[AF] becaplermina y cáncer

Pedro del Río Pérez pedrodelrio en ono.com
Jue Abr 24 19:50:43 CEST 2008

La becaplermina es un medicamento comercializado en España
con el nombre "Regranex 100 MG/G  15 GRAMOS GEL".
Su ficha técnica está disponible en:
Se trata de Factor de Crecimiento Plaquetario BB humano
recombinante (rhPDGF-BB). Está indicado en la cicatrización
de las úlceras diabéticas.

En Medscape tenemos esta información:
"Gel para el tratamiento de úlceras diabéticas relacionado con
incremento de muertes por cáncer"
Para poder acceder hay que registrase (gratis). Como la nota es
breve, copio y pego seguidamente:

Diabetic Ulcer Gel Linked to Increased Cancer Deaths.

A safety review of becaplermin gel (Regranex, Johnson & Johnson) is
being conducted after study results suggested an increased risk for
cancer-related mortality, the US Food and Drug Administration (FDA)
warned healthcare professionals yesterday.
In the study, a health insurance database was used to identify 2
groups of diabetic patients aged 19 years and older with similar
diagnoses, drug use, and use of health services from January 1998
through June 2003. One group had been prescribed becaplermin gel,
and the other had not.
Analysis revealed an overall increase in the number of cancer deaths
among patients who had been prescribed the gel 3 or more times for
diabetic foot and leg ulcers. Insufficient information was available to
determine whether there was an increase in the incidence of new
cancers, the FDA said.
The findings supported those of a long-term study completed by the
manufacturer in 2001, which also showed more cancers in patients
using becaplermin compared with those who did not.
While the review is ongoing, the FDA recommends that healthcare
professionals discuss the potential risks and benefits of becaplermin
gel with their patients, according to an alert issued by MedWatch,
the FDA's safety information and adverse event reporting program.
Becaplermin 0.01% gel is a recombinant form of human platelet-derived
growth factor that is indicated for the treatment of lower extremity
diabetic neuropathic ulcers with an adequate blood supply that extend
into the subcutaneous tissue or beyond.

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