Adverse drug effects

Adverse Drug Reactions

Management of Adverse Effects

SERAPHIN study

SERAPHIN - STUDY WITH ENDOTHELIN RECEPTOR ANTAGONIST IN PULMONARY ARTERIAL HYPERTENSION TO IMPROVE CLINICAL OUTCOME. SERAPHIN (Study with an Endothelin Rece...

Venous Arterial Thromboembolism

Thrombosis is the formation of a blood clot inside a blood vessel, blocking a vein (venous thrombosis) or artery (arterial thrombosis). Venous Arterial Thromboembolism (VAT) is caused when some or a...

Pharmacovigilance: Databases Support Adverse Event Reporting

Drug companies’ increased pharmacovigilance activities highlight the importance of both clinical data and adverse events reporting.  The World Health Organization (WHO) estimates that adverse drug...

Pharmacovigilance Risk Assessment Committee (PRAC) Present At SMi's 3rd Annual Event On Pharmacovigilance, London UK

In recent weeks, The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended restrictions in the use of strontium ranelate (Protelos/Osseor) to reduce...

EMA adverse event probe, with teeth, may threaten Roche drugs worth $28bn

The European Medicines Agency announced on 23 October that it will begin to investigate Roche’s alleged non-compliance with pharmacovigilance obligations concerning 19 of its most prominent drug...

Anvisa stresses importance of pharmacovigilance and international collaboration

Brazilian drug regulator Anvisa has called for increased pharmacovigilance and more effective reporting of adverse reactions by authorities worldwide.

2nd Annual Drug Safety MENA Summit, 13-14 February 2013, Abu Dhabi

The 2nd Annual Drug Safety Summit is due to take place in Abu Dhabi, UAE from 13-14 February 2013. Supported by the Centre Anti Poison et de Pharmacovigilance du Maroc, W.H.O. Collaborating Center fo...

EMA hosting pharmacovigilance meeting on Oct. 5

EMA will hold a EudraVigilance Information day on Oct. 5 to discuss the ongoing implementation of new pharmacovigilance legislation and adverse events reporting in the EU. The legislation took effect...

Training for New Pharmacovigilance Framework

Published date:  06/06/2012 Summary:  Training for New Pharmacovigilance Framework...

EMA finalises pharmacovigilance guidance

EMA announced on 25 June 2012 the release of the finalised versions of seven new guideline modules outlining good pharmacovigilance practices (GVPs) to assist sponsors with complying with the soon-to-...

Importance of cytochrome P450 (CYP450) in adverse drug reactions due to drug-drug interactions: a PharmacoVigilance study in France.

OBJECTIVE: Our aim was to characterize Adverse Drug Reactions (ADRs) related to drug-drug interactions (DDIs) related to involvement of cytochrome P450 (CYP450) isoenzymes in a pharmacovigilance datab...

Comparison of Adverse Drug Reactions with Donepezil versus Memantine: Analysis of the French Pharmacovigilance Database.

Background. Since donepezil and memantine are currently used for treating Alzheimer's disease, it is interesting to analyse, reassess and compare their safety profile in order to promote a better use....

Italian post-marketing surveillance for adverse event reports after MF59-adjuvanted H1N1v vaccination.

According to European recommendations, the Italian Medicines Agency (AIFA) required close monitoring of the safety of the MF59-adjuvanted H1N1v vaccine, which was the only vaccine available in Italy f...

Pharmacovigilance teaching in UK undergraduate pharmacy programmes.

PURPOSE: Pharmacists in the UK are able to report spontaneous adverse drug reactions (ADRs) to the Medicines and Healthcare Products Regulatory Authority. The level of reporting by UK pharmacists rema...

Pharmacovigilance and biosimilars: considerations, needs and challenges.

Introduction: Biosimilars are biologic medicines that are highly similar to approved biologics, notwithstanding minor differences in clinically inactive components. Since 2007, biosimilars have been a...