FDAnews Drug Daily Bulletin

Gardasil Adverse Events Include Deaths, Seizures, Judicial Watch Says

Oct. 11, 2007
A A

There have been 3,461 reports of adverse events, including a maximum of 11 deaths, in patients receiving Merck’s cervical cancer vaccine Gardasil, public interest group Judicial Watch said.

Since May, the group has found documents detailing 1,824 reports of adverse reactions to Gardasil (quadrivalent human papillomavirus [Types 6, 11, 16, 18] recombinant vaccine), including eight deaths. Before May, Judicial Watch had obtained 1,637 adverse event reports. The group received the data from the FDA through a Freedom of Information Act (FOIA) request.

Of the 1,824 adverse events reported between May 10 and Sept. 7, 347 were serious reactions including paralysis, Bell’s palsy, Guillain-Barre syndrome and seizures, according to the group.

Thirty-three out of 77 pregnant women who received the vaccine experienced side effects, including spontaneous abortion and fetal abnormalities, Judicial Watch added.

“In light of this information, it is disturbing that state and local governments might mandate in any way this vaccine for young girls,” Judicial Watch President Tom Fitton said.