Log in

Cytotec, a drug diverted from its use, withdrawn from the market in 2018

Cytotec, a drug against stomach ulcer, diverted to trigger eventual deliveries at the risk of maternal and child health, will be withdrawn from the French market as of March 2018, Drug Agency.

"The laboratory Pfizer France has informed us of its decision to withdraw from the French market its product Cytotec, widely used in non-AMM gynecology (out of the indications for which it is planned) that will be effective 1er March 2018, 'AFP Dr Christelle Ratignier-Carbonneil, Deputy Director-General of the ANSM Medicines Agency on the occasion of the 6e Etats généraux organized on Thursday in Paris by the association the Patient Defense Link.

"The Cytotec, on the market since 1987 is very little used in gastroenterology and is mostly in gynecology", mainly for abortion and the artificial trigger of delivery delivery, according to ANSM.

The deadline, she said, will allow manufacturers who are already marketing the drugs Gymiso and Misoone, containing the same molecule, to increase their production in order to "secure access to drug abortion" whose number is 128.000 declared in 2015.

Cytotec, which is normally taken orally, contains misoprostol, a molecule that belongs to the prostaglandin family. "Misoprostol is a great product that makes real services," says Dr. Thierry Harvey, a gynecologist and obstetrician, who discusses its use for spontaneous miscarriages.

But it is the use of Cytotec vaginally to trigger the eventual delivery of a viable child and the serious risks that this entails for the health of the mother and the child which is a "scandal" the association Timéo who militated for its ban with the support of the Link.

This diverted use indeed involves risks of overdosing because it supposes to use one eighth of the tablet which is dosed at 200 micrograms, which given its size (less than one centimeter) is at least hazardous, notes Dr. Harvey " reassembled as a cuckoo "against this dangerous practice, motivated by financial considerations.

- 'Good news' -

The risk is to cause contractions too strong, and poor oxygenation of the fetus, according to the obstetrician.

A withdrawal qualified as "good news" by Alain-Michel Ceretti, founder of the Link. "But the Cytotec affair reveals the weakness of state authority in matters of health security, a problem at the center of the States-General," he said.

The agency of the drug had already warned, in 2013, against the serious risks for the mother and the child (uterine rupture, haemorrhage ...) of this use.
"The law must be amended to prohibit practices identified as dangerous," adds Ceretti.

"My son stayed between life and death several days, I had the uterus completely torn, I could not have any more children. It is not possible to live this for women budget, "says Aurélie Joux, founder of the association Timéo, the name of her child" born under cytotec ", overdosed, in November 2010.

She has since won a trial late 2016 before the tribunal of Versailles, in 1e instance, against the hospital of Poissy for the damage suffered by his son heavily handicapped with "enforceable sanction"at once. Sham insurer of the establishment has appealed, specifies its lawyer Serge Beynet.

"In order to save money, hospitals prefer to use Cytotec, which costs practically nothing, it is just scandalous," said the mother, who, in addition to the suffering she had suffered, was not informed of the products administered to induce childbirth, while the term was exceeded by 3 days.

Drugs based on prostaglandins intended for the artificial triggering of labor, in gel or in buffer, cost much more expensive than the Cytotec (30 centimes the tablet).

"We need a generic, we need misoprostol, cheap as for Cytotec but at different dosages (25, 50, 200 ...)," says Dr. Harvey.

An application for authorization to place the Azanta Danish laboratory on the dosage of 25 micrograms is being evaluated and may be available in 2018, says Ratignier-Carbonneil.

a3p-100pxhaut logo


Commit to share
Transmit and progress together
Promoting innovation

The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

More info on video (Versiongb - drapeauitalie )

  group    administrators A3P
& Project Managers

letter   newsletter A3P