Gardasil Increases Risks of Potentially Fatal Blood Clots, New Study Finds

Millions of American girls and young women who have received the vaccine Gardasil to ward off the most common causes of cervical cancer are at increased risk of developing possibly deadly blood clots and other severe complications, new research has found.

Other serious health complications associated with Gardasil include fainting episodes, severe allergic reactions, and Guillain-Barre syndrome (GBS), a rare but potentially deadly condition in which the body’s immune system attacks the nervous system.

At least 20 deaths and two cases of Lou Gehrig’s disease also have been reported in Gardasil patients, but researchers who published their findings in The Journal of the American Medical Association cautioned there is no way to prove the complications were actually caused by the vaccine.

FDA and CDC Led Research

The research team led by the Centers for Disease Control and Prevention and Food and Drug Administration said the benefits of Gardasil still outweigh the risks and that they still recommend women to get the vaccine, which guards against some, but not all, forms of the human Papillomavirus (HPV).

The vaccine is approved for girls and young women between the ages of nine to 26 and is recommended for routine vaccination of girls who are 11 and 12.

Merck officials say Gardasil is no more dangerous than similar vaccines, but some critics say giving a vaccine to millions of healthy girls and women to prevent a disease that can effectively be detected by screening is a mistake.

Thousands of Reports Analyzed

The study focused on 12,424 reports of adverse events that occurred after immunization with Gardasil from June 1, 2006, to Dec. 31, 2008. During that time, more than 23 million doses of the vaccine were distributed. A vaccination of Gardasil requires three separate shots of the vaccine.

About six percent of all adverse event reports, a total of 772, were deemed serious events, including 32 deaths. There were two cases of diabetic ketoacidosis, one case related to prescription drug abuse, one case of juvenile amyotrophic lateral sclerosis or Lou Gehrig’s disease, one case of meningoencephalitis, three pulmonary embolisms or blood clots to the lung, six cardiac-related deaths, one case of sepsis related to influenza B and two because of seizure disorders. Four deaths were unexplained, according to the JAMA publication.

Fainting was the most common side effect, with about eight episodes reported for every 100,000 doses, followed by local site reactions (7.5 per 100,000 doses) and dizziness (6.8 per 100,000 doses).

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