The FDA released a new approved utilization regime for Mifepristone, a medication used to induce first trimester abortions:
Mifeprex is approved, in a regimen with misoprostol, to end a pregnancy through 70 days gestation (70 days or less since the first day of a woman’s last menstrual period). The approved Mifeprex dosing regimen is:
On Day One: 200 mg of Mifeprex taken by mouth
24 to 48 hours after taking Mifeprex: 800 mcg of misoprostol taken buccally (in the cheek pouch), at a location appropriate for the patient
About seven to fourteen days after taking Mifeprex: follow-up with the healthcare provider
From Medscape, a description of the previous FDA regime:
Numerous protocols have been studied and are in use, but only 1 has been approved by the FDA.( Table 3 and Table 4 ). The FDA-approved regimen can be initiated up to 49 days after the first day of the LMP and consists of mifepristone 600 mg orally on day 1, misoprostol 400 mcg orally provided at the doctor’s office on day 3, and a follow-up appointment on days 12-20. This protocol is 92% effective in inducing a complete abortion.[12,13] It is hoped that studies using different variations of the FDA-approved regimen will lead to expanded options that are safe and reduced costs.
There are a couple of major changes here. The first is the dose for Mifeprex went down and the second round medication dosagage went up. That may or may not be clinically important. From a policy perspective there are three major changes.
The first is that the FDA allowed window to have a medical abortion goes from 7 weeks after the last day of the woman’s menstrual cycle to 10 weeks. This gives women a lot more flexibility and decision time from the point where she knows she is pregnant to the point where the least invasive option can is no longer FDA approved.
Secondly, the window for the follow-up dosage expands; again this is flexibility which means compliance and follow-up is easier.
More importantly, the change in location for where that second dose is administered is critical. Previously, that second dose was to be down at the doctor’s office. Now it is as a location appropriate for the patient. That is massively more flexible as it means an individual could take the second pill home with her.
Why is this important? It is a counter-move to the proliferation of TRAP anti-abortion access laws as Think Progress explains:
anti-abortion lawmakers — who have mounted an incremental strategy based on chipping away at abortion from all angles — were quick to exploit the discrepancybetween the official FDA label and the real-world medical practice. States started passing laws requiring doctors to stick to the outdated FDA method of prescribing the abortion pill. It was easy for politicians to misleadingly argue that they were simply interested in keeping women safe and ensuring that abortion patients aren’t taking dangerous, unregulated drugs.
This reduces practical restrictions on pharmaceutical abortion access by reducing the number of trips needed while also expanding the time option space. As a side note, it allows clinics a little more flexibility to cope with other TRAP laws as some of the current surgical abortions in restrictionist states can be transferred to pharmaceutical abortions which will free up staff and appointment slots to handle more misogynistic bullshit.
So staffing the federal bureaucracy matters.
Let’s keep that in mind for November!
“Previously, that second dose was to be down at the doctor’s office. Now it is as a location appropriate for the patient.”
“800 mcg of misoprostol taken buccally (in the cheek pouch), at a location appropriate for the patient”
I’m such a dope: I thought that meant “in a part of the cheek appropriate for the patient.” Duh.
How lovely, in wake of yesterday’s USSC decisions. And no Scalia to interfere in any legal challenge. Even the employees of the Little Sisters of the Poor will ultimately have access. If you were trying to unsettle wing nuts, you couldn’t do better.
And it’s just Wednesday.
This may be even more important if the Zika virus spreads to the mainland US. It’s already in Puerto Rico. Now if only the Latin American countries which have been severely affected by Zika would shake off the Church’s heavy hand.
Another reason it matters who you elect President. This is some good news for women’s health.
@Origuy: Zika Q for you: once infected, always infected? Like HIV? Or more like the flu (temporary)? So if a 10 y.o. female gets it this summer via mosquito, is she in the clear to have kids 15 years later, or always at risk for defects the rest of her life?
@Face: I’m not a doctor, but I think the virus only lasts a short time in the body. The NYT has a FAQ:
Rich, I’ve heard that birth control options are important for college soccer referees….
I’m sure that Susan Sarandon will explain to us how Donald Trump’s FDA will be just like Hillary Clinton’s.
Zika is not a retrovirus (i.e. like HIV), so immunity does develop. Being infected for the first time while pregnant is the biggest risk.
Medical abortion has been practiced for a lot of years, but in the context of an ongoing patient-physician relationship. Surgical abortion happens when someone doesn’t necessarily have a regular doctor – which generally means they are poor. Kudos to the FDA towards helping balance the burden on women of different socio-economic class.
So perhaps I am being a bit dim, since my experience with abortion has always been with the surgical variety, which naturally involved family planning clinics – a woman can get this prescription from her regular MD? She doesn’t have to go to a FPC?
