<img src = "https://media.npr.org/assets/img/2018/11/13/mifepristone-2_sq-1ea5573128a2f059a11038bf3b62158837e22e12-s100-c15.jpg" data-original = "https: // media .npr.org / assets / img / 2018/11/13 / mifepristone-2_sq-1ea5573128a2f059a11038bf3b62158837e22e12-s100.jpg "class =" img lazyOnLoad "alt =" A drug that relieves miscarriage is hard to find for women  " I think the FDA has shown its willingness to … take action, "Henney says," I think it's important that they re-examine in the light of the safety information we know about this drug. " The interview has been reviewed for clarity and brevity.
What prompted the decision to restrict mifepristone as early as 2000? The drug was approved and the clinical data reviewed by the FDA at that time came from mostly from experiences outside Europe, especially from France, where they were used. And since there was not so much experience [in the U.S] with the product, the limitations were set so that we could provide it and at the same time monitor what would happen after this [in terms of] risk of surgical abortion, side effects or side effects ,
Over the course of these 19 years, we have learned a lot about this drug and found that its side effects are reasonably low and can be handled well. There are occasional side effects, just like any other prescription drug. But putting it into this restricted distribution does not seem to be [necessary]according to the information we know at least now. And indeed it is pretty annoying.
How have these initial limitations changed?
What could be the impact of lifting some of these restrictions on women?
Current restrictions put a lot of strain on women who need to go to a clinic and [on] the certified doctor. If some of these restrictions are removed, you may be able to consult your own doctor, who may issue you a prescription to fill your pharmacy and take this medicine at home. Women, especially in rural areas and suburbs, have to travel long distances and it is only a real burden for them to do so. It is also a burden for the doctors who need to register and keep extensive records.
I think these restrictions on the delivery of mifepristone may make women seek these products over the Internet. And there's a real risk, I think. They can not be sure that they have the same safety profile or the same quality, and there is a real risk that the product they would receive has an even higher risk profile or that it is a non-efficacious product at all and will not work.
If the current restrictions were re-examined, what could change?
Well, that would really be how the FDA checked this and what changes they would make. You can imagine that this system is widely used from the maintenance to the manufacture of a prescription product that doctors can prescribe and which is filled by a pharmacist. There are many other products in the REMS category. [For] More than half, I would say, all that is required is that the patient receives a medication guide. Mifepristone has almost the most restrictive distribution system of these products. The FDA, after reviewing all available data, is able to decide whether mifepristone really needs to be restricted that much at this point.
What would you say to people who argue that in some women mifepristone carries the risk of serious complications and should remain strictly regulated?
I would just say that as with many prescription drugs, there are risks. But the risks with mifepristone are well known and it is still prescription. Therefore, a doctor must prescribe the drug and he has a black box warning to make sure that the doctor informs the patient about risks, the serious ones of which are quite rare. They can include heavy bleeding, abdominal pain or fever. And when a patient experiences this, he goes back and contacts his doctor for further treatment. I would also say that the risk of medical mifepristone discontinuation is much lower than surgical removal and much lower than for women who are prone to pregnancy. I think we are talking about serious adverse events that can occur. They are extremely rare; they are known and treatable.
Some also argue that abortion can cause a prolonged emotional trauma and that prescriptions about medication could protect women – what do you say?
I would say that women make a serious decision about whether they have an abortion or not. And I think that one has to weigh the serious consequences of pregnancy and the trauma that often accompanies it against some psychological experiences that some patients might have. But I think most women take this decision very seriously. They often do it in consultation with their doctor. And I think it offers them the opportunity to do what they know best.
Luisa Torres is an AAAS Fellow for Mass Media at the NPR's Scientific Desk. She is on Twitter at @luisatorresduq .