Ulipristal
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Liver failure secondary to liver injury: 4 case reports In a report, four women aged 45–58 years were described, who developed liver failure secondary to liver injury following treatment with ulipristal for uterine fibroid [not all indications and dosages stated]. These women were reported to the EMA via the French Pharmacovigilance network. Case 1: A 55-year-old woman developed started receiving oral ulipristal [Esmya; ulipristal acetate] on 11 July 2014. However, on the second day of treatment, she developed asthenia, fatigue, anorexia and post-prandial fullness. Ulipristal was discontinued on 24 October 2014. Thereafter, she was treated with cefuroxime for concurrent Klebsiella pneumoniae infection. She also received unspecified dietary supplements. Her medical history was significant for hepatitis A at the age of 18 years. Between 27 October 2014 to 1 November 2014, she was hospitalised due to acute hepatitis. On 7 November 2014, an ultrasound indicated probable hepatic steatosis. Serology was negative for hepatitis virus, HIV and autoimmunity. She was diagnosed with liver injury complicated by hepatic failure. The liver injury was suspected to be secondary to ulipristal therapy. On 12 December 2014, she underwent liver transplantation. Eventually, her clinical condition improved. Case 2: A 45-year-old woman started receiving oral ulipristal [Esmya; ulipristal acetate] on 28 June 2017. However, on the third day of therapy, she developed nausea, vomiting and asthenia. On 23 July 2017, she developed jaundice, and therefore, ulipristal was discontinued. Liver biopsy was non-typical for drug-induced hepatitis. Serology was negative for hepatitis virus, cytomegalovirus and HIV. On 26 July 2017, she was hospitalised. On 27 July 2017, a liver biopsy revealed predominant peri-portal necrosis. She was diagnosed with drug-induced liver injury complicated by liver failure. The liver injury was considered to be secondary to ulipristal therapy. On 22 August 2017, liver transplantation was performed. Further examination of the explanted liver revealed atrophy with massive necrosis and lymphocyte infiltration and cholestasis. Eventually, her clinical condition improved. Case 3: A 46-year-old woman received oral ulipristal [Esmya; ulipristal acetate] from November 2016 to 10 May 2017. On 20 May 2017, 10 days after ulipristal therapy completion, she developed weakness and anorexia. On 29 May 2017, she developed jaundice and cutaneous eruption with pruritus. Viral and immunological tests revealed negative results. She was hospitalised. Hepatic biopsy revealed necrosis area, portal fibrosis and steatosis. Liver fatty degeneration was noted. She developed exanthematic drug eruption due to ulipristal. Subsequently, she was diagnosed with liver injury complicated by acute liver failure, which was attributed to ulipristal therapy. She was hospitalised and underwent successful liver transplantation on 14 June 2017 and her clinical condition improved. However, she developed abdominal sepsis as complication of transplanted liver an
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