To: Food and Drug Administration

Off label use of Cytotec

Urge the FDA to make known the adverse affects of Misoprostol (Cytotec) when used for labor induction.

Why is this important?

The Tatia M. Oden French Memorial Foundation is petitioning the FDA because of adverse events associated with the use of the drug Cytotec, (Misoprostol) for cervical ripening and labor induction. When used to induce labor, Cytotec has been known to cause uterine rupture, AFE and death of the mother and or death of the child.

Tatia Malika Oden French and her daughter, Zorah, are only two of the people who would be alive today had the FDA made the Searle (original manufacturer) announcement available to consumers via its website. They both died because of the amniotic fluid embolism that Tatia experienced, shortly after being administered her second dose of Cytotec on December 27, 2001. That is a fact. If Tatia’s health care provider, an obstetrician, had informed her of the manufacturers warning letter that the doctor’s office received from G.D. Searle, she would never have taken the drug. But her obstetrician chose not to share this information with her.

The August 23, 2000, warning letter from the original manufacturer took an even stronger step and issued a statement sent to 200,000 OBGYN’s throughout the U.S. We quote from this statement:

“Serious adverse events reported following off-label use of Cytotec in pregnant women include maternal or fetal death, uterine hyper-stimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy, amniotic fluid embolism, severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.”

We therefore specifically request the FDA to create a medicine guide, that states these adverse affects of Misoprostol when used off label for labor induction.

If the manufacturer itself warns of death as a possibility for both mother and child, the FDA should make this known.

The FDA, has a duty to publish, at the very least, all of the possible adverse events that have been reported, including those published by the original manufacturer when it is bought by a larger company. By doing this hundreds of mothers and babies lives would be saved.

Category


Reasons for signing

  • Signed consent of Mom with appropriate warnings should be part of her care.
  • Cytotec is currently being used off label here in Australia
  • As a nurse and Childbirth Educator, we need to provide research that medications being used are safe when off label. The United States currently ranks 33 in safe maternal care in developed countries. We need better insight into what contributes to poor maternal infant outcomes.

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