About: Suspension of ulipristal acetate for uterine fibroids during ongoing EMA’s review of liver injury risk: Unfortunate timing during the Covid-19 pandemic!

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About: Suspension of ulipristal acetate for uterine fibroids during ongoing EMA’s review of liver injury risk: Unfortunate timing during the Covid-19 pandemic! Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Suspension of ulipristal acetate for uterine fibroids during ongoing EMA’s review of liver injury risk: Unfortunate timing during the Covid-19 pandemic!
Creator	Vandromme, Jean Rozenberg, Serge Bucella, Dario Fastrez, Maxime Revercez, Perrine
Source	Elsevier; Medline; PMC
abstract	OBJECTIVE: EMA decided that with ulipristal acetate (UPA) treatment for uterine fibroids, should be discontinued due to the associated risk of hepatic failure, We analyzed whether the risk of recurrent symptoms due to fibroids may lead to an increased risk of Covid -19 infection and death, that would exceed the former risk of hepatic failure and transplantation. STUDY DESIGN, SIZE, DURATION: We used a Markov model to generate probabilities. PARTICIPANTS/MATERIALS, SETTING, METHODS: There are currently about 36250 treated patients in Europe. We estimated bleeding probabilities, while using or discontinuing UPA, which may induce a need of medical or surgical management in symptomatic patients, and increase the risk of acquiring a Covid-19 infection, and die from it. We also estimated the risk of suffering a hepatic failure and hepatic transplantation. MAIN RESULTS AND THE ROLE OF CHANCE: Based on our assumptions, ceasing UPA during a Covid 19 pandemic may be associated with a fatality ratio between 4 and 18, due to the Pandemic, whereas pursuing UPA would be associated with a fatality rate due to the pandemic between 1-2, and an added fatality rate due to hepatic impairment of 1. The added risk of stopping UPA may range between 2 and 15 additional deaths. Our calculations suggest that the decision to stop UPA in the middle of the Covid- 19 pandemic may be untimely, since it may result in an increased risk of Covid-19 infection, due to the recurrence of symptoms and the need for medical and surgical treatment. WIDER IMPLICATIONS OF THE FINDINGS: A decision, like the one EMA took need to be taken in a wider health context of a population, than simply analyzing its role as regulating agent for medications. STUDY FUNDING/COMPETING INTEREST(S): The study was not funded/ There are no competing interests.
has issue date	2020-06-27(xsd:dateTime)
bibo:doi	10.1016/j.ejogrb.2020.06.064
bibo:pmid	32650189
has license	no-cc
sha1sum (hex)	23c38241fcf0a5cdf341d937adb575f6758b0ace
schema:url	https://doi.org/10.1016/j.ejogrb.2020.06.064
resource representing a document's title	Suspension of ulipristal acetate for uterine fibroids during ongoing EMA’s review of liver injury risk: Unfortunate timing during the Covid-19 pandemic!
has PubMed Central identifier	PMC7320679
has PubMed identifier	32650189
schema:publication	Eur J Obstet Gynecol Reprod Biol
resource representing a document's body	covid:23c38241fcf0a5cdf341d937adb575f6758b0ace#body_text
is schema:about of	named entity 'fibroids' named entity 'LEAD' named entity 'decided' named entity 'Covid' named entity 'hepatic failure' named entity 'ulipristal acetate' named entity 'Covid-19 pandemic' named entity 'ulipristal acetate' named entity 'discontinued' named entity 'infection' named entity 'virulence' named entity 'renal function' named entity 'anemia' named entity 'Covid 19 pandemic' named entity 'liver' named entity 'March 13, 2020' named entity 'European Medicines agency' named entity 'infection' named entity 'Corona pandemic' named entity 'hepatic impairment' named entity 'COVID-19' named entity 'infection' named entity 'Corona-virus' named entity 'hysteroscopy' named entity 'infection' named entity 'mortality rates' named entity 'comorbidities' named entity 'surgical procedure' named entity 'EMA' named entity 'Italy' named entity 'oxygen' named entity 'medical therapy' named entity 'risk of death' named entity 'anemic' named entity 'infection' named entity 'Hepatic' named entity 'healthcare industry' named entity 'asymptomatic' named entity 'surgical mortality' named entity 'fibroids' named entity 'Markov model' named entity 'Amgen' named entity 'Europe' named entity '0.01' named entity 'anemic' named entity 'immune response' named entity 'fatality rate' named entity 'death rate' named entity 'infection' named entity 'fibroids' named entity 'fatality rate' named entity 'fibroids' named entity 'anemia' named entity 'safety committee' named entity 'asymptomatic' named entity 'risk of death' named entity 'myomectomy' named entity 'blood disease' named entity '2.2' named entity 'probability' named entity 'COVID-19' named entity 'ulipristal acetate' named entity 'iron-deficiency' named entity 'surgical treatment' named entity 'infection' named entity 'prospective cohort study' named entity 'fibroid' named entity 'health care' named entity 'uterine fibroids' named entity 'iron metabolism' named entity 'menorrhagia' named entity 'Ulipristal Acetate' named entity 'mortality rates' named entity 'Uterine leiomyomas' named entity 'hepatic impairment' named entity 'liver' named entity 'fibroid'

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