Supreme Court decision this summer could gut FDA\'s authority over drugs.

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After years of the worsening burden of unsafe abortion and attendant morbidities and mortalities in Nigeria, a National Guideline on the Safe termination of pregnancy for legal indications was enunciated. This report presents and discusses an illustrative case of a hydranencephaly that benefited from it. A 43-year old multipara was informed during routine ultrasonography at booking for antenatal care, at 16 weeks of gestation, of a major defect in her baby and advised to meet her physician. Following a repeat high- resolution ultrasonography and discussions between the Obstetricians, Neurosurgeon, and Ultrasonologist, the woman was counseled on the diagnosis. At her insistence and provision of written consent, medical abortion with Mifepristone and Misoprostol was successfully instituted.

BACKGROUND: Some women who take mifepristone, a progesterone receptor antagonist, in order to terminate their pregnancies, change their minds and desire to stop the medical abortion process. There are only two articles in the medical literature documenting the reversal of the effects of mifepristone.
OBJECTIVE: We present and analyze a series of women who attempted to reverse the effects of mifepristone by taking supplemental progesterone to determine if the reversal of the effects mifepristone with progesterone is possible and safe. Additionally, we compare different progesterone regimens to determine relative efficacies.
METHODS: This is an observational case series of 754 patients who decided to attempt to reverse the medical abortion process after taking mifepristone but before taking the second drug in the protocol, misoprostol. We followed the patients, who were given progesterone in an effort to reverse the effects of mifepristone, and conducted statistical analyses to determine the efficacies of different protocols compared to a control mifepristone embryo survival rate, derived from the literature.
RESULTS: Intramuscular progesterone and high dose oral progesterone were the most effective with reversal rates of 64% (P < 0.001) and 68% (P < 0.001), respectively. There was no apparent increased risk of birth defects. Conclusions: The reversal of the effects of mifepristone using progesterone is safe and effective.

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A primigravid immigrant woman presented for termination of a 16-week pregnancy. The cervix was obscured by a transverse vaginal septum and was only identifiable by ultrasound. We used mifepristone for cervical preparation before concurrent septoplasty and dilation and evacuation.

OBJECTIVE: Early pregnancy failure (EPF) is a common complication of pregnancy. Surgical intervention carries a risk of complications and, therefore, medical treatment appears to be a safe alternative. Unfortunately, the current medical treatment with misoprostol alone has complete evacuation rates between 53% and 87%. Some reports suggest that sequential treatment with mifepristone and misoprostol leads to higher success rates than misoprostol alone.
METHODS: To evaluate the added value of mifepristone to current non-surgical treatment regimens in women with EPF we performed a systematic literature search. Electronic databases were searched: PubMed, Cochrane Library, Current Controlled Trials, and ClinicalTrials.gov. Clinical studies, both randomised and non-randomised trials, reporting on the added value of mifepristone to current non-surgical treatment regimens in women with EPF were included. Data of sixteen studies were extracted using a data extraction sheet (based on the Cochrane Consumers and Communication Review Group\'s data extraction template). The methodological quality was assessed using the Cochrane Collaboration Risk of Bias tool.
RESULTS: In five randomised and eleven non-randomised trials, success rates of sequential treatment with mifepristone and misoprostol in case of EPF varied between 52% and 95%. Large heterogeneity existed in treatment regimens and comparators between studies.
CONCLUSIONS: The existing evidence is insufficient to draw firm conclusions about the added value of mifepristone to misoprostol alone. A sufficiently powered randomised, double blinded placebo-controlled trial is urgently required to test whether, in EPF, the sequential combination of mifepristone with misoprostol is superior to misoprostol only.

OBJECTIVE: To report two cases of women who presented with amenorrhea, lower abdominal pain, and vaginal bleeding and who were diagnosed with advanced interstitial pregnancy after initial negative laparoscopies.
METHODS: Case report.
METHODS: Early pregnancy unit of district general hospital.
METHODS: A 39-year-old woman with a history of right salpingectomy for ectopic pregnancy and a 28-year-old woman with a history of miscarriage.
METHODS: Laparoscopic salpingocentesis with methotrexate (50 mg/m(2)) after aspiration of an equivalent amount of amniotic fluid. The remainder, based on the calculated dose, was given intramuscularly. Oral mifepristone (200 mg) was given postoperatively.
METHODS: Complete resolution of interstitial pregnancy in both instances with two subsequent, successful intrauterine pregnancies delivered at term in the second patient. There were no intraoperative or postoperative complications.
RESULTS: Expected decline in beta human chorionic gonadotropin (beta-hCG) levels without the need for any further intervention(s).
CONCLUSIONS: Interstitial pregnancy may be successfully and safely managed by the use of laparoscopic salpingocentesis with methotrexate and mifepristone despite high initial beta-hCG levels.

In Italy mifepristone is not yet marketed. Gynaecologists in our hospital asked to use this medication as a less traumatic method for voluntary abortions. We followed the standard procedure defined by the Italian Health Ministry (IMH) for purchasing drugs from abroad but encountered several unexpected barriers. Starting from this case, this paper is aimed at identifying these barriers which we found to be not only professional, but also ethical, religious and moral.