FDA expand Gardasil Warnings

March 27th, 2009 by Jennifer

http://www.washingtontimes.com/news/2008/jul/10/merck-fda-expand-gardasil-warnings/

Merck, FDA expand Gardasil warnings  Amy Fagan (Contact)

Thursday, July 10, 2008

Merck & Co. and the Food and Drug Administration in June expanded the possible adverse reactions for Gardasil,
the widely advertised cervical cancer vaccine for girls and young
women, to include joint and muscle pain, fatigue, physical weakness and
general malaise.

The new warning - added to the package insert and to an information
sheet given to patients - was approved June 12 by the FDA, which states
in documents on its Web site that the updated information "reflect
reports received" after the vaccine went on the market in 2006.

Through June 10, medical professionals and others reported to a
government database 8,864 instances of health problems, including
fainting, numbness, seizures and paralysis, a study released June 30 by
the conservative watchdog group Judicial Watch shows. The database is
shared by the FDA and the Centers for Disease Control and Prevention.
As many as 18 deaths were reported, the study found.

FDA spokeswoman Karen Riley said the updates have "nothing to do
with" the serious cases that have been reported. She said the updates
were made at Merck's request and touch on possible "mild" symptoms.

"The bottom line is that we have not seen any safety signals in the
adverse events other than [fainting]," she said. "We continue to look
at these reports."

Merck spokeswoman Amy Rose said Wednesday she didn't have any
conclusive answers about the recent changes but that she doesn't "have
any reason to believe it was anything other than a routine update."

The vaccine, typically given in three doses, is approved for females
ages 9 to 26. It targets certain kinds of a sexually transmitted virus
known to cause cervical cancer.

One case involves a 13-year-old from Berkeley, Calif., who got her
third shot of Gardasil in March 2007. Later that spring, she began
feeling weak and today she is paralyzed, according to her family's
blog.

Officials at FDA, Merck and the CDC say the vaccine is safe and effective.

CDC spokesman Curtis Allen said government and Merck officials scour
all reports of adverse health events and look for patterns, such as
higher rates of certain health incidents than one would see among girls
who didn't get the vaccine.

"From the data we have seen to date, the vaccine is safe and effective," he said, adding that his daughter received it.

He said the CDC only knows of 17 deaths and that he didn't know why
Judicial Watch cited one other death. He said that among the 17
reported deaths from April 2007 to June 30, the government has
determined eight are not linked to Gardasil, three are under review and
the rest were inconclusive.

Merck on Tuesday said it analyzed the reports of death and paralysis
and thinks "no safety issue related to the vaccine has been
identified." It also said it continues to evaluate all safety
information. "The vast majority of adverse events that have been
reported to Merck are non-serious," it said.

Gardasil was tested on more than 11,000 girls and women before its
approval. Since then, 16 million doses of the vaccine have been
distributed in the U.S., according to Merck.

Some think it deserves a serious second look.

"I think we've uncovered a lot of disturbing things about Gardasil,"
said Tom Fitton, president of Judicial Watch. "All we're asking for is
further investigation of its safety. ... We're not convinced they're
taking these reports seriously."

Neither is Doug Davison, of Frederick, Md., whose 20-year-old
daughter Mary Katherine suffered a stroke last winter about 20 days
after getting her second shot. He isn't sure there's a connection but
he has some questions.

"I'd like to know if [the vaccine] is something that's being looked
at as a possible cause," he said. "Is the government really seriously
looking into it as a problem?"

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