Adverse event report 001010083, Part II
Death of a young mother, thousands of children killed, and many more mothers harmed:
In our Adverse event report 001010083, Part I post, I mentioned Jenny or as she is better known to Health Canada Vigilance Reporting Office, #001010083. On February 28th I received a comprehensive response, and I want to share just a little with you today, because for the longest while I could not get past the first few sentences of the communication. I have repeated the main sentence below and broken it down in two segments to highlight my thoughts in this post. I was stuck here because what it says to me is, that if the Product Monograph states that an adverse event may happen even “rarely’, that is enough to assume that the individual had seen it and decided to take the risk anyway. What a massive leap to make!
I wish to make a couple of points, and then ask you to ponder directly how on earth any of the women who take Mifegymiso can possibly be expected, without medical background, to decide if they have an infection, with or without fever, or whether the symptoms they are experiencing are just the reactions mentioned in the Adverse Reactions Overview?
Are we to believe that every woman has read the 39 page Mifegymiso Product Monograph or the 11 page Patient Brochure, or possibly just the 9 page Patient Medication Information or perhaps just pages 5/6/9/10 and 31, and somehow gained the knowledge to differentiate what is normal to expect after administering the drug cocktail to themselves, or whether their symptoms are a sign of a life threatening event? I do not believe that by having stated a fatal adverse event, although rare, may occur, is enough to let Linepharma, our Governments nor those who support, prescribe or dispense these drugs, off the hook for the harm and in Jenny’s case her unnecessary death from septic shock.
About Your Concerns
For an overview of what we do with the reports we receive, please see the “What we do with reports” section below. Please note adverse reaction (AR) reports with a fatal outcome undergo a similar process; however, we prioritize them. Additionally, fatal reports don’t automatically translate into further regulatory measures, especially if the AR leading to the death is already listed in the Product Monograph. A copy of the Mifegymiso product monograph can be found at this link here, where Pages 5-6 contains information on some serious warnings and precautions when patients take this medication. The risk of infection and sepsis, has been included in this section. It states, “Cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of Mifegymiso”. In addition, measures to mitigate the risk of sepsis are described on Pages 9 -10 under the subheading of Infection under the Warning and Precaution section”.
“…..Please note adverse reaction (AR) reports with a fatal outcome undergo a similar process; however, we prioritize them. Additionally, fatal reports don’t automatically translate into further regulatory measures, especially if the AR leading to the death is already listed in the Product Monograph…….”
“…fatal reports don’t automatically translate into further regulatory measures, especially if the AR leading to the death is already listed in the Product Monograph…….”
“…especially if the AR leading to the death is already listed in the Product Monograph…….”
The information above is on page 31 of the Product Monograph and page 31-39 constitute the Patient Medication Information on the Linepharma website.
On Page 35 and 36 women are informed of the possible side-effects from using Mifegmiso and it states
These are not all the possible side effects you may have when taking Mifegymiso. If you experience any
side effects not listed here, tell your healthcare professional.
Side effects may include:
− breast tenderness
− hot flushes, chills
− diarrhea
− dizziness, headache, fainting
− fatigue
− nausea
vomiting
Patients who are less than 18 years old often get more vomiting and pain.
These side effects slow down after Day 3 and are usually gone by Day 14. Your health professional will
tell you how to manage any pain or other side effects.
Will someone please tell me how young women, who are unexpectedly pregnant, and looking for a quick way out via chemical abortion – will be able to understand the difference between what is normally expected and what might be life-threatening given the information above and what follows, after this article?
We know that access to Mifegymiso is expanding, while professional medical involvement is decreasing. Where are the ethical medical professionals, government officials, or women’s groups now? How many more 001010083 reports do we have to see alongside the thousands of tiny childrens’ deaths, before someone is held accountable to ensure that women really understand what they are considering? We already know that their knowledge of fetal development is practically nil, and so their child dies, but now this ignorance without ethical professional counselling and guidance places their own life at risk.
It really is not good enough.
