WHO Pharmaceuticals Newsletter 2003, No. 04
(2003; 13 pages) Ver el documento en el formato PDF
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Cerrar esta carpetaREGULATORY MATTERS
Ver el documentoABACAVIR, LAMIVUDINE, TENOFOVIR - Virologic non-response in HIV with combination therapy
Ver el documentoACETYL-SALICYLIC ACID (PAEDIATRIC) - OTC withdrawal
Ver el documentoACETYL-SALICYLIC ACID, PARACETAMOL, IRON - New packaging standards for improving child resistance
Ver el documentoBENZ-BROMARONE - Withdrawn due to reports of liver damage
Ver el documentoEZETIMIBE - Labelling update regarding hypersensitivity reactions
Ver el documentoLEFLUNOMIDE - Explicit liver function monitoring directions added to label
Ver el documentoPAROXETINE - Unfavourable risk benefit ratio in children and adolescents
Ver el documentoSALMETEROL - Risk of life-threatening asthma episodes
Ver el documentoSOMATROPIN (rDNA ORIGIN) - Reports of fatalities in paediatric patients with Prader-Willi syndrome
Ver el documentoTIROFIBAN - Advice against off-label use
Ver el documentoTOPIRAMATE - Risk of oligohidrosis and hyperthermia
Abrir esta carpeta y ver su contenidoSAFETY OF MEDICINES
Abrir esta carpeta y ver su contenidoDRUGS IN THE NEWS
 

SALMETEROL - Risk of life-threatening asthma episodes

USA. The US FDA is advising that all drug products containing salmeterol will now include new safety information and warnings about a small but significant number of reports of life-threatening asthma episodes or asthma related deaths in patients taking these products. Salmeterol is a long-acting bronchodilator used to treat asthma and chronic obstructive pulmonary disease (COPD). The FDA announcement follows the findings of a large safety study in the US showing a significant increase in respiratory-related death or life-threatening experience in African-American patients treated with the drug (Serevent). However, the FDA emphasizes that based on available data, the benefits of treatment with salmeterol in patients with asthma and COPD continue to outweigh the potential risks when used according to the instructions contained in the product labelling. Patients should not stop taking products that contain salmeterol, or any other medication for asthma or COPD without consulting their physicians since abrupt discontinuation of therapy can result in worsening of the disease with serious and fatal consequences.

Reference:

FDA Talk Paper, 14 Aug 2003. Available from URL: http://www.fda.gov

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