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FDA Approves Abortion Pill

On September 28, 2000 the FDA approved mifepristone (brand name Mifeprex) for use in the United States to end early pregnancy (49 days or less).

Mifepristone is a drug that blocks progesterone, a hormone needed for continuation of pregnancy, when used with a second drug called misoprostol (currently available in the US for treatment of ulcers). It ends pregnancy without surgical intervention in 92 to 95.5% of cases. Mifepristone is currently being used in the UK, Sweden and other European countries.

Distribution is currently limited to doctors who meet qualifications set forth by Danco Laboratories LLC, which manufactures the drug in the US. Physicians must sign a “Prescriber’s Agreement” before any shipment is made.

These qualifications include, but are not limited to:
Ability to accurately date the pregnancy.
Ability to diagnose tubal (ectopic) pregnancies.
Ability to provide surgical intervention in cases of failed or incomplete abortion or have made plans for patient to receive such interventions from another health care provider.
Have read and understand the prescribing information.

Also, under these guidelines physicians must provide patients with a medication guide, fully explain the procedure, and have patient sign a patient agreement. Doctors must notify Danco Labs in the event that a pregnancy is not terminated by use of these generic drugs, or when serious adverse effects are found.

Side effects of these drugs include:
Vaginal bleeding
Diarrhea
Nausea
Vomiting
Headache
Dizziness
Back pain
Fatigue

Mifeprex should not be taken by women who:
Are more than seven weeks pregnant (49 days from onset of last menstrual period)
Have been diagnosed with a tubal pregnancy
Are currently wearing an IUD (intra-uterine device)
Have been treated for a prolonged time with certain steroids
Have bleeding problems or are taking anti-coagulants (blood thinners)
Are allergic to mifepristone or misoprostol

Women who choose to use Mifeprex to end their pregnancy are required to sign and date a “Patient Agreement” provided to the doctor by Danco Labs. By signing this the patient states she has agreed to take the drugs, that her health care provider has explained the procedure in full: including the risks and side effects. She agrees to return to the provider’s office two days after taking Mifeprex for a pregnancy test, and again 14 days after taking Mifeprex.

Medical abortion using this means is conducted over a period of three doctor visits. On the first day the patient will read the medication guide, discuss the benefits and risks of Mifeprex and sign the patient agreement. After a physical exam the patient will swallow three tablets of Mifeprex. On day three the health care provider will test to see if the patient is still pregnant. If this is the case, two misoprostol tablets will be administered. The misoprostol may cause cramping, nausea, diarrhea and other symptoms. On day fourteen, the health care provider will again test for pregnancy. Clinical trials show that five to eight pregnancies out of every hundred are not ended by this procedure.

If the pregnancy has not completely ended there is a chance of birth defects. The health care provider will counsel the patient regarding other choices at this stage, including a surgical procedure to end the pregnancy.

The FDA’s approval of Mifeprex for use in the US is an attempt to provide safe, legal abortions to those women who choose to have them.

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