WHO Pharmaceuticals Newsletter 1999, No. 01&02
(1999; 16 pages)
Índice de contenido
Cerrar esta carpetaRegulatory actions
Ver el documentoAlbumin (human): batches withdrawn: increase in aluminium level: Germany
Ver el documentoAlfalfa products: caution label: Malaysia
Ver el documentoAmineptine: marketing authorization suspended: drug abuse and dependence: France
Ver el documentoAstemizole: OTC formulations withdrawn: UK
Ver el documentoCisapride: restricted indications: Ireland
Ver el documentoDronabinol: proposed reclassificaion from Schedule II to Schedule III of the US Controlled Substances Act: USA
Ver el documentoEntacapone: revised product information: caution concerning use: EMEA
Ver el documentoFurazolidone: withdrawn: Yemen
Ver el documentoGinkgo biloba parenteral infusion formulation: suspension further extended: Germany
Ver el documentoIsotretinoin: revised prescribing information: depression: Ireland
Ver el documentoKaolin and pectin suspension: withdrawn: Yemen
Ver el documentoLevocarnitine: revised data sheet: seizures: USA
Ver el documentoLoratadine/pseudoephedrine sulfate: reformulated: UK
Ver el documentoMetamizole sodium: withdrawn due to agranulocytosis: Yemen
Ver el documentoMethadone mixture: child-resistant packaging recommended: Germany
Ver el documentoMethylrosanilinium chloride (Gentian violet): withdrawn: Malaysia
Ver el documentoMontelukast: revised data sheet: eosinophilia: UK
Abrir esta carpeta y ver su contenidoDrug surveillance
Abrir esta carpeta y ver su contenidoNew developments
Abrir esta carpeta y ver su contenidoGeneral information
Abrir esta carpeta y ver su contenidoMedication errors
Abrir esta carpeta y ver su contenidoVeterinary medicine
 

Levocarnitine: revised data sheet: seizures: USA

United States of America. The manufacturer of levocarnitine (Carnitor: Sigma-Tau) has revised the adverse reaction section of the labelling for the tablet, oral solution and injection formulations to include the following statement regarding the occurrence of seizures in some patients receiving levocarnitine:

“Seizures have been reported to occur in patients with or without pre-existing seizure activity receiving either oral or intravenous levocarnitine. In patients with pre-existing seizure activity, an increase in seizure frequency and/or severity has been reported.”

Reference: “Dear Health Professional” letter from Sigma-Tau Inc., 23 July 1998.
[http://www.fda.gov/medwatch/safety/1998/carnit.htm]

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Última actualización: le 3 mayo 2013