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Timeo is a heavily disabled boy who was born lifeless in 2010 after his mother's uterus ruptured, due to misoprostol use. Timeo's parents have asked for financial compensation and have just received acknowledgment of Timeo's faulty damage.
The link between misoprostol and uterine rupture is ackowledged, as well as three faulty behaviours: too high dosage (50µg vaginally), not in a controlled experimentation, and without parental informed consent. They also acknowledged the fault of infusing the mother with oxytocin despite of a normal and quick labour.
The hospital will therefore have to compensate Timeo.
The association was received last april 29th by the ANSM (national agency for drug safety) which confirmed that misoprostol should not be used for induction, and that the arguments used by obstetricians were unacceptable. It was also admitted that the accidents due to the use of misoprostol were not always declared by obstetricians.
This failure to declare side-effects prevents the ANSM from doing its risk-evaluating job. We have therefore decided to work on these declarations. We advise the people testifying to our association to either declare the side-effects on the ANSM website or to fill in a simplified document that we transmit to the ANSM. We have also planned an information campaign on the procedure in order to list the accidents which were not declared so far.
The alert of the french national agency for drug safety (ANSM) raised the attention of many newspapers in France. Numerous articles were published in papers and over internet. The Timeo's family was interviewed twice by a TV team and a TV broadcast about cytotec is forecast for october.
Recently, in May 2013, The French Minister of Health answered the association by a letter to Timeo et les Autres, declaring that misoprostol should not be used to induce labour and pointed out that ANSM (national agency for drug safety) had taken action in order to set limits to the off-label use of cytotec...
Early 2013, the association Timeo et les autres has launched a petition to demand for an official ban of misoprostol in birth induction, as well as a wide investigation into French maternity wards. So far, it was signed by more than 600 persons.
A google map of the worldwide use of cytotec is now online. Don't hesitate to provide us new testimonies of induction by cytotec.
We also translated our interactive presentation about the induction of labour with cytotec:
Inducing Labour with Cytotec*. But at what cost?
Before accepting an induction of labour for your childbirth, you may demand a full information about:
« This medication can cause strong uterine contractions with risk of miscarriage »
What is Cytotec?
What relationship with childbirth?
Synthetic oxytocin
(Pitocin)
E2 prostaglandins
(dinoprostone)
What are the other drugs to induce Labour?
Molecule: Misoprostol
Antiulcer, class E1 synthetic prostaglandin
Indicated for the treatment of gastric ulcer
On the market since 1985
This
side effect
has led some gynecologists to use cytotec
to induce abortions
and then
to induce labor
on living children.
The drug insert says:
«
Administration to women who are pregnant can cause birth defects, abortion, or premature birth. Uterine rupture has been reported [...] beyond the eighth week of pregnancy.
»
Oxytocin infusion
Cervidil
Prostin E2
Propess
Why some obgyn prefer Cytotec to other medications?
Can you legally use an off-label drug*?
Yes, but...
Excessive uterine activity leading to :
Dinoprostone
(Cervical rippening)
(on mature cervix)
Thank you for your attention!
http://timeo-asso.fr
http://bebecyto.org
Find us on:
@bbcyto
Despite the
lack of Marketing Authorization
for obstetrical use
Whereas several official organizations recommend
not to use cytotec outside of clinical trials
In the absence of medical consensus
with scientific evidence-based prescriptions
in the absence of alternative drugs,
with the free and informed consent of the patient,
with high-risk forensics
the reason of the induction,
the methods used,
the benefit/risk ratio.
that has not been tested in the state of the art?
whose danger is highlighted by many studies?
which no one can control the risks?
which has already caused many tragedies?
which is not recommended by health authorities?
just to save some time and money?
What are the risks of Cytotec?
Fetal distress (=emergency)
Post partum haemorrhagia
Uterine rupture
Baby disabilities (because of birth asphyxia)
Amniotic fluid embolisms
Death of the mother or baby
* Cytotec is an anti-ulcer misused to induce labour in childbirth.
The laboratory reports that the drug has not received approval for its use in obstetrics.
93€
62€
$100
2,78€
40€
Prepidil
Very cheap
Easier storage
More efficient (faster delivery)
Reduces the need for oxytocin
0,32€
the pill
hundred times cheaper than PGE2
UK study calculated that inducing systematically with cytotec could save £3.9 millions per year!
Often
Rare
Very rare
The significant disadvantages of Cytotec
Difficult to dose precisely
(25µg = 1/8th of pill!)
Unpredictable uterus reaction
(Russian roulette effect)
Very long half-life of the molecule
(90min by oral route, 253min by vaginal route)
Its safety has not been adequately evaluated
(Off-label* use)
The effect of Cytotec can not be stopped in case of problems
Inducing Labour with a drug...
Uh!
No! Thanks!
[PGE2]
but at what cost?
*off-label=without Markinting Authorization
*off-label=without marketing authorization
Do not forget to sign the petition calling for a ban of cytotec
Petition
Misoprostol definition
May vary from one country to another
To be continued...
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