test the drugsâ safety for labor induction. In other words, it is cheap because we donât know whether itâs safe, and it is women on whom it is used who are paying the price. Of course, hospitals love to save money, but they must also realize that they are taking a huge financial risk when Cytotec is used to induce labor because they may well lose much more in litigation after a single bad outcome than they can save in years of using the cheaper drug.
In 1998, after Cytotec had been used for induction on millions of women in the United States, a paper was published about an experimental trial in which the drug was used for labor induction in women who had previously had C-sections who were having vaginal births after cesarean (VBACs). The study had to be stopped midway because too many women attempting VBACs with Cytotec induction ended up with ruptured uteruses, a catastrophic obstetric emergency that almost always means that the woman will not be able to have more children and that has a high risk of mortality for both the woman and the baby. 13 When the paper was published, I called ACOG and asked if the organization was aware of the sweeping use of Cytotec for induction. They replied that, yes, of course they were aware of it. I then asked why they were not doing anything about it. They replied that since it was off-label use and they had no position on off-label use, they were not prepared to take any position (thus turning their backs on this serious obstetric issue).
TABLE 5. CYTOTEC INDUCTION IN THE UNITED STATES, 1994â99
Total Cytotec induction in United States, 1994â99
Births per year (CDC)
4,000,000
On average, 15 percent are induced each year (CDC)
600,000
25 percent of inductions use Cytotec each year (ACOG)
150,000
Total Cytotec inductions in five years
750,000
Cytotec inductions with previous cesarean section in the United States, 1994â99
*
Out of 4,000,000 births each year (CDC):
15 percent with previous C-sections (CDC)
600,000
25 percent try VBAC (ACOG)
150,000
on average, 7 percent of VBACs are induced (CDC)
10,500
(VBAC induction rate is assumed to be half the overall induction rate)
25 percent of VBAC inductions use Cytotec (ACOG)
2,625
4 percent of VBAC Cytotec inductions rupture (P&B)
105
25 percent of uterine ruptures result in babyâs death (P&B)
26
Over the five-year period (1994â99):
VBAC Cytotec inductions
13,125
VBAC Cytotec inductions with uterine rupture
525
VBAC Cytotec inductions resulting in death of baby
130
In sum:
More than a half-million women had Cytotec induction.
More than 10,000 women had VBAC Cytotec induction.
More than 500 women with VBAC Cytotec induction had uterine rupture.
More than 100 women with VBAC Cytotec induction and uterine rupture had dead babies.
An unknown but significant number of Cytotec inductions resulted in hyper stimulation of the uterus or rupture leading to brain damage in the baby (anecdotal evidence).
An unknown but significant numberâmore than twentyâof Cytotec inductions resulted in the womanâs death (anecdotal evidence from FDA and Searle).
* The ACOG recommendation against using Cytotec for labor induction in VBAC was issued in November 1999.
SOURCES: Sources of data appear in parentheses. Estimates are all conservative and are based on data from the CDC, ACOG, and two papers: M. Plaut, M. Schwartz, and S. Lubarsky, âUterine Rupture Associated with the Use of Misoprostol in the Gravid Patient with a Previous Cesarean Section,â
American Journal of Obstetrics and Gynecology
180, no. 6 (1999): 1535â40; and H. Blanchette, S. Nayak, and S. Erasmus, âComparison of the Safety and Efficacy of Intravaginal Misoprostol with Those of Dinoprostone for Cervical Ripening and Induction of Labor in a Community Hospital,â
American Journal of Obstetrics and Gynecology
180, no. 6 (1999): 1543â50.
Then, in June 1999, two more papers appeared in the same issue of the
American
Diane Phillips
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