny or stuffy nose
• Sore throat
• Cough

Overview of Gardasil

Gardasil has been under scrutiny after news headlines featured reports of serious, sometimes fatal, side effects in patients who received the vaccination.

In January 2008, Pfizer updated the Chantix drug label to include a more prominent warning about its side effects of agitation and suicidality. Shortly thereafter in February 2008, the FDA confirmed a strong link between Chantix and suicidal behavior, noting the drug’s connection to nearly 40 suicide reports and over 400 instances of suicidal activity.

Reseach that led to the development of the vaccine began in the 1980s, and the active ingredients of the vaccine were generated in 1993. Clinical trials of Gardasil were conducted on 12,000 women ages 16 to 26. Gardasil was tested on only a few hundred 11- and 12-year-old girls.

The long-term impact of the vaccine is not known. Because testing of Gardasil lasted only a few years, it is unclear how long it remains effective. Furthermore, since most recipients of the vaccine will not reach an age at which they are more likely to develop cervical cancer for quite some time, the real-world effectiveness of Gardasil remains unproven.

You Need Experienced Lawyers Who Understand Dangerous Drug Cases to Fight On Your Side

If you or a loved one has been hurt due to receiving the Gardasil vaccination, you need to act quickly. When our drug injury attorneys and staff get involved with your case, we immediately get to work investigating the cause of your drug reaction and fighting for your legal rights to fair compensation.