28 Women Miscarry After Receiving HPV Vaccine Gardasil; FDA Says No Reason to Re-Examine Approval

The U.S. Food and Drug Administration said the cervical cancer vaccine Gardasil is safe despite that 28 U.S. women who received the vaccination had miscarriages, CNSnews.com reports.

Clinical trials show the vaccine's miscarriage rate is consistent with that of women in the general population who were given placebos, and most of the miscarriages reported cannot directly be connected to Gardasil, the FDA said.

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A 24-year-old woman miscarried in May after being vaccinated with Gardasil and an investigator reported to the federal government that the miscarriage "may have been caused by Gardasil because the patient received the injection within 30 days of the pregnancy."

The vaccine is used to prevent the human papillomavirus — a sexually transmitted disease believed to be the cause of most cases of cervical cancer.

There have been 3,461 adverse reactions, including eight deaths, reported since the vaccine was approved for use in girls as young as 9 in June 2006. The FDA and U.S. Centers for Disease Control and Prevention have concluded most side effects are minor and believe there is no reason to re-examine the drug's approval.