Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
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Washington Times (07.10.08) - Thursday, July 10, 2008
Amy Fagan
On its Web site, FDA said the updated warnings "reflect reports received" after the vaccine came to market in 2006. The revised notice says females receiving the injections may experience joint and muscle pain, fatigue, physical weakness, and general malaise.
Karen Riley, a spokesperson for FDA, said the updated language has "nothing to do with" the reports of serious side effects related to the vaccine. Rather, she said, the updates were made upon Merck's request and deal with possible mild symptoms. "The bottom line is that we have not seen any safety signals in the adverse events other than [fainting]. We continue to look at these reports."
On June 30, the conservative group Judicial Watch released a study saying that a government database had collected 8,864 cases of Gardasil-related health problems including fainting, numbness, seizures, paralysis, and as many as 18 deaths.
Amy Rose, a spokesperson for Merck, said she lacked conclusive answers about the recent changes but has no "reason to believe it was anything other than a routine update."
Government and Merck officials study all reports of adverse events linked to Gardasil, and, "from the data we have seen to date, the vaccine is safe and effective," said Curtis Allen, a spokesperson for CDC who said his own daughter has been vaccinated with Gardasil.
While Judicial Watch cited 18 deaths, Allen said CDC knows of only 17. Of these, he said, the government has determined that eight were unrelated to Gardasil; three are under review; and the rest were inconclusive.
Officials at FDA, Merck, and CDC maintain the vaccine is safe and effective.
To read the updated packaging information for Gardasil, visit http://www.fda.gov/cber/label/gardasilLB.pdf.
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