Ulipristal acetate and liver-injuries: while Esmya is revoked, EllaOne is allowed in repeated self-administrations possibly exceeding UPA toxic-dosing with Esmya

Mozzanega, Bruno

doi:10.1016/j.jhep.2020.11.041

Cited by 6 publications

(4 citation statements)

References 5 publications

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“…Recently, the mechanisms (if any) involved in UPA as a DILI trigger are being attentively reviewed 7,18–20 but very far from being clearly understood. They are probably of an idiosyncratic nature, but they can also be dose dependent and related to the formation of reactive metabolites at the hepatic level, accumulation of UPA and/or its metabolites due to their long half‐life and high lipophilicity, inhibition of liver transporters, and previous cirrhosis caused by alcohol abuse or chronic viral infection, which may predispose patients to cholestatic disease that decreases biliary excretion 7,19–23 …”

Section: Discussionmentioning

confidence: 99%

Acute liver failure requiring transplantation: A possible link to ulipristal acetate treatment?

Dinis-Oliveira

Vieira

2021

Basic Clin Pharma Tox

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The present case describes in detail a 55‐year‐old woman diagnosed with acute liver injury 3 days after completion of the first treatment course with ulipristal acetate (UPA), 5 mg/day orally for uterine fibroids causing persistent bleeding (treatment duration of 109 days). Liver transplantation was performed approximately 6 weeks after UPA suspension, and a photograph of the explanted liver is presented. Of note, other common causes of acute liver injury, such as history of alcohol or other psychoactive substances abuse, viral hepatitis and autoimmune hepatitis or preexisting liver disease were all excluded. This case was reported to the European Medicines Agency (EMA) and contributed to the final recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) disclosed in January 2021. The causality assessment considered a probable case of drug‐induced liver injury as a consequence of UPA treatment, and the Roussel Uclaf Causality Assessment Method (RUCAM) was scored as unlikely. Although further studies are needed aiming to avoid confounding factors, this case suggests that liver function tests should be monitored during treatment with UPA.

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Section: Discussionmentioning

confidence: 99%

Acute liver failure requiring transplantation: A possible link to ulipristal acetate treatment?

Dinis-Oliveira

Vieira

2021

Basic Clin Pharma Tox

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“…The use of these agents before a planned surgery allows patients to have a minimally invasive route for surgery and smaller incisions and improves preoperative anemia and perioperative outcomes [7]. Although progesterone receptor modulators are also highly effective medical therapy, the hepatotoxicity seen with ulipristal acetate has made these agents unavailable for fibroid care in the United States and significantly limited their use elsewhere [8].…”

Section: Medical Management: Traditional Optionsmentioning

confidence: 99%

New treatment options for nonsurgical management of uterine fibroids

Lee

Stewart

2023

Current Opinion in Obstetrics &Amp; Gynecology

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Purpose of reviewUterine fibroids is a common problem in reproductive-age individuals, frequently causing abnormal uterine bleeding, bulk symptoms, and adverse reproductive outcomes. Traditionally, almost half of the women with symptomatic fibroids received surgery for definitive treatment. There are a growing number of nonsurgical options for treatment that have become available for patients who desire conservative treatment or those with contraindications to surgery. Recent findingsThe introduction of oral gonadotropin-releasing hormone antagonists in combination with low-dose physiologic hormonal therapy demonstrated improvement in heavy menstrual bleeding, pain, and quality of life with preservation of bone density and a modest reduction in uterine volume with few hypogonadal side effects. Magnetic resonance-guided focused ultrasound surgery and uterine artery embolization continue to be minimally invasive procedural alternatives to hysterectomy that are safe and effective.

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“…While this is not likely with a single dose of UPA 30 mg there is some concern over instances of repeated doses of UPA 30 mg. For this reason, there is concern where it may be available without prescription and used repeatedly or even where it is prescribed repeatedly. 52…”

Section: Clinical Evaluationmentioning

confidence: 99%

“…There is both a lost opportunity to provide a more effective emergency contraceptive method which is a LARC, and so unintended pregnancy still remains a future threat, and there is also the possibility that repeated use of UPA may be harmful. 52 A confirmation of the LNG-IUD study 94 and establishing whether the LNG-IUS 13.5mg and LNG-IUS 19.5mg can operate as emergency contraception is a priority. This will be difficult to accomplish.…”

Section: Determination Of An Emergency Contraceptive Agent As a Contr...mentioning

confidence: 99%

Emergency contraception from historical myth to modern reality: a historical timeline and updated interpretation

Goldstuck

2022

F1000Res

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Introduction: Emergency contraception is the use of a birth control method after coitus has taken place and there is a fear that it may lead to a pregnancy. Historical attempts were more likely to be harmful rather than effective. Oral estrogens, progestins, anti-progesterone, and partial agonist/antagonists of progesterone have all been used with varying degrees of efficacy. Currently ethinyl estradiol/levonorgestrel combinations, levonorgestrel alone, ulipristal acetate, and mifepristone are the usual oral methods depending on availability. Copper carrying and more recently levonorgestrel releasing intrauterine devices have also been used successfully. The intrauterine devices appear to be more effective than the oral methods and are also regular contraceptive methods and in addition have therapeutic properties. Background: The evolution from longer duration oral treatments with side effects to the current single tablet of levonorgestrel, ulipristal acetate, or mifepristone with low side effects and reasonable efficacy is described. The role of the highly effective copper intrauterine device and now also the levonorgestrel intrauterine device for emergency contraception is examined. Conclusion: Oral emergency contraception is a short term solution. Expanding emergency contraception to include the levonorgestrel releasing intrauterine device may provide long term contraception and health benefits as well as providing emergency contraception.

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Ulipristal acetate and liver-injuries: while Esmya is revoked, EllaOne is allowed in repeated self-administrations possibly exceeding UPA toxic-dosing with Esmya

Abstract: Please cite this article as: Mozzanega B, Ulipristal Acetate and liver-injuries: while Esmya is revoked, EllaOne is allowed in repeated self-administrations possibly exceeding UPA toxic-dosing with Esmya.,

Cited by 6 publications

References 5 publications

Acute liver failure requiring transplantation: A possible link to ulipristal acetate treatment?

Acute liver failure requiring transplantation: A possible link to ulipristal acetate treatment?

New treatment options for nonsurgical management of uterine fibroids

Emergency contraception from historical myth to modern reality: a historical timeline and updated interpretation

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