Conception

5 days after pill: no prescription needed but is it really a contraceptive?

Adult women can ask for the 5 days later pill at the ellaOne pharmacy. The prescription requirement remains for minors.

In a nutshell, this is what was published in the Official Gazette on 8 May 2015.

But what you have read in the newspapers is not completely true and here we try to clarify things a bit, always in the name of conscious choices.

What is EllaOne

It is a drug that has ulipristal acetate as its active ingredient. It is part of what are called emergency contraceptives (like   levonorgestrel aka the morning after pill ). The leaflet states that it must be taken within 120 hours of risky intercourse (unprotected or because the contraceptive used has failed in its task such as when a condom breaks).

Ulipristal acetate binds to receptors that would normally bind progesterone, inhibiting the action of the hormone.

The EMA : European Medicines Agency declares that “through its action on progesterone receptors, ellaOne prevents the establishment of pregnancy mainly by preventing or delaying ovulation. If ovulation has already taken place, ellaOne is no longer effective”.

So far everything seems clear but it is not.

In fact, one would be led to think that this drug is going to prevent conception.

Therefore, I would like to better explain the functioning mechanism of this drug because I find it correct that those who decide to take it know what they are getting into.

Correct information is not obtained by hiding things or explaining them halfway.

EllaOne and the half truth

The process that led to the “liberalisation” of ellaOne was very complex and tortuous as there were important issues to be clarified.

The EMA released the marketing authorization for the drug in the European Union on 15 May 2009. On 7 January 2015, the European Commission accepted the EMA’s request to convert the drug from a prescription-only medicine to a medicine   not subject to medical prescription. In the contraindications of the medicine, the pregnancy in progress was contextually eliminated.

Before deciding whether to adopt the same path as the EMA, AIFA asked the Superior Health Council to express itself on the matter and make its assessments which were published on 10 March 2015. This document contains very important question marks and requests very precise which apparently have not been examined by AIFA which has in any case given the go-ahead for the sale of ellaOne without a prescription to adult women.

I reproduce below some important points while for the reading of the document in its entirety I refer you here:  session of the Superior Health Council: opinion on ellaOne

The document states that ellaOne must be administered from the moment in which the LH hormone begins to rise and therefore in the 30-36 hours preceding the peak for it to have maximum effectiveness in blocking ovulation. When the LH hormone has reached its peak and ellaOne is taken at this juncture, its ovulation-blocking effect decreases dramatically.

And how does a woman know exactly when she’s had her peak especially if she’s not trying to get pregnant?

Furthermore, current studies on the effect on the endometrium cannot exclude an anti-dairy action, ie that of going to prevent any embryo conceived from nesting in the uterus.

The Superior Health Council in the light of this information, namely:

  • doubt about the real working mechanism
  • risk of frequent intake which could endanger the health of the woman
  • risk that this drug could further decrease the use of valid hormonal contraceptives or mechanical contraceptives that prevent sexually transmitted diseases,

requested the prescription of the drug regardless of the age of the applicant.

Despite this, AIFA preferred not to listen to the CSS questioned and to approve the sale without a prescription to adult women.

Right or wrong?

It’s not up to me to say even if it is clear, as stated on the Sipre website  that

AIFA continues to deny the population and Doctors the right to know what type of action the drug has: whether to prevent ovulation and conception, or to suppress a child already conceived […] knowledge of the data is prerequisite – essential condition of a free and personal choice […] AIFA, two months after the publication of the Opinion of the CSS, has not yet corrected the information leaflet of the drug which contains untruthful information that conflicts with the Opinion of the CSS.

When it comes to medicines, whether they are those in common use, whether they are vaccines or pills of various kinds, I believe that citizens have the right to know their effects, contraindications and the correct methods of taking them in order to be able to make an informed choice .

Dr Kathryn Barlow

Kathryn Barlow is an OB/GYN doctor, which is the medical specialty that deals with the care of women's reproductive health, including pregnancy and childbirth.

Obstetricians provide care to women during pregnancy, labor, and delivery, while gynecologists focus on the health of the female reproductive system, including the ovaries, uterus, vagina, and breasts. OB/GYN doctors are trained to provide medical and surgical care for a wide range of conditions related to women's reproductive health.

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