WHO Pharmaceuticals Newsletter 1998, No. 11&12
(1998; 10 pages)
Table des matières
Fermer ce répertoireRegulatory actions
Afficher le documentAcetylsalicylic acid and paracetamol: stricter controls: UK
Afficher le documentAlcohol warning: revised labelling of all OTC pain relievers & fever reducers: USA
Afficher le documentCamphor and/or menthol: warning concerning fire hazard: USA
Afficher le documentCholestin: determined to be an unapproved drug: USA
Afficher le documentCorticosteroids (inhaled and intranasal formulations): new labelling required for use in children: USA
Afficher le documentEphedrine and atropine: not accepted in final monographs for OTC internal analgesic or menstrual use: USA
Afficher le documentEritrityl tetranitrate: withdrawal of approval: lack of efficacy: USA
Afficher le documentL-desoxyephedrine (levmetamfetamine): added to monograph for OTC nasal decongestant drug products: USA
Afficher le documentMagnesium sulfate: revised labelling: UK
Afficher le documentNucleoside analogues: revised product information: hepatic steatosis and lactic acidosis: Portugal
Afficher le documentPovidone-iodine: warning concerning overdosage: Austria
Afficher le documentSoy protein and coronary heart disease: new health claim proposed: USA
Afficher le documentTick-borne encephalitis virus vaccine: paediatric formulation withdrawn: adverse reactions: Germany
Ouvrir ce répertoire et afficher son contenuDrug surveillance
Ouvrir ce répertoire et afficher son contenuNew developments
Ouvrir ce répertoire et afficher son contenuMedical devices
Ouvrir ce répertoire et afficher son contenuGeneral information
Ouvrir ce répertoire et afficher son contenuMedication errors
Ouvrir ce répertoire et afficher son contenuVeterinary medicine
 

Corticosteroids (inhaled and intranasal formulations): new labelling required for use in children: USA

United States of America. The Food and Drug Administration is requiring new paediatric information on the labelling of all orally inhaled and intranasal corticosteroids. The new labelling will alert health care providers that using these drugs in children may reduce their rate of growth. The labelling will also recommend using the lowest effective dose of these drugs and routinely monitoring patients’ growth rates. Inhaled corticosteroids are used to treat asthma. Intranasal corticosteroids are generally used to prevent and treat allergy-related nasal symptoms.

Patients are advised not to stop using their inhaled or intranasal corticosteroids without first consulting their health care providers about the benefits of these drugs compared to their risks. Manufacturers will continue to monitor these drugs to ascertain long-term effects.

Reference: FDA Talk Paper T98-79 dated 9 November 1998. [http://www.fda.gov/bbs/topics]

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Dernière mise à jour: le 3 mai 2013