Re: Use of Cytotec

• Messages sorted by: [ date ][ thread ][ subject ][ author ]
• Next message: Lysandra: "Re: No luck with Prostin Gels, now trying Cytotec..."
• Previous message: BettyBoop: "possible pregnancy"

"Searle regards the administration of misoprostol, either alone or in combination with other drugs to interfere with the course of pregnancy, as misuse of the product. ... We strongly condemn misuse of the product."68

Note: Cytotec is an anti-ulcer drug, intended for patients at risk of developing stomach ulcers from high doses of aspirin-like medications taken for conditions such as arthritis.

On August 23, 2000 Searle issued a letter to all Health Care Practitioners entitled "Important Drug Warning Concerning Unapproved Use of Intravaginal or Oral Misoprostol in Pregnant Women for ... Abortion." It states in part:

Serious adverse events reported following off-label use of Cytotec in pregnant women include maternal and fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy [removal of uterus] or salpingo-oophorectomy [removal of ovaries and Fallopian tubes]; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.69

The "black box" warnings on Cytotec's label state in part: UTERINE PERFORATION HAS BEEN REPORTED FOLLOWING ADMINISTRATION OF COMBINED VAGINAL-AND-ORAL CYTOTEC IN PREGNANT WOMEN TO INDUCE ABORTION. IN EACH OF THESE REPORTED CASES, THE GESTATIONAL AGE OF THE PREGNANCIES WAS UNKNOWN.

--------------------------------------------------------------------------------

68 Letter to the Editor, signed W. Wilson Downie, International Medical -------------------------------------------------------------------------------- Operations, G.D. Searle, The Lancet, vol. 338:247 (July 27, 1991).

--
--------------------------------------------------------------------------------

69 Letter from Michael Cullen, MD, Searle's U.S.  Medical Director,
dated August 23, 2000, available at
http://www.fda.gov/medwatch/safety/2000/cytote.htm.

• Next message: Lysandra: "Re: No luck with Prostin Gels, now trying Cytotec..."
• Previous message: BettyBoop: "possible pregnancy"