WHO Pharmaceuticals Newsletter 2005, No. 01
(2005; 12 pages) Voir le document au format PDF
Table des matières
Fermer ce répertoireREGULATORY MATTERS
Afficher le documentAMIODARONE - Medication Guide to be dispensed along with medicine
Afficher le documentATOMOXETINE - Labelling to include liver injury warning
Afficher le documentBENZATHINE BENZYL-PENICILLIN/PROCAINEBENZYLPENICILLIN - Label changes highlight appropriate use
Afficher le documentMEFLOQUINE - Patient Information Leaflet to help recognize adverse symptoms
Afficher le documentPARACETAMOL-DEXTROPROP-OXYPHENE - To be withdrawn due to risk of toxicity in overdose
Afficher le documentSMALLPOX VACCINE - Label to highlight reports of myopericarditis
Afficher le documentTHIORIDAZINE - Withdrawn due to poor benefit/risk profile
Ouvrir ce répertoire et afficher son contenuSAFETY OF MEDICINES
Ouvrir ce répertoire et afficher son contenuDRUGS OF CURRENT INTEREST
Ouvrir ce répertoire et afficher son contenuFEATURE

ATOMOXETINE - Labelling to include liver injury warning

USA. The US FDA has issued a Talk Paper advising of changes to the US atomoxetine (Strattera) labelling, following two reports of severe liver injury in patients who had received the agent for several months. Atomoxetine is a selective norepinephrine reuptake inhibitor indicated in the treatment of attention deficit hyperactive disorder (ADHD) in children, adolescents and adults. The atomoxetine labelling is to be updated to include a bolded warning regarding the risk of severe liver injury that could progress to liver failure, requiring liver transplantation or resulting in death, although it is noted that the actual number of cases is unknown. The new warning advises discontinuation of atomoxetine if patients develop jaundice or laboratory evidence of liver injury. Eli Lilly has agreed to issue a 'Dear Healthcare Professional' letter regarding these changes, and will update the atomoxetine patient package insert to include information about the signs and symptoms of liver disorders.


FDA Talk Paper, 17 December 2004. Available on the Internet at www.fda.gov

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