Ella in New Mexico
There was a time when you could actually get a doctor to diagnose you online for a variety of maladies, and then they would prescribe medications which you could order from an affiliated pharmacy and have shipped to you.
Are there any current legal issues to prevent women from being able to purchase these medications online if their state prevents them from local access?
Because if not, this is actually pretty big news for millions of women.
@Origuy: That is correct, the only danger (as far as anyone knows) is if a woman gets infected while pregnant.
It only lasts a short time in the body, but there are about 3.9 million babies born in the US every year. Even if only 5 percent of those pregnant women got infected with Zika, that’s 195,000 severely disabled infants that would be born every year.
Here in California, she doesn’t even need an MD; other medical personnel who can prescribe medicine, like nurse practitioners, can also give her one.
@Ella in New Mexico:
Well, women can get the “morning after pill” online, so I would imagine that they could get this one online as well, but IANAD…or a nurse.
But it would definitely be a Biden-style BFD for women if so.
From the CDC:
Anyone who lives in or travels to an area where Zika virus is found and has not already been infected with Zika virus can get it from mosquito bites.
Once a person has been infected, he or she is likely to be protected from future infections.
Zika virus can be spread by a man to his sex partners.
In known cases of sexual transmission, the men developed Zika virus symptoms. From these cases, we know the virus can be spread when the man has symptoms, before symptoms start and after symptoms resolve.
In one case, the virus was spread a few days before symptoms developed.
The virus is present in semen longer than in blood.
If we had a decent public health system, Zika would be very sad for a few families, but not a crisis. Since we have a virtually non-existent public health system, it’s going to be a goddamn fiasco, particularly in those Southern states that are anti-abortion/anti-birth control and have a lot of mosquitoes.
Scientists are still sorting out the links between Zika and microcephaly. There was a big study published out of Reunion, in the Indian Ocean, on an outbreak several years ago that yielded useful data. Have to be careful about applying it wholesale to Brazil, or any place else Zika appears, though, because viral strains can vary, as do their human hosts. But it at least makes biological sense that first trimester exposure appears to be riskiest.
They can get the morning after pill online because it’s now an OTC medicine, which medically induced abortion isn’t and isn’t likely to be. The key thing for becoming available OTC is safety when taken without medical supervision. The morning after pill can be taken safely without talking to a doctor before or after, so it’s a logical candidate for being available OTC; it was only political opposition that kept it prescription only for as long as it was. But medically induced abortion still requires a followup visit with a physician. As long as that’s true, it’s likely to remain prescription-only, because there’s too much risk of women without good access to a doctor taking it and having the complications that are supposed to be dealt with during the followup visit.
Ella in New Mexico
Mark my words:
Thanks to our now omnipresent friend, Global Warming, the Zika virus will become a pretty significant infectious disease over the next few years in the US, particularly in those backward southern states that have attempted to outlaw abortion or access to birth control.
The very same activists and legislators who crafted and the governors who signed these draconian laws are either in their childbearing years, have a spouse who is or have daughters who are starting their families.
The idea of widespread cases of microcephaly and other profound defects in their families will suddenly be cause for alarm, and these laws will be changed.
Cuz this is entirely different from those whores on welfare getting abortions, you know.
@Ella in New Mexico: If that were to happen, all the legislators would do is change the laws to allow for abortion in the case of major fetal abnormality. Punishing the sluts in general would proceed apace.
@Ella in New Mexico:
Nah — everybody knows that only whores have sex (with their husbands who come down with visible Zika a few days afterwards), so nothing will be done. These are the same people who think married couples should stop having sex with each other if they don’t want more kids, so a preventable birth defect epidemic isn’t going to change their minds.
And getting extra welfare help to care for a kid with microcephaly? Should have thought of that before you decided to have sex with your husband, slut!
Ella in New Mexico
@Roger Moore: This is why some states, like Texas have tried to block the expansion of ‘tele-healthcare” which helps to provide healthcare providers to patients in remote locations by way of internet “Skype consulting”, particularly when it comes to abortion.
But from what I’ve read, the lucrative commercial aspects of it are overcoming the urge to obstruct abortion activities, fortunately, because God knows, when it comes to making money, even killing babies won’t keep Republicans in line. :-)
Somehow it had escaped my memory that the morning-after pill was now OTC…because for a while there, it wasn’t. So, d’oh!!
Ella in New Mexico
@Miss Bianca: Me neither!
Maybe we forgot because some of us, THANK YOU MERCIFUL BABY JEEBUS OF MENOPAUSE, may no longer be in the demographic that might need it?…:-)
So far, it has not been an issue, but you make a great point.
Unfortunately, international travel to potential problem areas is a concern as well. The Olympics, soccer events held overseas in areas where there might be problems. Now you have to count on local eradication efforts.
Adequate public health services is becoming a global problem.
ETA: Didn’t the pope relax restrictions on condom use in the wake of the Zika crisis? You have a supposedly rigid religious figure being more reasonable than conservative politicians in the US.
