New safety signals assessed by the Pharmacovigilance Risk Assessment Committee at EU level in 2014–2017

2018 ◽  
Vol 11 (10) ◽  
pp. 1045-1051 ◽  
Author(s):  
Andrea Farcaş ◽  
Andreea Măhălean ◽  
Noémi Beátrix Bulik ◽  
Daniel Leucuta ◽  
Cristina Mogoșan
Keyword(s):  
Risk Assessment ◽  
Pharmacovigilance Risk Assessment Committee ◽  
Assessment Committee ◽  
Safety Signals

Current conservative treatment of uterine fibroids. Ulipristal acetate and liver damage: contrived tragedy?

GYNECOLOGY ◽  
2018 ◽  
Vol 20 (6) ◽  
pp. 4-7
Author(s):  
A L Tikhomirov
Keyword(s):  
Risk Assessment ◽  
Liver Injury ◽  
Liver Damage ◽  
Uterine Fibroids ◽  
Tumor Formation ◽  
Drug Induced ◽  
Ulipristal Acetate ◽  
Drug Induced Liver Injury ◽  
Pharmacovigilance Risk Assessment Committee ◽  
Assessment Committee

Uterine fibroids are the most common pelvic tumor formation in women and the most common indication for hysterectomy. The effectiveness of long-term intermittent use of ulipristal acetate (UA) in patients with uterine myoma has been proven earlier. In May 2018, the ability of UA to cause a drug-induced liver injury (drug-induced liver injury, DILI) was disproved, and the European Commission approved a positive decision. According to the conclusion Expertise of the Pharmacovigilance Risk Assessment Committee (Pharmacovigilance Risk Assessment Committee - PRAC) the benefit/risk ratio remains favorable. Published recommendations are aimed at reducing the risk of liver damage. UA remains the 1st line of treatment for most myomas.

PS-065 Ivabradine prescription according to pharmacovigilance risk assessment committee restrictions

2016 ◽  
Vol 23 (Suppl 1) ◽  
pp. A242.1-A242
Author(s):  
J Marco del Río ◽  
A Valladolid Walsh ◽  
S Plata Paniagua ◽  
L Victorio García ◽  
G Romero Candel ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Pharmacovigilance Risk Assessment Committee ◽  
Assessment Committee

A Description of Signals During the First 18 Months of the EMA Pharmacovigilance Risk Assessment Committee

Drug Safety ◽  
2014 ◽  
Vol 37 (12) ◽  
pp. 1059-1066 ◽  
Author(s):  
Alexandra C. Pacurariu ◽  
Preciosa M. Coloma ◽  
Anja van Haren ◽  
Georgy Genov ◽  
Miriam C. J. M. Sturkenboom ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Pharmacovigilance Risk Assessment Committee ◽  
Assessment Committee
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