What are the Alternatives to Vioxx?

Written by Michael Monheit, Esquire, Monheit Law, PC

Withrepparttar withdrawal of Vioxx fromrepparttar 119248 pharmaceutical market, doctors and patients are left scrambling for alternatives to Vioxx.


The below is only informational, and is not offered as medical advice! Only your doctor can determine what pain killers will be right for you.

Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved byrepparttar 119249 FDA in May 1999 forrepparttar 119250 relief of osteoarthritis, for menstrual symptoms, andrepparttar 119251 management of acute pain in adults. Pain relievers called NSAIDs, work against two enzymes -- COX-1 and COX-2 -- that frequently cause inflammation and pain. Cox-1 is found inrepparttar 119252 stomach and Vioxx and its alternatives that attack it often cause upset stomachs and ulcers. Vioxx and Vioxx alternatives are known as a class of drugs called COX-2 inhibitors attack that sole enzyme, minimizing stomach side effects.

Are other alternatives to Vioxx safe? COX-2 drugs haverepparttar 119253 tendency to raise blood pressure, but only Vioxx has been linked to a higher risk of heart attack, stroke, and other cardiovascular problems. Although there is now study showing that some alternatives to Vioxx also cause heart problems. For example,repparttar 119254 study released in October 2004 regarding Bextra and heart surgery patients.

Two COX-2 inhibitor alternatives to Vioxx are sold inrepparttar 119255 U.S. – Celebrex and Bextra. However,repparttar 119256 safety has of these altnernatives to Vioxx been questioned. Drug manufacturers – Pharmacia and Pfizer have huge advertising budgets and sales inrepparttar 119257 millions.

Why am I mad at Merck over Vioxx?

Written by Michael Monheit, Esquire, Monheit Law, PC

What is disturbing to me, is that given years of evidence that there was a risk of stroke and heart attack from Vioxx, Merck did NOT set out to studyrepparttar cardiac impact -- rather only when it had an opportunity to add a new market forrepparttar 119247 drug did they do a study which accidentally caused Merck to acknowledge publicly what it already knew privately. This study, and only by "accident" turned out to thte public whatrepparttar 119248 public should have known and Merck already did know sooner... In May 1999repparttar 119249 Food and Drug Administration (FDA) approved Vioxx. The original safety database included approximately 5,000 patients on Vioxx and did not show an increased risk of heart attack, stroke, blood clots, or sudden death. One year later in June 2000, Merck submitted a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) torepparttar 119250 FDA that found an increased risk of Vioxx heart attacks and strokes in patients taking Vioxx compared to patients taking naproxen. After reviewingrepparttar 119251 VIGOR study results and other available data from controlled clinical trials,repparttar 119252 FDA consulted with its Arthritis Advisory Committee in February 2001 regardingrepparttar 119253 clinical interpretation of this new questionable Vioxx-related information. Perhaps, back in Feb of 2001, it was "questionable," butrepparttar 119254 "question" aboutrepparttar 119255 lack of safety for Vioxx was squarely put forth to Merck, and Merck had a moral obligation, not to mention and financial obligation to its shareholders, to look further into this -- THEN. They did not.

Why not? -------- Why did it take 22 months (June 2000 to Feb 2001) to alertrepparttar 119256 medical community and its patients about life threatening risks for Vioxx induced chest pain, heart attacks, blood clots, stroke, and sudden death?

... I would argue, and yes, this is me with my attorney hat on and you arerepparttar 119257 jury, that there were $2.5 Billion reasons each year that they did not look further atrepparttar 119258 heart attack issue for years. On September 17, 2001 (and, to Merck’s good fortune, lost inrepparttar 119259 news ofrepparttar 119260 terrorist attacks of 9/11),repparttar 119261 FDA issued an 8-page warning letter to Merck concerning its false and misleading promotional campaign. The FDA found: “You have engaged in a promotional campaign that minimizesrepparttar 119262 potentially serious cardiovascular findings that were observed inrepparttar 119263 VIOXX Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresentsrepparttar 119264 safety profile for VIOXX. Specifically, your promotional campaign discountsrepparttar 119265 fact thatrepparttar 119266 VIGOR study patients on VIOXX were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients onrepparttar 119267 comparator nonsteroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen).”

So. finally, in April 2002, after "foot dragging" (you'd call it due diligence or appropriate caution) an FDA that is stacked with folks coming in and out ofrepparttar 119268 Pharma industry, in release T02-18 (4/11/2002) required Merck to labelrepparttar 119269 drug as a cardiac risk.

"FDA has approved a supplemental application forrepparttar 119270 use of Vioxx (rofecoxib) for rheumatoid arthritis addingrepparttar 119271 indication torepparttar 119272 previously approved indications for osteoarthritis and pain. FDA has also approved new label text and precautions that are based onrepparttar 119273 results ofrepparttar 119274 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 (twicerepparttar 119275 highest approved dose for chronic use) and approximately 4000 patients onrepparttar 119276 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 fromrepparttar 119277 study.... An additional finding inrepparttar 119278 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) inrepparttar 119279 Vioxx group (1.8%) compared torepparttar 119280 naproxen group (0.6%). Data from two smaller studies comparing placebo and Vioxx 25 mg daily did not show a difference inrepparttar 119281 rate of serious cardiovascular thromboembolic adverse events. The relationship ofrepparttar 119282 cardiovascular findings inrepparttar 119283 VIGOR study to use of Vioxx is not known. After carefully reviewingrepparttar 119284 results ofrepparttar 119285 VIGOR Study, FDA agreed withrepparttar 119286 Arthritis Advisory Committee recommendations of February 8, 2001 thatrepparttar 119287 label for Vioxx should includerepparttar 119288 gastrointestinal and cardiovascular information. The committee advised thatrepparttar 119289 NSAID-class warning regarding GI adverse events should be modified, but not removed fromrepparttar 119290 VIOXX label. This warning advises patients and their doctors aboutrepparttar 119291 risks of GI ulcers, bleeding, and perforation. " That is an increase over over 1 in 100 people who takerepparttar 119292 drug having a heart attack because of it. Pretty statistically significant. It means that we both probably know someone who this happened to. OK, now fast forward torepparttar 119293 more recent study. Only when they saw gold in their pockets, selling Vioxx intorepparttar 119294 cancer prevention market, did Merck dorepparttar 119295 study. Only this timerepparttar 119296 study turned out to confirm what they already "suspected" in June 2000, but failed to actually study it. Atrepparttar 119297 very least, they should have done further study three years ago forrepparttar 119298 specific problem that they subsequently confirmed inrepparttar 119299 more recent study. This attitude simply ignoredrepparttar 119300 mounting evidence that VIOXX was, indeed,repparttar 119301 killer it had always been suspected of being. This is allrepparttar 119302 more obvious when one considersrepparttar 119303 following facts:

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