Also, has the question been put bluntly to any of the candidates in the presidential debate: “Candidate X, even though you opposed abortion, would you permit a woman who has been infected by the Zika virus to have an abortion to prevent the birth of a brain damaged child?”
@Ella in New Mexico:
The CDC and other public health entities have excellent info sections that detail the current knowledge base about Zika (who is at risk, how transmitted, symptoms, dangers, treatments, minimizing risks, etc.), but there appear still to be some of unknowns regarding the virus.
Here is a VERY shorthand version of commonly agreed info, as it relates to transmission and duration. Anyone who wants/needs additional or more in/depth info can find excellent resources on Zika at the CDC, NIH, PAHO/WHO, and state Board of Health sites, and can of course obtain in-depth info through their healthcare providers.
Primary vector is an Aedes species mosquito, and secondary in utero transmission from mother to fetus is documented.
However, since there is no documented evidence to date of Zika being transmitted via breastfeeding, both the CDC and the WHO guidelines state that currently, the benefits of breastfeeding outweigh any risk of possible transmission via breastfeeding.
There are reports in Brazil of Zika being acquired via blood transfusion. However, those reports are being investigated to try and confirm or refute blood transfusion as the method of transmission in those cases, according to the CDC.
Current research shows that the Zika virus usually remains in the blood of an infected person for approximately one to two weeks, but it has been found to remain longer in the blood of some patients. Both serogical tests (tests that look for disease-specific antibodies that the patient’s immune system has manufactured in order to fight the virus) and PCR blood tests (tests which identify the presence of the virus itself in the patient’s blood by identifying the virus’s DNA in the patient’s blood) can both be used to detect/help to confirm Zika virus infection, but since there can be antibody cross-reactivity to other viruses in the same viral family (known as flaviviruses – includes dengue fever and West Nile virus), serological (antibody) lab tests are not 100% reliable in diagnosing Zika as the cause of a patient’s symptoms.
Also, since a patient’s viral load decreaes over time as the body’s immune system attacks and begins eliminating the virus, PCR (DNA) tests are most useful during the first 5 days of the illness. After that time, the PCR test might come back false negative simply because the amount of virus present in the bloodstream is small enough that no virus was captured in that particular sample.
Because of this, the CDC states that performing both serologic and PCR testing, along with conducting a thorough patient history and clinical exam, is the best way to be certain of a Zika diagnosis.
Here’s where the waters get a little murkier.
Zika virus has also been documented to be present in the semen of infected men, and can be spread via semen to sexual partners. The virus can be spread via semen during the incubation phase of the virus (before symptoms appear), during the time that a man is actively symptomatic, and can remain present in the semen for an unknown amount of time after the man’s symptoms have cleared.
The virus has been documented to still be present in semen even after the patient’s immune system has cleared the virus from the patient’s blood.
Since researchers are not yet sure exactly how long the virus can remain present in semen after symptoms clear, the CDC guidelines state that male patients who have been diagnosed with Zika (or exhibited the symptoms of Zika) use condoms or abstain from sex for at least 6 months after the onset of the symptoms.
A couple of other unknowns that the CDC mentions:
– whether or not the virus can be spread via contact with other body fluids (saliva, urine, vaginal fluids, etc.etc). Interestingly, one study appearing in the January 2015 Journal of Emerging Infectious Diseases found that PCR testing detected the presence of Zika virus in the urine of Zika patients for more than ten days after the onset of the disease (longer than it was present in the bloodstream). (Emerg. Infect. Dis. 2025 Jan; 21(1): 84-86).
-whether or not an infected woman can spread the virus to her sexual partners
Hope this info is helpful in answering your question.
And, of course I left out the info most specific to your original question. Mea culpa, and apologies!
The CDC’s guidelines, as of March 25, 2016, state that, “women with Zika virus should wait until at least 8 weeks after symptom onset” before attempting to become pregnant. Women who have had a possible Zika exposure should “wait at least 8 weeks after the date of last exposure before attempting conception”, even if they showed no symptoms of having contracted Zika. The wait time for this second set of women is advised because of the enormous range of symptom severity in different people. Some people can be asymptomatic (no noticeable symptoms at all), some might have mild to moderate symptoms, while some might become very ill.
Since the virus can be transmitted via semen, and remains present in semen longer than in blood, CDC guidelines state that a man who has “had a diagnosis of Zika virus disease should wait at least 6 months after symptom onset before attempting conception”. Men who have had “possible Zika exposure without clinical illness… should wait at least 8 weeks after possible exposure before attempting conception.”
The CDC further states:
“Based on the available evidence, we think that Zika virus infection in a woman who is not pregnant would not pose a risk for birth defects in future pregnancies after the virus has cleared…”
@Origuy: The Zika virus is already in the US. We have it here in Hawaii.