Merck, FDA expand Gardasil warnings

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.

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