Gardasil’s Benefits Outweigh Risks
After reviewing thousands of reported health problems, U.S. Food and Drug Administration officials announced on Tuesday that Merck & Co’s vaccine Gardasil is safe for women.
The vaccine is touted to be effective in protecting women and girls from human papillomavirus (HPV), which is linked to cervical cancer.
The agencies announced the vaccine was safe and effective after reportedly reviewing more than 9,700 reports of human problems following Gardasil injections.
"Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks," a statement said.
Many complaints came from both consumers and doctors about Gardasil’s safety, but officials from the FDA and Centers for Disease Control and Prevention said the most serious adverse reactions were not linked to the injections.
Six percent of the cases were deemed serious events. They included 20 deaths reported as of June 30.
"There was not a common pattern to the deaths that would suggest they were caused by the vaccine," the FDA and CDC statement said.
In cases where autopsy or other records were available, "the cause of death was explained by factors other than the vaccine," the agencies said.
Some claimed that Gardasil lead to the onset of a rare serious neurological disorder called Guillain-Barre Syndrome.
But data "do not currently suggest an association" between Gardasil and the condition, the FDA and CDC said.
The vaccine is one of Merck’s top-selling products but its sales have been under pressure. On Monday, Merck projected 2008 Gardasil sales of between $1.4 billion and $1.6 billion. That was down from its prior view of $1.9 billion to $2.1 billion.
The lowered forecast was due in part to Merck’s failure earlier this year to win U.S. approval to market the vaccine to an older group of women.
Merck has distributed more than 16 million Gardasil doses in the United States.
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