Off-label use of misoprostol linked to abortion deaths


What Is Misoprostol?

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Misoprostol is the generic form of the brand-name drug Cytotec, which is used to prevent ulcers in people who take certain arthritis or pain medicines.

Drugs that can cause stomach damage include aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Anaprox, Naprosen), celecoxib (Celebrex), diclofenac (Voltarin, Cataflam), indomethacin (Indocin), and meloxicam (Mobic).

Misoprostol is a synthetic prostaglandin. It works by protecting the stomach lining and decreasing stomach acid secretion.

The Food and Drug Administration (FDA) approved the medication in 1988. The drug was originally manufactured by G.D. Searle & Company, and generic forms of misoprostol are now made by several drug manufacturers.

Misoprostol and Abortion

Misoprostol is sometimes used off-label to end an early pregnancy. (Off-label use means that the FDA has not approved the drug for this purpose.)

The drug is most effective when it's used in combination with methotrexate or mifepristone. Misoprostol can be given orally, buccally (dissolved between the gums and cheek), or vaginally for this purpose.

The FDA has reported that a few women have died from severe infection after having an abortion using mifepristone and vaginal misoprostol.

You should call your doctor immediately if you experience any signs of infection, which may include weakness, pain, muscle aches, nausea, and diarrhea. This rare infection may not cause a fever.

Misoprostol is also sometimes used off-label to induce labor or decrease blood loss after delivery of a baby. However, the FDA has issued an alert about the potential dangers of using misoprostol for these purposes. The risks include a torn uterus, the need for a hysterectomy, and death of the mother and baby.

Pregnancy and Misoprostol

Misoprostolis a Pregnancy Category X drug, which means it is likely to harm an unborn baby, causing birth defects and premature birth. The drug can also harm the pregnant woman, causing uterine rupture, uterine bleeding, miscarriage, or an incomplete miscarriage. You should use an effective form of birth control while taking misoprostol and for at least one month after you stop using it.

Women shouldn't take their first dose of misoprostol until the second or third day of their menstrual period to ensure that they aren't pregnant.

It's not known whether this drug passes into breast milk or if it could harm a breastfeeding baby. You should talk to your doctor about these risks.

Misoprostol Warnings

Before taking misoprostol, you should tell your doctor if you have:

  • Inflammatory bowel disease (IBD)
  • Irritable bowel syndrome (IBS)
  • Any other intestinal problems
  • Heart disease

You should also alert your physician if you suspect you are dehydrated before taking this medicine.

This drug must be taken regularly for you to benefit. Don't stop taking misoprostol without first talking to your doctor.

Call your doctor if you experience severe nausea, stomach pain, or diarrhea lasting several days while on misoprostol.

Misoprostol Side Effects

Common Side Effects of Misoprostol

You should tell your doctor if any of the following side effects are severe or don't go away:

Serious Side Effects of Misoprostol

You should call your doctor immediately if you experience any of the side effects listed in the Warnings section or any of the following serious side effects:

  • Bloody vomit
  • Bloody or black, tarry stools
  • Any signs of infection

Misoprostol Interactions

You should always tell your doctor about any prescription, non-prescription, illegal, and recreational drugs; herbal remedies; and nutritional and dietary supplements you're taking, especially:

Misoprostol Dosage

Misoprostol comes as a tablet to take by mouth. It's typically taken four times a day, after meals and at bedtime with food.

You should follow the instructions on your prescription label carefully when taking this medicine. Don't take more or less of the drug than your doctor prescribes.

Misoprostol Overdose

Symptoms of a misoprostol overdose include the following:

  • Stomach upset or pain
  • Diarrhea
  • Trouble breathing
  • Irregular heartbeat
  • Low blood pressure
  • Tremor or seizure

If you suspect an overdose, you should contact a poison control center or emergency room immediately. You can get in touch with a poison control center at (800) 222-1222.

Missed Dose of Misoprostol

If you miss a dose of misoprostol, take it as soon as you remember.

However, if it's almost time for your next dose, skip the missed dose and continue on your regular dosing schedule. Don't take extra medicine to make up for a missed dose.

Misoprostol Pictures

Misoprostol 100 mcg-IVA, white, round,
Misoprostol 100 mcg-GRE, white, round,
Misoprostol 200 mcg-GRE, white, hexagonal,
Cytotec 100 mcg, white, round,
Misoprostol 200 mcg-IVA, white, round,
Cytotec 200 mcg, white, hexagonal,

By Lynn Marks | Medically Reviewed by Robert Jasmer, MD

Latest Update: 2015-01-29
Copyright © 2014 Everyday Health Media, LLC

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