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Vioxx (Rofecoxib)l secret X FILES !!!
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Expedientes Secretos X del Vioxx (Rofecoxib) !!! Data-Médicos
EDITORIAL ESPAÑOL
Hola amigos de la red, HOY 30 DE SEPTIEMBRE DEL AÑO 2004, SE
CUMPLIÓ una vez mas
UNA DE LAS GRANDES VERDADES lanzadas POR EL DERMAGIC sobre LAS MOLÉCULAS COX-2.
EL GIGANTE MERCK decide voluntariamente retirar del mercado mundial a una de sus
MOLÉCULAS ESTRELLAS EL VIOXX O REFECOXIB. Saludos a todos Hello friends of the net, TODAY SEPTEMBER 30 OF THE YEAR 2004, it was COMPLETED
once ONE OF THE BIG TRUTHS rushed BY THE DERMAGIC on THE MOLECULES COX-2. THE
GIANT MERCK decides voluntarily to move away from the world market to one of its
BIG MOLECULES THE VIOXX OR REFECOXIB. Dr. José Lapenta R =================================================================
================================================================= ALMOST THREE YEARS LATER.... 1.) Merck Announces Voluntary Worldwide
Withdrawal of VIOXX® [email protected]
<[email protected]> WHITEHOUSE STATION, N.J., Sept. 30, 2004 - Merck &. Co., Inc. today announced a voluntary worldwide withdrawal of VIOXX® (rofecoxib), its arthritis
and acute pain medication. The company's decision, which is effective
immediately, is based on new, three-year data from a prospective, randomized, placebo- controlled clinical trial, the APPROVe (Adenomatous Polyp Prevention on VIOXX) trial. La multinacional Merck, que opera como MSD en Europa, retiró ayer del mercado su fármaco superventas Vioxx (rofecoxib), inhibidor selectivo de la COX-2, indicado para el tratamiento sintomático de la artritis reumatoide y de
la artrosis y comercializado como Ceoxx en España para el tratamiento sintomático
del dolor agudo a corto plazo, por su riesgo incrementado de accidente cardiovascular grave en tratamientos prolongados. Entonces, dice la Aemps, “aunque no pudo resolverse si este resultado se debía a un incremento de riesgo de rofecoxib o a un efecto protector de naproxeno, se procedió a modificar la información del medicamento dirigida a los profesionales y los pacientes para advertir de estos resultados”. Posteriormente, según la agencia, se han publicado varios estudios donde se observaba un incremento de riesgo pero solo a dosis superiores a 25 mg. La AEMPS insiste en que “los datos se refieren únicamente a rofecoxib y que no pueden generalizarse a otros inhibidores selectivos de la COX-2”. Y aconseja que aunque los riesgos detectados sólo ocurren tras un tratamiento prolongado (más de 1 año) con Vioxx, se recomienda la suspensión del mismo puesto que es fácilmente sustituible por tratamientos alternativos sobre los cuales el médico de familia podrá determinar la alternativa más adecuada a las necesidades de los pacientes. Vioxx facturó en 2003 2.300 millones de euros en el mundo y desde enero de 2004, 20 millones de euros en España. En los últimos doce meses se han tratado en España 277.000 pacientes con el fármaco, aunque no necesariamente en uso crónico. Actualmente Sanidad estima que podría haber entre 70.000 y 100.000 pacientes en tratamiento con este fármaco, que requiere como otros coxibs visado
de inspección desde julio de 2002 en España. Vioxx, sin embargo, no está cubierto por la seguridad social. Nueva York, EE.UU.(RCN) - La farmacéutica Merck hizo este anuncio tras los resultados de un estudio que confirmó un mayor riesgo de problemas cardíacos y de otro tipo en los pacientes que reciben este tratamiento. Ante la divulgación de la noticia, las acciones de la empresa cayeron casi el 27 por ciento en el mercado de Nueva York, donde media hora después de comenzar la sesión se cotizaban en torno a los 33 dólares. En un comunicado entregado a los medios de comunicación, la empresa indicó que el estudio, llevado a cabo durante tres años, reveló un mayor riesgo de sufrir problemas cardiovasculares, como "un ataque cardíaco o un derrame cerebral", después de 18 meses de tratamiento en los pacientes que tomaron Vioxx que en los que tomaron placebos. 4.) Merck halts Vioxx sales.
By Rita Rubin, USA TODAY The maker of blockbuster pain reliever Vioxx said Thursday that it is voluntarily withdrawing the drug because of new data showing it increases the risk of heart attacks and strokes.By Mike Derer, AP This is one of the largest-ever withdrawals of a drug, says the Food and Drug Administration's Steven Galson. Drugmaker Merck (MRK) says 84 million people worldwide have taken the heavily promoted drug, available in the USA since May 1999. About 2 million Americans are on Vioxx, Galson says. "We have been concerned and aware of the potential for cardiovascular effects for the last few years," he says. "This is not a total surprise. "The news hit Merck's stock hard. It fell 27% to close at $33, wiping out $27 billion in market value.In August, an FDA-funded analysis involving Kaiser Permanente patients found more heart attacks and sudden cardiac deaths among people taking Vioxx than among those on Celebrex or on conventional nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and aspirin. In November 2000, Merck published a study in The New England Journal of Medicine that found a higher rate of heart attacks in patients assigned to Vioxx than those assigned to naproxen (an NSAID sold as Aleve). Because of that finding, the FDA in April 2002 required a new warning on the Vioxx label.Vioxx, Celebrex and Bextra are the three so-called COX-2 inhibitors on the U.S. market. Drugmakers say they treat arthritis pain but are less irritating to the gastrointestinal tract than traditional NSAIDs. At least two other COX-2 inhibitors — including Merck's Arcoxia, already sold in 47 other countries — are in the pipeline."It is important to note that the results of clinical studies with one drug in a given class are not necessarily applicable to others in a class," says Peter Kim, president of Merck Research Laboratories. The implications of the Vioxx withdrawal for other COX-2 inhibitors aren't yet clear. Merck says the new data — from a three-year study comparing Vioxx with a placebo in 2,600 patients with colon polyps — showed a higher risk of heart attacks and stroke only after 18 months of use. None of the other COX-2 drugs have data for longer than a year, Galson says."It's too early for me to say right now how we're going to change our requirements for the future, but, obviously, we're going to be more interested in long-term data," he says.
