Misoprostol (marketed as Cytotec in the USA) is a drug for the treatment of gastric ulcers. It’s been commonly used off-label for labour induction, early abortion and miscarriage since the 1990s because it contracts the uterus. Its use for labour induction isn’t approved by the US Food and Drug Administration, other American drug regulatory bodies, the pharmaceutical company that manufactures the drug (Searle), nor obstetric organisations including the British Royal College of Obstetricians and Gynaecologists, and the International Federation of Gynecology and Obstetrics.
There is a huge loophole in the drug regulatory system which allows any drug which has been approved for one use to be used for any other use, in any dose. This off-label use is common among the medical profession. And it’s completely legal. However, using one drug off-label will have a different level of risk than using another off-label. When it comes to the off-label use of misoprostol for induction, there is no agreement about the ‘right’ dosage, the interval between dosages or how it’s administered (vaginally or orally).
Misoprostol’s appeal is that it’s incredibly cheap, much cheaper than other drugs used for inductions. It also works much faster and, with my cynical hat on, this enables hospitals to get pregnant women in and out of their doors quicker. However, the faster and stronger contractions misoprostol produces can lead to hyperstimulation of the uterus which can not only affect the mother, but also the baby. If the uterus is overstimulated, the placenta can be sheared off or the uterus can rupture. For the baby, the time between contractions during normal labour gives him or her a chance to recover and prepare for the next contraction. Logically, if the window for the baby to recover is dramatically reduced, he or she can become distressed more easily and also can be deprived of oxygen, like in the cases I mentioned in this previous post, and, of course, in Sofia’s case. Also, unlike other commonly used induction drugs, it cannot be immediately and effectively stopped if adverse reactions occur in the mother and/or the baby.
The studies that have been done into the use of misoprostol for induction have been too small to produce any adequate evidence. This is an excellent overview (published in 2005) of the medical literature about misoprostol for induction.
The Cochrane Collaboration is an independent, not-for-profit “international network of people helping healthcare providers, policy makers, patients, their advocates and carers, make well-informed decisions about human health care”. In 1999 the Cochrane Database of Systematic Reviews, published the following statement concerning the use of misoprostol for induction: “The increase in uterine hyper-stimulation with fetal heart rate changes is a matter for concern. The studies were not sufficiently large to exclude the possibility of uncommon serious adverse effects. The increase in meconium stained liquor also requires further investigation. Misoprostol (Cytotec) cannot be recommended for routine use for labour induction at this stage. It is also not registered for such use in the US.”
Searle, the drug company that makes misoprostol distributed a letter (although only in in the US, not the UK) in August 2000 warning against its use in pregnant women. Most probably this was spurred on by a large lawsuit brought by the husband of an Oregon woman who died after a misoprostol induction. The letter explicitly stated “Cytotec may cause the uterus to rupture (tear) during pregnancy if it is used to bring on (induce) labor.” This “may result in severe bleeding, hospitalization, surgery, infertility or death.” References were made to reports of uturine rupture and death associated with the use of the drug for inductions.
In June 2001 the NHS National Institute for Clinical Excellence (NICE) issued their Clinical Guideline on Induction of Labour. It states “misoprostol is a drug that has been investigated for the induction of labour. It is not licensed in the UK for obstetric use and the safety aspects have not been fully evaluated. The full guideline has a section on this product and recommends that its use must be restricted to clinical trials. The NICE Guideline recommends that the risks and benefits of vaginal/oral misoprostol for the induction of labour should be evaluated using commercially produced tablets of appropriate dose and randomised controlled trials. ”
Misoprostol is given to women often without their knowing it is unlicensed and made by a drug company who takes no responsibility for its use in this way. This gives the woman no opportunity for informed consent. In any other situation would patients be used as guinea pigs without their consent?