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April 1st, 2016

FINE PRINT

THE STORY

The FDA approved major labeling updates to Mifeprex (mifepristone), the first part of the two pill therapy used in medical abortions.

THE BACKGROUND

Mifepristone blocks progesterone receptors in the uterus and ultimately leads to placental detachment. Misoprostol is a prostaglandin that prompts uterine contractions and leads to expulsion of uterine tissue. The two drugs work together to prompt early pregnancy termination. The FDA approved the drugs for medical abortions in 2000 based on clinical evidence that showed an overall efficacy rate of 96%. More recent evidence shows mifepristone remains equally effective but has fewer side effects at a lower dose, prompting the manufacturer to file a supplemental application with the FDA for new labeling. 

THE OLD PROCESS

Patients would make three doctors visits over the span of two weeks. Day 1 called for 600 mg of oral mifepristone, followed by 400 mcg of misopristol on day 3. Patients would return on Day 14 to confirm pregnancy termination by ultrasound. 

THE CHANGES

The required dose of mifepristone was reduced from 600 mg to 200 mg and the eligibility period was expanded from 7 weeks to 10 weeks (49 days to 70 days). The change requires women to take an additional 400 mcg (for a total of 800 mcg) of misoprostol on day 2-3, but the agency says this can be taken at home. Patients return for reassessment between days 7-14. 
FDA

THE TAKEAWAY

Many docs have followed the updated dosing guidelines for years in an off-label setting, but multiple states (TX, AZ, AR, OH, and OK) have laws that require abortion doctors to follow FDA labeling. Abortion advocates say the new labeling should make medical abortions more accessible to women in the above states and those in rural areas.

SAY IT ON ROUNDS

WHEN YOU SHOW UP DRESSED APPROPRIATELY BUT TWO HOURS LATE

Better watch your timing. The timing hypothesis claims that controversies around post-menopausal estrogen supplementation and its role on cardiovascular health are related to the timing of estrogen initiation following menopause. An RCT showed that women started on estrogen supplementation therapy within 6 years of menopause had a decreased rate of change in carotid artery intima-media thickness (CIMT), a measurement for progression of atherosclerosis, while women started on estrogen therapy 10 or more years after menopause did not. Advocates say less atherosclerosis means less risk of heart disease, while critics point out that CIMT is merely a surrogate marker for atherosclerosis and may not be related to outcomes.
NEJM

WHEN YOU'RE GOING OFF SERVICE AND READY TO SIGN OUT A DISASTER LIST

It never hurts to unload, especially under high pressure. A Phase I study says the same may be true for heart failure with preserved ejection fraction (HFpEF), where few drug therapies have proven effective. A transcatheter interatrial shunt device, designed to shunt blood from the overloaded left heart to the right heart, was tolerated safely at 6 months in roughly 70 patients. The device reduced wedge pressure and symptoms of exercise intolerance in most patients. Phase II trials are up next.
Lancet

WHEN YOU NEED EXTENDED RELEASE COFFEE

Can't help. But injectable extended release naltrexone (Vivitrol) lowered rates of opioid relapse by 21% in criminal justice offenders with a history of opioid dependence. Compared to usual treatment the naltrexone group also had a longer time to relapse (10.5 vs. 5 weeks), though the differences in opioid use did not persist after discontinuation of the drug.  
NEJM

WHEN YOU PREFER YOUR ADVIL BY MOUTH

A prospective study of over 400 patients undergoing ERCP showed that rectal indomethacin did not prevent post-ERCP pancreatitis when compared to placebo. The study contradicts guidelines from the European Society for Gastrointestinal Endoscopy that recommend routine pre-ERCP rectal NSAID administration in all patients without contraindications.
Gastroenterology

BRUSH UP

BRAZIL'S LEAST FAVORITE VIRUS

It's been about 1 year since Zika arrived in South America, and research surrounding the virus has come a long way. Zika is currently associated with Guillan-Barre in adults and microcephaly in infants. You already know that Zika can be transmitted through mosquitos and through sex, but beware the occasional monkey bite. Researchers think the virus, like other flaviviruses, can spread through blood transfusions.

WHAT'S THE EVIDENCE

For the link between microcephaly and Zika? Previously associational, evidence continues to get stronger. Viral RNA has been found in amniotic fluid and brain tissue of fetuses with microcephaly, and a latency period between fetal infection and detection of microcephaly on ultrasound has been described in case studies. Though current recommendations call for serologic testing within 1 week of symptom onset in at-risk pregnant women, longer follow-up may be needed to evaluate for microcephaly in exposed fetuses.

WHAT YOUR HOSPITAL ADMINISTRATION FRIENDS ARE TALKING ABOUT

Resident Appreciation Day, or RAD for short: a new initiative from a group calling themselves the Coalition of Progressive Residency Program Directors (CPRPD). They've advocated for a monthly paid day off for residents in appreciation of their sacrifices and ongoing commitment to patient care. Other issues on the group's docket include ensuring hot daily breakfast and a daily bedsheet change in all call rooms.

Spread the word

  

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