Medical Abortion

MEDICAL ABORTION

What is Medical (drug-induced) Abortion?

Medical abortion is a term used in medical literature to describe a procedure or regimen that uses various pills to end an established pregnancy. ^{(1) (2)}

Medical abortion is a drug induced alternative to surgical and vacuum aspiration abortion for women who elect to terminate an early pregnancy. ⁽³⁾

MIFEPRISTONE

Medical abortion terminates an early pregnancy through the use of two drugs; Mifepristone and Misoprostol. (4)

MISOPROSTOL

Mifepristone, often called “The Abortion Pill”, or RU-486, is an anti-progestin that blocks the action of progesterone which is necessary to establish and maintain placental and embryo attachment. ^{(5) (6)}

Mifepristone is used in conjunction with misoprostol, a prostaglandin analogue, available in the United States under the brand name Cytotec®. Misoprostol, when administered orally or vaginally, stimulates uterine contractions that expel the embryo and placental tissue. ⁽⁵⁾

Though reference to mifepristone as the “abortion pill” makes early medical abortion sound like a simple procedure, it actually involves the administration of two drugs on separate days, a span of several days before the abortion occurs and up to 2–3 weeks of bleeding and spotting. ⁽⁷⁾

Medical abortion using mifepristone plus the prostaglandin misoprostol is the most effective method of abortion at gestations of less than 7 weeks. ⁽⁸⁾

MEDICAL ABORTION Q & A

What is the FDA approved regimen for medical abortion?

In 2000, the U.S. FDA approved Mifeprex (mifepristone) for the termination of early intrauterine pregnancy, defined as 49 days or less counting from the last menstrual period. ⁽⁴⁾  (See U.S. FDA Approved Medical Abortion Regimen – Dosage and Administration)

The FDA-approved regimen for medical abortion consists of taking: ⁽⁹⁾

• 600 milligrams (mg) (three 200 mg tablets) of mifepristone orally on Day 1 in the provider’s office
• 400 micrograms (mcg) (two 200 mcg tablets) of misoprostol orally on Day 3, also in the provider’s office.
• A post-treatment examination is to be completed on approximately Day 14.

Why are physicians using alternative/unapproved medical abortion regimens?

FDA is aware that many medical practitioners use of off-label or modified (alternative/unapproved) regimens, which may include prescribing different doses of mifepristone and misoprostol, dosing misoprostol on a different day, and/or advising patients that the misoprostol tablets be inserted into the vagina. ⁽¹⁰⁾

Although off-label prescribing — the prescription of a medication in a manner different from that approved by the FDA — is legal and common, it is often done in the absence of adequate supporting data. ⁽¹¹⁾

Unapproved drug uses are those that do not appear in a product's U.S. Food and Drug Administration (FDA)-approved labeling and are not approved by the Agency. Such uses commonly are referred to as "off-label," or "unapproved” uses. ⁽¹²⁾

The safety and effectiveness of Mifeprex (mifepristone) off-label dosing regimens, other than the one approved by FDA, including use of oral misoprostol intravaginally, has not been recognized and accepted by the FDA. ⁽¹³⁾

What qualifications must a provider have to administer mifepristone  and misoprostol to a patient for medical abortion?

(See PRESCRIBER'S AGREEMENT)

The gestational age must be determined before a provider can administer mifepristone and misoprostol to a pregnant woman. ⁽⁴⁾

The provider must have the ability to diagnose ectopic pregnancy.

The provider administering mifepristone and misoprostol for medical termination of early pregnancy must be able to provide surgical intervention or have made plans for the provision for such care through other qualified physicians, and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary. ⁽⁴⁾  (See DOSAGE and ADMINISTRATION)

Each patient must be provided a Medication Guide. The provider must fully explain the procedure to the patient, provide the patient with a copy of the MEDICATION GUIDE and PATIENT AGREEMENT, patient must have the opportunity to read and discuss them, and the patient and the provider needs to sign the Patient Agreement document.

What are some differences between medical and surgical abortion?

Medical abortion has been associated with higher rates of prolonged bleeding, nausea, vomiting, and pain than is surgical abortion, and the rate of use of pain drugs is greater with medical abortion. Moreover, medical abortion has a lower rate of success than surgical abortion. ⁽¹⁴⁾

MEDICAL ABORTION HEALTH RISKS

What are possible health risks of medical abortion?

The potential risks of medical abortion include: (2) (See HEALTH RISKS)

• Failure: Incomplete Abortion, Continuing Pregnancy, Birth Defects
• Bleeding & Hemorrhage
• Infection
• Death
• Severe Pain
• Undiagnosed Ectopic Pregnancy
• Nausea, Vomiting, Diarrhea
• Damage to the Uterus ⁽¹⁵⁾
• Induced Abortion & Autoimmune Disease
• Medical abortion & Future Pregnancy
• Mifepristone-Induced TTP

Surgical intervention may be required for failed abortion, excessive bleeding, pregnancy tissue left in the uterus, or other serious medical conditions. ⁽⁹⁾ (See BOXED WARNINGS and WARNINGS)

Infection and death have been reported in previously healthy women. ^{(13) (16) (17)}

Mifepristone may predispose to lethal infection by impairing a patient’s immune response caused toxigenic Clostridium sordelli and other pathogens. ^{(18) (19)}

Medical abortion with mifepristone and misoprostol can involve the risks of serious complications, infection, and death. ⁽⁹⁾

UNDERSTANDING THE ISSUES & RISKS OF MEDICAL ABORTION

What important medical abortion issues should patients consider?

It is important for patients to be fully informed about the issues and risks of medical abortion with mifepristone and misoprostol. Patients need to understand: ^{(4) (5) (13)}

• Risks and benefits of all available options; medical or vacuum abortion options.
• Detailed information about choosing a specific regimen; whether it is an FDA approved regimen or an unapproved alternate regimen commonly used by providers.
• The length of time the patient can expect the entire process to take.
• The amount of bleeding a patient may experience, including the size of clots and the embryonic tissue a patient may see.
• The risks, warning signs, side effects, possible complications or death.
• Pain management, follow-up care, and what to do if the patient has any questions.
• Accessibility to a medical care facility in case of an emergency.
• The need for follow-up visits especially on the 14th day after mifepristone is administered to confirm the pregnancy has been terminated and there are no complications.
• The need for a surgical intervention or vacuum aspiration abortion procedure if medical abortion is incomplete or a failure.