During its November 2023 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that the available evidence does not support a causal association between the glucagon-like peptide-1 (GLP-1) receptor agonists - exenatide, liraglutide, dulaglutide, semaglutide, and lixisenatide - and thyroid cancer.
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PRAC January 2023 - recommendations for Janus kinase (JAK) inhibitors and information about Zolgensma
Alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors and New safety information for healthcare professionals for Zolgensma
Flash VIG-news: Pregabalin (Lyrica and generics): risks of misuse, abuse, and dependence
For several years, health authorities in European countries have noted a worrying increase in pregabalin abuse. Here are some reminders of the risks of misuse, abuse, and addiction with pregabalin.
MedSafetyWeek 2022: annual campaign to promote adverse reactions reporting
The global MedSafetyWeek runs from 7 to 13 November 2022. During this annual social media campaign, the FAMHP is also encouraging everyone to report suspected adverse reactions to medicinal products.
Flash VIG-news : Dispensation of pholcodine-containing medicinal products suspended due to the risk of allergic cross-reactivity with neuromuscular blocking agents
Due to concerns about the risk of anaphylactic reactions, the dispensation of pholcodine-containing medicinal products is suspended from 1 October 2022.
PRAC September 2022 –Reviews of topiramate and pholcodine medicines started
During the September 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral of topiramate and also started a referral of pholcodine medicines.
PRAC July 2022 – New measures for medicinal products containing nomegestrol or chlormadinone and start of assessment of neurodevelopmental disorders when using topiramate
During its July 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends new measures to minimise the risk of meningioma with medicines containing nomegestrol or chlormadinone. The PRAC also starts the review on the risk of neurodevelopmental disorders with topiramate.
Update on the safety notifications about CPAP, BiPAP and ventilator devices manufactured by Philips
Extensive analyses of Philips' CPAP, BiPAP and ventilator devices have not revealed toxicologically relevant levels of volatile organic compounds. Nevertheless, no risk can be excluded at this time: patients are advised to consult their physician about the further course of their treatment.
PRAC May 2022 – Discussion regarding a direct healthcare professional communication (DHPC) containing important information for Defitelio
During its April 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) discussed a direct healthcare professional communication (DHPC) containing important information for Defitelio.
PRAC April 2022 – No causal association found between the COVID-19 vaccines Comirnaty and Spikevax and autoimmune hepatitis
During its April 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that available evidence does not support a causal link between COVID-19 vaccines Comirnaty and Spikevax and very rare cases of autoimmune hepatitis.