Essential Drugs in Brief No. 003 - 2001
(2001; 4 pages)
Table des matières
Afficher le documentEditorial
Fermer ce répertoireRegulatory matters
Afficher le documentAntibacterial drugs (1) labelling requirements: information on drug-resistant bacteria
Afficher le documentAntibacterial drugs (2) enrofloxacin - approval for use in poultry withdrawn
Afficher le documentAlosetron - withdrawn: severe adverse reactions
Afficher le documentBasiliximab - severe acute hypersensitivity reactions
Afficher le documentBotulism toxin containing human albumin - marketing authorization suspended
Afficher le documentBudipine - revised data sheet: cardiac adverse reactions
Afficher le documentCapecitabine - revised data sheet: use in patients with renal impairment
Afficher le documentCiclosporin - voluntary recall: generic version not bioequivalent
Afficher le documentCisapride † - revised indications
Afficher le documentGermanium - warning: potentially severe and life threatening reactions
Afficher le documentIntravenous RhO immune globulin † - suspected haemolytic/renal adverse reactions
Afficher le documentMisoprostol - warning against use in pregnant women
Afficher le documentPhenylpropanolamine (PPA) - Overview of national actions
Afficher le documentPioglitazone - revised labelling: cardiac failure
Afficher le documentThioridazine † - QT prolongation, ventricular tachycardia
Afficher le documentTolcapone - Information regarding discontinuation of use
Afficher le documentTrastuzumab - revised data sheet: serious adverse events
Ouvrir ce répertoire et afficher son contenuSafety of medicines
Ouvrir ce répertoire et afficher son contenuFeature: Traditional medicines
 

Misoprostol - warning against use in pregnant women

United States of America. The manufacturer, Searle, has issued a letter to health care professionals to remind them that misoprostol (Cytotec®) administration by any route is contraindicated in women who are pregnant because it can cause abortion. Misoprostol is not approved for the induction of labour or abortion.

Misoprostol is indicated for the prevention of NSAID-induced gastric ulcers (ulcers induced by nonsteroidal anti-inflammatory drugs, including aspirin) in patients at high risk of complications from gastric ulcer, e.g. the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer.

The uterotonic effect of misoprostol is an inherent property of prostaglandin E1(PGE1), of which misoprostol is a stable, orally active, synthetic analogue. The manufacturer has become aware of some instances where misoprostol, outside of its approved indication, was used as a cervical ripening agent prior to termination of pregnancy or for induction of labour, in spite of the specific contraindications to its use during pregnancy.

Serious adverse events reported following off-label use of misoprostol in pregnant women include maternal or fetal death; uterine hyper-stimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.

The manufacturer has not conducted research concerning the use of misoprostol for cervical ripening prior to termination of pregnancy or for induction of labour, nor does Searle intend to study or support these uses, and is therefore unable to provide complete risk information for misoprostol when it is used for such purposes. In addition to the known and unknown acute risks to the mother and fetus, the effect of misoprostol on the later growth, development and functional maturation of the child when misoprostol is used for induction of labour or cervical ripening has not been established.

Health care professionals, are urged to ensure that misoprostol is used only for its approved indication.

Reference: Letter to Health Care Providers, Searle, 23 August 2000.

[http://www.fda.gov/medwatch/safety/2000/cytote.htm]

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