[e-farmacos] FDA: cambios en julio 2005 por razones de seguridad

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

Estimadas y estimados,

Los cambios que la FDA ha introducido en los medicamentos por motivos de seguridad (farmacovigilancia) durante el mes de julio de 2005 estan disponibles en la direccion de la FDA-Medwatch, segun este mensaje:

Safety-related drug labeling changes for July 2005 have been posted on the MedWatch website. The July 2005 posting includes 32 drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS sections.

The Summary page -- http://www.fda.gov/medwatch/SAFETY/2005/jul05_quickview.htm  
-- provides drug names and a listing of the sections changed. 

The Detailed view -- http://www.fda.gov/medwatch/SAFETY/2005/jul05.htm  
-- includes sections/subsections changed and a description of new or modified safety information in the Contraindications, Boxed Warning, or Warnings sections. The full labeling may be accessed by clicking on the drug name in the detailed view.

The following drugs had modifications to the CONTRAINDICATIONS and/or WARNINGS/BOXED WARNINGS sections: 

Arthritic (diclofenac sodium/misoprostol) Tablets 
Celebrex (celecoxib capsules) 
NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) 
Pipracil (piperacillin sodium) 
Pravachol (pravastatin sodium) Tablets 
Mifeprex (mifepristone) Tablets 
Enbrel (etanercept) For Subcutaneous Injection 
Flovent Diskus (fluticasone propionate inhalation powder) 
Neoral  Soft Gelatin Capsules (cyclosporine capsules, USP) Modified 
Neoral  Oral Solution (cyclosporine oral solution, USP) Modified 
Norplant System (levonorgestrel implants) 
Reytaz (atazanavir sulfate) Capsules 
Sandimmune Soft Gelatin Capsules (cyclosporine capsules, USP) 
Sandimmune Oral Solution (cyclosporine oral solution, USP) 
Sandimmune  Injection (cyclosporine injection, USP) FOR INFUSION ONLY 

Un abrazo,

Mariano Madurga
Agencia Espanhola de Medicamentso y PS
mmadurga@agemed.es
www.agemed.es