[e-farmacos] AINE y FDA

["Alvarinho, Fernando" <falvarin@mednet.org.uy>]

Algunas acciones en torno a la re-evaluacion del perfil de eficacia y seguridad de los AINE por parte de la FDA.

En el dia de hoy llega informacion de la FDA respecto a cambios que deben ser incluidos en los "labeling" de los AINE que se comercializan en USA (sea bajo receta o de venta libre).

Se solicita se incluya una advertencia destacada respecto al potencial aumento del riesgo de eventos cardiovasculares y de sangrados gastrointestinales que pueden poner en riesgo la vida.

La lista de farmacos incluye COX2 selectivos (celecoxib, valdecoxib, rofecoxib) y AINE no selectivos (Diclofenac, Diflunisal, Etodolac, Fenoprofen, Flurbiprofen, Ibuprofen, Indomethacin, Ketoprofen, Ketorolac, Mefenamic Acid, Meloxicam, Nabumetone, Naproxen, Oxaprozin, Piroxicam, Salsalate, Sulindac y Tolmetin).

La informacion esta disponible en:
http://www.fda.gov/cder/drug/infopage/COX2/default.htm

"COX-2 Selective (includes Bextra, Celebrex, and Vioxx) and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) 
Audience: Healthcare professionals and consumers
FDA has requested that sponsors of all non-steroidal anti-inflammatory drugs (NSAID) make labeling changes to their products. FDA recommended proposed labeling for both the prescription and over-the-counter (OTC) NSAIDs and a medication guide for the entire class of prescription products. All sponsors of marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, have been asked to revise the labeling (package insert) for their products to include a boxed warning, highlighting the potential for increased risk of cardiovascular (CV) events and the well described, serious, potential life-threatening gastrointestinal (GI) bleeding associated with their use. FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern."

Saludos,

Fernando Alvarino (con enie)
(Uruguay)




...quizas mas adelante se hable de la historia del iceberg que conocimos cuando "el error de los COX2" nos mostro la puntita ¿?... 
esperemos que no pase lo del titanic...