Ondansetron in pregnancy revisited: Assessment and pregnancy labelling by the European Medicines Agency (EMA) & Pharmacovigilance Risk Assessment Committee (PRAC)

2020 ◽  
Author(s):  
Per Damkier ◽  
Yusuf Cem Kaplan ◽  
Svetlana Shechtman ◽  
Orna Diav‐Citrin ◽  
Matteo Cassina ◽  
...  
Keyword(s):  
Risk Assessment ◽  
European Medicines Agency ◽  
Pharmacovigilance Risk Assessment Committee ◽  
Assessment Committee ◽  
In Pregnancy

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

scholarly journals A Quantitative Benefit–Risk Analysis of ChAdOx1 nCoV-19 Vaccine among People under 60 in Italy

Vaccines ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 618
Author(s):  
Raffaele Palladino ◽  
Daniele Ceriotti ◽  
Damiano De Ambrosi ◽  
Marta De Vito ◽  
Marco Farsoni ◽  
...  
Keyword(s):  
Risk Analysis ◽  
Sinus Thrombosis ◽  
Age Groups ◽  
Cerebral Venous Sinus Thrombosis ◽  
European Medicines Agency ◽  
Uncertainty Interval ◽  
R Ratio ◽  
Pharmacovigilance Risk Assessment Committee ◽  
Assessment Committee ◽  
Excess Number

The Oxford-AstraZeneca ChAdOx1 nCoV-19 is a vaccine against the COVID-19 infection that was granted a conditional marketing authorization by the European Commission in January 2021. However, following a report from the Pharmacovigilance Risk Assessment Committee (PRAC) of European Medicines Agency, which reported an association with thrombo-embolic events (TEE), in particular disseminated intravascular coagulation (DIC) and cerebral venous sinus thrombosis (CVST), many European countries either limited it to individuals older than 55–60 years or suspended its use. We used publicly available data to carry out a quantitative benefit–risk analysis of the vaccine among people under 60 in Italy. Specifically, we used data from PRAC, Eudravigilance and ECDC to estimate the excess number of deaths for TEE, DIC and CVST expected in vaccine users, stratified by age groups. We then used data from the National Institute of Health to calculate age-specific COVID-19 mortality rates in Italy. Preventable deaths were calculated assuming a 72% vaccine efficacy over an eight-month period. Finally, the benefit–risk ratio of ChAdOx1 nCoV-19 vaccination was calculated as the ratio of preventable COVID-19 deaths to vaccine-related deaths, using Monte-Carlo simulations. We found that among subjects aged 20–29 years the benefit–risk (B-R) ratio was not clearly favorable (0.70; 95% Uncertainty Interval (UI): 0.27–2.11). However, in the other age groups the benefits of vaccination largely exceeded the risks (for age 30–49, B-R ratio: 22.9: 95%UI: 10.1–186.4). For age 50–59, B-R ratio: 1577.1: 95%UI: 1176.9–2121.5). Although many countries have limited the use of the ChAdOx1 nCoV-19 vaccine, the benefits of using this vaccine clearly outweigh the risks in people older than 30 years. Study limitations included risk of underreporting and that we did not provide age-specific estimates. The use of this vaccine should be a strategic and fundamental part of the immunization campaign considering its safety and efficacy in preventing COVID-19 and its complications.

scholarly journals Analysis of Thrombotic Adverse Reactions of COVID-19 AstraZeneca Vaccine reported to EudraVigilance database

2021 ◽  
Author(s):  
Mansour Tobaiqy ◽  
Hajer Elkout ◽  
Katie MacLure
Keyword(s):  
Adverse Reactions ◽  
Blood Clot ◽  
Descriptive Study ◽  
World Health ◽  
European Medicines Agency ◽  
Research Groups ◽  
Spontaneous Reports ◽  
Pharmacovigilance Risk Assessment Committee ◽  
Assessment Committee ◽  
Health Organization

The development of safe, effective, affordable vaccines against COVID-19 remains the cornerstone to mitigating this pandemic. Early December 2020, multiple research groups had designed potential vaccines. From 11 March 2021, several European countries temporarily suspended the use of the Oxford-AstraZeneca vaccine amid reports of blood clot events and death of a vaccinated person, despite the European Medicines Agency and the World Health Organization assurance that there was no indication that vaccination was linked. This study aimed to identify and analyse the thrombotic adverse reactions associated with Oxford-AstraZeneca vaccine. This was a retrospective descriptive study using spontaneous reports submitted to the EudraVigilance database in the period from 17 February to 12 March 2021. There were 54,571 adverse reaction reports of which 28 were associated with thrombotic adverse reactions. Three fatalities were related to Pulmonary Embolism and 1 fatality to Thrombosis. With 17 million people having had the AstraZeneca vaccine, these are extremely rare events. The EMA Pharmacovigilance Risk Assessment Committee (18 March 2021) concluded that the vaccine was safe, effective and the benefits outweighed the risks. Conducting further analyses based on more detailed thrombotic adverse event reports, including patients characteristics and comorbidities, may enable assessment of the causality with higher specificity.

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

scholarly journals Analysis of Thrombotic Adverse Reactions of COVID-19 AstraZeneca Vaccine Reported to EudraVigilance Database

Vaccines ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 393
Author(s):  
Mansour Tobaiqy ◽  
Hajer Elkout ◽  
Katie MacLure
Keyword(s):  
Adverse Reactions ◽  
Blood Clot ◽  
Descriptive Study ◽  
World Health ◽  
European Medicines Agency ◽  
Research Groups ◽  
Spontaneous Reports ◽  
The World ◽  
Pharmacovigilance Risk Assessment Committee ◽  
Assessment Committee

The development of safe, effective, affordable vaccines against COVID-19 remains the cornerstone to mitigating this pandemic. Early in December 2020, multiple research groups had designed potential vaccines. From 11 March 2021, several European countries temporarily suspended the use of the Oxford–AstraZeneca vaccine amid reports of blood clot events and the death of a vaccinated person, despite the European Medicines Agency (EMA) and the World Health Organization’s assurance that there was no indication that vaccination was linked. This study aimed to identify and analyse the thrombotic adverse reactions associated with the Oxford–AstraZeneca vaccine. This was a retrospective descriptive study using spontaneous reports submitted to the EudraVigilance database in the period from 17 February to 12 March 2021. There were 54,571 adverse reaction reports, of which 28 were associated with thrombotic adverse reactions. Three fatalities were related to pulmonary embolism; one fatality to thrombosis. With 17 million people having had the AstraZeneca vaccine, these are extremely rare events The EMA’s Pharmacovigilance Risk Assessment Committee (18 March 2021) concluded that the vaccine was safe, effective and the benefits outweighed the risks. Conducting further analyses based on more detailed thrombotic adverse event reports, including patients’ characteristics and comorbidities, may enable assessment of the causality with higher specificity.

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