[e-farmacos] FDA: avisa de pronta resolucion sobre glitazonas

["Madurga, Mariano" <mmadurga@agemed.es>]

Estimadas y estimados colisteros,

La FDA acaba de informar de la proxima reunion conjunta del panel de expertos y de su Comite de Seguridad y Gestion de Riesgos, que el proximo 30 de julio revisara el balabnce beneficio-riego de las glitazonas, pioglitazona y rosiglitazona.

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The FDA has released documents on the cardiac risks of rosiglitazone (Avandia®) ahead of its advisory panel meeting on July 30 to discuss the thiazolidinedione class of antidiabetic drugs. A summary from FDA staff said "various datasets present an array of somewhat inconsistent findings that complicate the interpretation of the available data." 

The panel will be asked if rosiglitazone increases MI risk, and if so, whether the dangers are greater than with other diabetes drugs. If the advisers decide that the drug should still be sold, the FDA will ask about other steps, such as adding a strong "black box" warning or limiting use to certain patients. The FDA usually follows panel recommendations. Glaxo said that a new company-funded study of health insurance records of more than 400,000 diabetics found rosiglitazone was not linked with a higher MI risk compared with other oral diabetes drugs. Briefings from the FDA and Glaxo can be found on the FDA website at the above links.
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La pagina web con el informe de la FDA de 436 paginas en: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4308b1-02-fda-backgrounder.pdf
 
Un abrazo,

Mariano Madurga Sanz
Agencia Espanhola de Medicamentos y Productos Sanitarios
www.agemed.es <http://www.agemed.es>  
mmadurga@agemed.es <mailto:mmadurga@agemed.es>