Cytotec

Your article on Cytotec, "Induced and Seduced" by Ina May Gaskin (July-August 2001), knocked me for a loop. I felt as if I were reading a story about my experience two years ago. All this time, I thought my post-delivery tragedy was a fluke ... an aberration on the map of possibilities.

I was a healthy 30 year old going in to have my second child. My first pregnancy ended with a dose of Pitocin, a beautiful daughter, and a healthy me. Not this time. Soon after giving birth, I felt myself being wheeled into emergency surgery. I had lost half of my blood and my uterus. I went into shock, and I stayed in the ICU for the better part of a week. No one on the medical staff could explain why all of this had happened to me. I felt that my body had betrayed me.

In hindsight, my husband recalls questioning the birthing nurse after she administered Cytotec on my cervix to induce labor. The nurse left the wrapper on the bedside table, and my husband read that the pill was not to be used on pregnant women. When questioned, she basically dismissed the labeling as hogwash. "We use it all the time as a substitute for Pitocin ... it's perfectly safe," she went on.

Not until I read this article did I put it together. Saving death, every bad thing that can accompany this drug happened to me. I encourage others who have suffered the ill effects of this misused drug to come forward, and I urge those who are pregnant to refuse it. We must bring out the truth about this medication. Cytotec is still being used at many hospitals, including the one that gave it to me.

I was thrilled to see the Cytotec article. I found it ironic, however, to find it included in an issue profiling "25 Great Freestanding Birth Centers" (Bulletins, July-August 2001). I gave birth to my third child at one of the birth centers listed in this article. At a postpartum support group for mothers who gave birth at this facility, I was shocked to find that 9 of the 11 women in the room either had been induced with Cytotec or had been manually dilated during labor, or both.

I am writing to correct an omission in the article "Induced and Seduced" by Ina May Gaskin.

Prior to June 2000, the prescribing label for Cytotec stated, "Cytotec must not be used by pregnant women. Cytotec may cause miscarriage ..."

Searle, the manufacturer of Cytotec, requested and received a label change in June 2000 from the FDA. The new label states: "Because of its abortifacient property, Cytotec is contraindicated for use by pregnant women. Cytotec may cause miscarriage if given to pregnant women at any time during pregnancy ..."

In addition, Searle added two paragraphs specifically relating to uterine rupture. The paragraph relating to labor states: "Uterine rupture has been reported when Cytotec was administered intravaginally in pregnant women to induce labor or to induce abortion beyond the first trimester of pregnancy."

Yet another sentence was added to the label under adverse reactions related to uterine rupture: "There have been reports in which intravaginal administration of misoprostol in pregnant women resulted in rupture of the uterus and death of the infant."

When providers' use of Cytotec continued to be contraindicated after the June 2000 label change, Searle sent an August 2000 letter directly to providers. This action resulted in the ACOG (American College of Obstetricians and Gynecologists) petition described by Ina May Gaskin in her article: "On November 1,2000, ACOG submitted what is called a `citizen petition' to the FDA requesting that the agency require Searle to withdraw its letter warning of Cytotec's potential dangers when used for labor induction."

As Gaskin writes, ACOG has requested that the FDA require Searle to withdraw its letter of warning. But Gaskin left out an important point: ACOG has also asked the FDA to rescind the label change stating that the use of cytotec/misoprostol is contraindicated in pregnancy.

The removal of the contraindicated statement from the prescribing label of Cytotec is actually the aspect that will affect patients. With such a strong statement on the prescribing information, every person who takes Cytotec must be told that the FDA has stated that the use of Cytotec is contraindicated in pregnant women. Doctors who don't make this statement would be violating a patient's right to informed consent. If the label remains as it is, every provider who wishes to use Cytotec on a woman has the responsibility to inform the woman of the FDA-listed complication rates and contraindications.

This is the focus of the ACOG petition. A letter to providers does not affect a patient's right to information. A statement by the FDA on the prescribing label does.

As an added note, all information available to physicians on any drug can be found in the Physicians' Desk Reference. You can find a copy at your local library or at your pharmacy.

COPYRIGHT 2001 Mothering Magazine
COPYRIGHT 2003 Gale Group