Pharmacovigilance

EMA recommends modified-release paracetamol be removed from the market

Modified or prolonged-release paracetamol products should be removed from the market, the European Medicines Agency (EMA) has recommended.…

European Medicines Agency new adverse drug reactions system to go live in November

The European Medicines Agency has announced that its new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines, is on track to go live on 22 November 2017.…

Into the unknown: UK pharmacovigilance after Brexit

Julia Robinson reports from a meeting discussing the implications of Brexit on UK pharmacovigilance.…

Pharmaceutical industry urges European Council to decide new site for EMA

The pharmaceutical industry is urging the European Council to make a decision on the location of the new headquarters of the European Medicines Agency (EMA), preferably by June 2017, because of the potential “alarming” impact Brexit could have on medicines regulation.…

Drug classes commonly implicated in causing kidney injury identified

Researchers have identified the drug classes that are frequently implicated in causing acute kidney injury after analysing adverse drug reactions in a French national pharmacovigilance database.…

Patients lack knowledge on how to report adverse drug reactions

A lack of awareness about reporting systems for adverse drug reactions (ADRs) and confusion about how they work are preventing patients from informing medicines safety regulators when something goes wrong, according to research published in the British Journal of Clinical Pharmacology [1] …

Study suggests GLP-1 analogues do not raise breast cancer risk

Women with type 2 diabetes who take glucagon-like peptide-1 (GLP-1) analogues do not have a higher risk of breast cancer than those who take dipeptidyl peptidase-4 (DPP-4) inhibitors, results from a cohort study suggest.…

European medicines regulator sets out plans for revamped drug database

An electronic database containing information about all human medicines approved across Europe that will be accessible to the public as well as health professionals is being developed by the European Medicines Agency.…

Royal Pharmaceutical Society releases new pharmacovigilance guidance

The Royal Pharmaceutical Society (RPS) has launched new guidance on the EU-wide scheme for the additional monitoring of medicines, commonly known in the UK as the ‘black triangle’ scheme. In collaboration with the Association of the British Pharmaceutical Industry’s (ABPI) Ph…

Adverse drug reactions underreported in children aged under two years

Researchers have questioned the effectiveness of the MHRA’s Yellow Card scheme after receiving a low number of reports involving infants aged under two years.…