Cytotec and the FDA
by Ina May Gaskin

[Editor’s note: This is an excerpt of an article which appears in Midwifery Today, Issue 107, Autumn 2013. View other great articles and columns in the table of contents. To read the rest of this article, order your copy of Midwifery Today, Issue 107.]

First, a little background information regarding drug safety.

The Food and Drug Administration (FDA) describes its role as serving as a regulatory agency by publishing rules that establish or modify the way it regulates foods, drugs, biologics, cosmetics, radiation-emitting electronic products and medical devices. Much of the prestige that agency still enjoys worldwide stems from the work of Dr. Frances Kelsey, who was a compliance officer at the FDA in the early 1960s. She became an international hero when she withstood great pressure by a prominent German drug company that wanted quick approval for the drug thalidomide to be used for insomnia and morning sickness in pregnant women in the US. The manufacturer insisted that it would be safe for use, pointing out that 20 other countries had already approved the drug. Demanding more testing on the proposed use for pregnant women before she would consider approval, Dr. Kelsey’s insistence on scientific rigor saved countless women in the US from giving birth to children afflicted by phocomelia (missing limbs and other major malformations). Her stubborn stand was vindicated when thousands of babies were born with phocomelia in countries where thalidomide was approved. This tragic development led to the passage of laws by Congress which attempted to strengthen the FDA’s control of drug experimentation on humans and the way new drugs are regulated.

However, now we come to a problem that Dr. Kelsey’s important work did not reach: the practice of prescribing drugs for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration—what is called “off-label use.” Contrary to popular notion, it is legal in the US and in many other countries to use drugs off-label. What most people (including many midwives) may not know is that with the exception of oxytocin and Cervidil, almost all drugs used in obstetrics are prescribed off-label, primarily because there is little or no incentive for a drug company to make an application for a drug intended for pregnant women. This doesn’t mean that there will be no experimentation of drugs on pregnant women. It more likely means that women often won’t be aware that the drug prescribed for them is experimental in nature and that if a drug turns out to have some harmful side effects, these may be very difficult for the public to learn about.

The Story of Two Drugs and Their Obstetric Use

Keeping this background information in mind, it is interesting to compare the medical profession’s and the FDA’s treatment of terbutaline sulfate to stop preterm labor with their treatment of the drug Cytotec (misoprostol) for making labor start or for use with cervical ripening. Both drugs have been used off-label in obstetrics, with terbutaline sulfate having been approved for the treatment of asthma and Cytotec (misoprostol) having been approved to prevent ulcers.

Throughout the 1990s, many studies about both drugs were published in the obstetrical literature. Leading obstetricians, particularly in the US, were clearly interested in gaining the power to stop and start labor at will, with the stated goal of reducing or eliminating fetal deaths related to pre- or postterm labor. During this period, millions of women were given these drugs, many of them without being informed that they and their babies were subjects of experiments in new, possibly risky therapies.

The first dark cloud that appeared over the use of terbutaline sulfate came in 1993, with the publication of a case report of a maternal death attributed to terbutaline (Hudgens and Conradi 1993). The report described a 34-year-old previously healthy first-time mother, pregnant with twins, who began to be treated with terbutaline at 25 weeks. A week after the therapy was begun, first in hospital and then continued with a subcutaneous infusion pump at home, her husband found her unresponsive in her bed still attached to the pump. She had been dead for some time. The paper’s author remarked that this case hadn’t been the first maternal death associated with the drug—just the first one that had taken place at home.


Reference:

  • Hudgens, D, and S Conradi. 1993. “Sudden Death Associated with Terbutaline Sulfate Administration.” Am J Obstet Gynecol 1 (69): 120–21.

Ina May Gaskin is the founder and director of The Farm Midwifery Center in Tennessee. She is the author of Spiritual Midwifery (1975) and Ina May’s Guide to Childbirth (2003). She was president of MANA from 1996–2002, and is a prominent national and international speaker. She has been a homebirth midwife since 1971.


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