HealthDay News reports the drug is designed to block infection by four types of HPV that cause more cervical cancers and genital warts.
The FDA briefing documents show that Gardasil may cause a rise in the number of cases of a cancer precursor among people who are already infected by one of the four HPV types. It may also increase cases in patients whose immune systems still have remnants of the virus in their bodies.
The FDA papers request an expert panel to examine the five cases where women who were treated with the vaccine gave birth to children with birth defects. An outside panel of experts will decide whether to recommend the use of Gardasil.
The FDA's decision is expected by June 8. HPV is the most common sexually transmitted disease among women ages 9 to 26.