Merck Pulls Vioxx Arthritis Drug From Market
on Heart Attack, Stroke TRENTON, N.J. Sept. 30, 2004 — Merck & Co. is pulling its blockbuster Vioxx
from the market after new data found the arthritis drug doubled the risk of
heart
attacks and strokes. Merck's stock plunged almost 27 percent as the pharmaceutical giant said the recall will hurt its earnings. Merck said Thursday the clinical trial data showed an increased risk of heart
attack and other cardiovascular complications 18 months after patients started taking
Vioxx, which also is prescribed for acute pain and disorders such as carpal
tunnel syndrome. The three-year study aimed at showing that Vioxx could prevent the recurrence of
polyps, which can turn cancerous, in the colon and rectum was stopped after Merck discovered participants had double the risk of a heart attack compared to
those taking a placebo.By Thursday afternoon, at least one plaintiffs' attorney announced plans for a
class -action lawsuit against Merck. Another claimed to represent 58 patients around
the country allegedly harmed by Vioxx, including people who suffered a heart attack,
stroke, internal bleeding or kidney failure."It's a disaster for Merck, coming at the worst time," said independent health
care analyst Hemant Shah of HKS & Co. in Warren, N.J.About 2 million people worldwide use Vioxx, Merck said, and 84 million have taken it since it came on the market with great fanfare in 1999. It is one of
Merck's most important drugs, with $1.8 billion in U.S. sales in 2003 and global sales
of $2 .5 billion 11 percent of the company's $22.49 billion in revenue that year.But Vioxx sales dipped 18 percent in the second quarter of this year to $653 million, partly due to increasing concerns about an elevated risk of heart complications.Medical experts advised patients Thursday to stop taking Vioxx and consult their
Ray V. Gilmartin, Merck's chairman, president and chief executive, said in a statement.Shares in Merck, the world's third-biggest drug maker, plunged $12.07, nearly 27
percent, to close at $33.00 on the New York Stock Exchange. That wiped out $ 28 billion in market value. More than 140 million shares were traded, compared
to a daily average below 10 million.Shah said for Merck, the Vioxx withdrawal comes "at a time when they really need
to get ready for expiration" of its patent for Zocor, the cholesterol treatment
that is the company's top-selling drug.Zocor loses patent protection early in 2006 and sales are expected to plunge against generic competition. In an effort to replace those revenues, Merck recently launched a drug with Schering-Plough Corp., Vytorin, that combines Zocor and Schering-Plough's Zetia to attack cholesterol levels in two complementary ways.The Vioxx recall stands to benefit Pfizer Inc., the world's biggest drugmaker.
Merck and Pfizer have been battling for market share, with Pfizer's Celebrex arthritis drug dominating the market with about $5 billion in U.S. sales alone
last year. Pfizer shares were up 35 cents to $30.53 in afternoon trading on the NYSE.Pfizer issued a statement Thursday citing the "outstanding long-term safety
profile" of Celebrex and saying that in a recent FDA-sponsored study of 1.4 million patients, those who received Celebrex demonstrated no increased risk of cardiac
trouble.Vioxx was labeled with a warning about heart risks in 2001 after Merck's own study in 2000 uncovered the increased risk of heart attack and other
complications. The Food and Drug Administration has been monitoring problems reported to it since then."This is not a total surprise," said Dr. Steven Galson, acting director of the
FDA's Center for Drug Evaluation and Research.Dr. Steven Abramson, director of rheumatology at New York University Hospital
for Joint Diseases, said "there are very few patients for whom there won't be a
good alternative drug." particularly on the gastrointestinal system, than
older drugs.Vioxx's removal will be a blow to hopes that it and other drugs in the class
known as COX-2 inhibitors could be used to prevent cancer in people at high risk of
developing it. A landmark study in 2002 showed that small, daily doses of
aspirin could prevent colon cancer, and studies hinted that COX-2 inhibitors might do
the same possibly without aspirin's side effects.All COX-2 inhibitors can raise blood pressure, but Vioxx appears to be the only
one that's been linked to higher risk of heart attacks and strokes, Galson said.Merck is scheduled to release financial results for the third quarter, which
ends today, on Oct. 21. Cornea. 2004 Oct;23(7):736-737. *Department of Ophthalmology, The Georgetown University-Washington Hospital CONCLUSION: This case report suggests that oral rofecoxib may trigger Stevens-Johnson syndrome, potentially causing symblepharons, corneal neovascularization and cicatricial ectropions. [email protected]
<[email protected]> NEW YORK, September 30, 2004 -- In response to Merck & Co.'s |
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Produced by Dr. José Lapenta R. Dermatologist
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