CDC, FDA reiterate Gardasil safety

7/23/2008

WASHINGTON The Centers for Disease Control and Prevention and the Food and Drug Administration announced Tuesday that Merck’s Gardasil is a safe and effective protection against human papillomavirus.

The CDC’s and FDA’s announcements followed almost 10,000 reports of bad reactions in patients who received injections of Gardasil. Six percent of the reactions were considered serious and included 20 deaths reported up to June 30, but the agencies failed to find a pattern that suggested the deaths resulted from the vaccine.

Human papillomavirus causes genital warts, as well as cervical cancer in women. Gardasil (human papillomavirus quadrivalent vaccine, recombinant) had sales of $1.5 billion last year, according to Merck financial data.

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