[e-farmacos] FDA: mas informacion sobre Vioxx

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

E-farmacos:  FDA: mas informacion sobre Vioxx
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El lunes 7 de mayo, la FDA publico nueva informacion que se incluira en
la ficha tecnica de VIOXX (rofecoxib) sobre contraindicaciones y
precauciones en pacientes con enfermedades cardiacas (cardiopatia
isquemica). Ver texto mas abajo. Esta es similar a la de Canada del
pasado 15 abril, para sanitarios
(http://www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/adviss_ind_e.html)
y para el Cosumidor
(http://www.hc-sc.gc.ca/english/protection/warnings/2002/2002_29e.htm)

Un cordial saludo,

Mariano Madurga
Agencia Espanhola del Medicamento
Espanha/Spain
mmadurga@agemed.es
http://www.agemed.es



The message below was received from the US Food and Drug Administration
on 7 May. The text of the FDA Talk Paper, referred to in this message,
is also copied below.


FDA and Merck strengthened the WARNINGS, PRECAUTIONS, and CLINICAL
STUDIES sections of Vioxx labeling to describe new cardiovascular and
gastroenterological safety information. This information reflected the
results of a prospective, active control study of Vioxx 50 mg daily
versus naproxen 500 mg twice daily and from a placebo-controlled trials
database.

This information should be taken into consideration and caution should
be exercised when Vioxx is used in patients with a medical history of
ischemic heart disease or hypertension.

Read the MedWatch 2002 Safety Information Summary, including links to
the FDA Talk Paper, "Dear Healthcare Professional" letter, and revised
package inserts, at:

http://www.fda.gov/medwatch/safety/2002/safety02.htm#vioxx 


FDA Talk Paper
FDA Approves New Indication and Label Changes for the Arthritis Drug,
Vioxx

FDA has approved a supplemental application for the use of Vioxx
(rofecoxib) for rheumatoid arthritis adding the indication to the
previously approved indications for osteoarthritis and pain. FDA has
also approved new label text and precautions that are based on the
results of the Vioxx Gastrointestinal Outcomes Research (VIGOR).

The VIGOR study, a prospective, randomized, double-blind, one year
study, evaluated approximately 4000 patients on Vioxx 50 mg a day (twice
the highest approved dose for chronic use) and approximately 4000
patients on the standard dose of naproxen (1000 mg a day), a
non-steroidal anti-inflammatory drug (NSAID). Patients who were under
treatment with low dose aspirin for heart attack prevention were
excluded from the study. 

The study demonstrated that Vioxx was associated with a lower incidence
of serious upper gastrointestinal(GI) adverse events of major bleeding,
perforation and obstruction compared to naproxen. The reduction in risk
was over 50 percent in cumulative rates for Vioxx (0.52%) compared to
naproxen (1.22%).

An additional finding in the study, however, was that there was a higher
cumulative rate of serious cardiovascular thromboembolic adverse events
(such as heart attacks, angina pectoris, and peripheral vascular events)
in the Vioxx group (1.8%) compared to the naproxen group (0.6%). Data
from two smaller studies comparing placebo and Vioxx 25 mg daily did not
show a difference in the rate of serious cardiovascular thromboembolic
adverse events. The relationship of the cardiovascular findings in the
VIGOR study to use of Vioxx is not known. 

After carefully reviewing the results of the VIGOR Study, FDA agreed
with the Arthritis Advisory Committee recommendations of February 8,
2001 that the label for Vioxx should include the gastrointestinal and
cardiovascular information. The committee advised that the NSAID-class
warning regarding GI adverse events should be modified, but not removed
from the VIOXX label. This warning advises patients and their doctors
about the risks of GI ulcers, bleeding, and perforation. 

The committee also advised that the CV findings should be included in
the Vioxx label to provide doctors and patients with the available data
on the potential risks and benefits of Vioxx compared to naproxen. The
new labeling information approved by FDA will advise doctors to use
caution in prescribing Vioxx for patients with ischemic heart disease
and notes that Vioxx 50 mg is not recommended for chronic use.

In addition, the new label provides information from studies of patients
with rheumatoid arthritis at the chronic dose of 25 mg, showing that
Vioxx was associated with a higher incidence of hypertension compared to
naproxen 1000 mg. 

In addition, the geriatric section of the label will reinforce
information in the existing standard warning  section of all NSAIDs
indicating that the elderly are at higher risk of serious GI and renal
events such as GI bleeding and acute renal failure. 


[NOTA: Mensaje sin acentos ni caracteres especiales.]
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