I write to correct the mis-information stated by Mozzanega (TMIS, 13 December) regarding the mode of action of EllaOne (ulipristal acetate) which is licensed in Malta, as in the rest of the EU, for use as emergency contraception. Here I refer directly to the updated European Public Assessment Report (EPAR) published by the European Medicines Authority dated 26 May.
Based on extensive literature published in respected peer reviewed mainstream journals (available upon request), the EPAR states unequivocally that EllaOne works by stopping or delaying ovulation and hence preventing fertilization. The best available evidence is that EllaOne does not prevent implantation, and if ovulation has already occurred, EllaOne is no longer effective. At a dose of 30mg, it is highly effective and well-tolerated and has been marketed for use as emergency contraception in Europe since 2009. It is available without prescription in Malta, as in most of the EU. Sadly, some pharmacists in Malta persist in quoting conscientious objection as justification for not dispensing this safe medicine.
There is no evidence that EllaOne can interrupt an existing pregnancy. Contrary to the conspiracy theories propounded by my esteemed colleague, the 2020 updated EPAR clearly states that the reason that pregnancy is a contraindication for EllaOne is that there is not enough animal data to reassure us that it is not toxic to the reproductive system. Although limited human data regarding pregnancy after EllaOne does not suggest any safety concerns, it is important that all cases be reported to www.hra-pregnancy-registry.com
My colleague insinuates maleficence in the 2009 EMA Assessment Report statement “to omit any sentence suggesting that the product could be used as an abortifacient”. Quite the contrary, the interpretation becomes clearer when one reads the May EPAR report. It literally means that there should not be any reference that it can be used as an abortifacient, simply because it is not.
The icing on the misinformation cake is the allegation that because EllaOne and Emysa contain the same active ingredient, and the FDA has refused to approve Esmya because of liver injuries, then women should be worried about similar issues when taking EllaOne. Yes, both EllaOne and Esmya contain ulipristal acetate but the similarities between them begin and end with the chemical compound they share, as they are very different when it comes to how they are used. A single 30mg EllaOne pill taken within five days of having unprotected sex is effective at stopping ovulation. Although it can be taken on multiple occasions in the case of multiple slip-ups, it is not designed for continuous use.
Esmya, on the other hand, is a medication intended to shrink uterine fibroids which are growths in the muscle tissue of the uterus that often cause heavy bleeding. It was approved at a 5mg dosage by the European Medicines Authority and is intended for continuous use. That means that, while one EllaOne pill is a higher dose than one Esmya pill, Esmya’s cumulative dose is much higher. This is true whether Esmya is taken for a few months before surgery, as it was initially approved, or taken long-term. Because of this, patients taking Esmya have a very different risk of complications than those taking EllaOne. Data collected by the European Medicines Authority supports EllaOne’s safety and efficacy as an emergency contraceptive. Your readers should also know that there is no difference in the number or seriousness of side effects in overdoses of up to 200mg (that is, six times higher than one EllaOne tablet). Claims that EllaOne is dangerous are extremely exaggerated.
In issuing the marketing authorisation for emergency contraception, the Medicines Authority in Malta drew upon the analysis of research data of thousands of experts throughout the EU. The system is designed to protect consumers from incomplete information and warped logic.
On one point alone I do agree with my esteemed colleague: scientifically correct information should be made available to doctors, pharmacists, consumers and politicians. May I therefore suggest that he forwards any evidence that emergency contraception interferes with fertilization and implantation to the European Medicines Authority. Let us see if they change their position. I very much doubt it.
Professor Stabile is writing on behalf of Doctors for Choice, Malta