Translation of a-t 2021; 52: 47-8
SIDE EFFECTS
ULIPRISTAL ACETATE (ESMYA) DESPITE HEPATOTOXICITY AGAIN ON THE MARKET
Ulipristal acetate (ESMYA), used to treat uterine fibroids, was withdrawn from the market in March 2020 as a result of serious liver damage including the need for a liver transplant (see a-t 2020; 51: 24).1 In September 2020, the pharmacovigilance committee PRAC of the European Medicines Agency (EMA) ultimately recommended that the authorisation be revoked, stating that it was not possible to identify patients who were at particular risk or to take measures to minimise the risk. The risks would therefore outweigh the benefits.2
The EMA's Committee for Medicinal Products for Human Use, however, did not follow the recommendation in November 2020. The benefits could outweigh the risks for women who did not have any other treatment options. 3 The preparation is now back on the market in Germany, but only as intermittent treatment of moderate to severe symptoms caused by uterine fibroids in premenopausal, adult women in whom embolization of the fibroids and surgery to remove them are not suitable or have failed.4
A "Dear Doctor Letter" sent in early February 2021 (in other words months before the reintroduction) provided information on the restriction of the authorisation and the extensive explanation that needs to be provided to women. According to the letter, five reports of liver damage with a liver transplant are now known.4 In France ulipristal is not available to treat fibroids any more as it is no longer reimbursed by the health insurance providers5 after the French health authority, HAS, found that the progesterone receptor modulator no longer had a role to play in the treatment strategy already in 2019.6 We also advise against the use of ulipristal to treat uterine fibroids in light of the potential damage, -Ed.
| 1 | Gedeon Richter: "Dear Doctor Letter" (Rote-Hand-Brief) of 23 March 2020; http://www.a-turl.de/?k=olmi |
| 2 | EMA: Press release of 4 September 2021; http://www.a-turl.de/?k=nzkl |
| 3 | EMA: Press release of 13 November 2021; http://www.a-turl.de/?k=allw |
| 4 | Accord Healthcare et al.: "Dear Doctor Letter" (Rote-Hand-Brief) of 1 February 2021; http://www.a-turl.de/?k=irow |
| 5 | Gedeon Richter: "Dear Doctor Letter" (Rote-Hand-Brief) of 23 March 2020; http://www.a-turl.de/?k=olmi |
| 6 | GHAS: Transparency Committee Opinion Summary, Febr. 2019; http://www.a-turl.de/?k=gglk |
© arznei-telegramm (Berlin/Germany), Juni 2021, protected by copyright laws.
Autor: Redaktion arznei-telegramm - Wer wir sind und wie wir arbeiten
Diese Publikation ist urheberrechtlich geschützt. Vervielfältigung sowie Einspeicherung und Verarbeitung in elektronischen Systemen ist nur mit Genehmigung des arznei-telegramm® gestattet.
