Searle Cytotec Warning Letter

Weitz and Luxenberg is no longer accepting Cytotec cases.

On August 23, 2000, the pharmeceutical company Searle issued a warning against using Cytotec for the unintended purpose of inducing labor. It is your doctor's job to know that Cytotec is not safe for labor induction and it can be medical malpractice if used for that purpose. If you or a loved one has been injured by the misuse of Cytotec, get your free legal review before time runs out.

August 23, 2000

Cytotec® (misoprostol)

IMPORTANT DRUG WARNING CONCERNING UNAPPROVED USE OF INTRAVAGINAL OR ORAL MISOPROSTOL IN PREGNANT WOMEN FOR INDUCTION OF LABOR OR ABORTION

Dear Health Care Provider:

The purpose of this letter is to remind you that Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion. Cytotec is not approved for the induction of labor or abortion.

Cytotec is indicated for the prevention of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)-induced gastric ulcers 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 Cytotec is an inherent property of prostaglandin E₁(PGE₁), of which Cytotec is stable, orally active, synthetic analog. Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to termination of pregnancy, or for induction of labor, in spite of the specific contraindications to its use during pregnancy.

Serious adverse events reported following off-label use of Cytotec in pregnant women include maternal or fetal death; uterine hyperstimulation, 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.

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

Searle promotes the use of Cytotec only for its approved indication. Please read the enclosed updated complete Prescribing Information for Cytotec.

Further information may be obtained by calling 1-800-323-4204.

Michael Cullen, MD
Medical Director, U.S.
Searle

ACT NOW! It is essential that you inquire about your case as soon as possible. Litigation may be the only way to receive the damages to which you may be entitled, such as medical and health care bills, lost or diminished wages, and financial compensation to heirs in the case of death. Your individual state's law may limit your time to bring a legal claim to protect your rights. You need to have your Cytotec claim evaluated immediately!

see also:

Breaking News Cytotec Misoprostol Resources: Cytotec Breaking News
Cytotec Misoprostol Information: Cytotec (Misoprostol) Breaking News

Major Label Changes FREE information about Cytotec Misoprostol - Major Label Changes from FDA
Cytotec Major Label Changes: from the FDA

News & Warnings Cytotec Lawsuits FREE Research Resources
ree information on Cytotec and Cytotec lawsuits.