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Posted: 9/30/2004 2:27:57 PM EST
Sorry if this is a dupe.

FOR IMMEDIATE RELEASE
P04-95
September 30, 2004
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA



FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product
The Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck & Co. FDA today also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.

Merck is withdrawing Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo. The study was being done in patients at risk of developing recurrent colon polyps.

"Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," said Acting FDA Commissioner Dr. Lester M. Crawford. "Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo."

Dr. Crawford added that FDA will closely monitor other drugs in this class for similar side effects. "All of the NSAID drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician."

FDA approved Vioxx in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain. It was the second of a new kind of NSAID (Cox-2 selective) approved by FDA. Subsequently, FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children.

At the time that Vioxx and other Cox-2 selective NSAIDs were approved, it was hoped that they would have a lower risk of gastrointestinal ulcers and bleeding than other NSAIDs (such as ibuprofen and naproxen). Vioxx is the only NSAID demonstrated to have a lower rate of these side effects.

Merck contacted FDA on September 27, 2004, to request a meeting and to advise the agency that the long-term study of Vioxx in patients at increased risk of colon polyps had been halted. Merck and FDA officials met the next day, September 28, and during that meeting the company informed FDA of its decision to remove Vioxx from the market voluntarily.

In June 2000, Merck submitted to FDA a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) that found an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking Vioxx compared to patients taking naproxen. After reviewing the results of the VIGOR study and other available data from controlled clinical trials, FDA consulted with its Arthritis Advisory Committee in February 2001 regarding the clinical interpretation of this new safety information. In April 2002, FDA implemented labeling changes to reflect the findings from the VIGOR study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke.

Recently other studies in patients taking Vioxx have also suggested an increased risk of cardiovascular events. FDA was in the process of carefully reviewing these results, to determine whether further labeling changes were warranted, when Merck informed the agency of the results of the new trial and its decision to withdraw Vioxx from the market.

Additional information about this withdrawal of Vioxx, as well as questions and answers for patients, is available online at http://www.fda.gov/cder/drug/infopage/vioxx/default.htm.


FDA Public Health Advisory
Questions and Answers
Merck & Co. Press Release

Link Posted: 9/30/2004 2:31:17 PM EST
Link Posted: 9/30/2004 2:34:56 PM EST

Originally Posted By Aimless:
RELEASE THE LAWYERS!!



Unfortunately, I believe the class action lawsuit is in the works already. Be sure to see people who might have tried it for 2 weeks claim they deserve money.
Link Posted: 9/30/2004 2:36:43 PM EST
Link Posted: 9/30/2004 2:37:57 PM EST
ok i'm clueless wtf is vioxx used for?



Link Posted: 9/30/2004 2:38:42 PM EST
[Last Edit: 9/30/2004 2:40:03 PM EST by DK-Prof]

Originally Posted By Dino:
ok i'm clueless wtf is vioxx used for?






Arthritis, primarily



... I was prescribed Vioxx, but luckily I was too cheap to pay $50 a month (or something crazy like that) so I just take Alleve when my knee bothers me.

Yeah for me - my cheapness may have saved my life
Link Posted: 9/30/2004 2:39:17 PM EST
Link Posted: 9/30/2004 2:40:45 PM EST
i took it for a month .now i have chest pains. i need a lawyer

meat
Link Posted: 9/30/2004 2:52:51 PM EST
Celebrex is another Cox-2 inhibitor, so I'd stop taking it just in case.
Link Posted: 9/30/2004 2:58:41 PM EST

Originally Posted By Misery:
Celebrex is another Cox-2 inhibitor, so I'd stop taking it just in case.



My rheumatologist called me this am. Took me off Vioxx and put me on Celebrex.
Link Posted: 9/30/2004 3:19:35 PM EST
I took a 30mg tab of Vioxx last week, first time ever, for a gout attack. It knocked the hellout of it real well. Too bad it has lousy side effects.

So, how much money will i get from the class action suit? Enough for a .50?
Link Posted: 9/30/2004 3:21:20 PM EST

Originally Posted By rainman:


So, how much money will i get from the class action suit? Enough for a .50?




No, but your lawyer will.
Link Posted: 9/30/2004 3:26:06 PM EST
I took it after having wisdom teeth out. For pain relief, the stuff worked almost as well as Vicodin, and didn't send me to the moon. I didn't notice side effects, but I was a little preoccupied Overall I was _very_ impressed.

Damn shame the stuff didn't work out. Now I guess they'll need to see if this is a common issue among NSAID's, or just something confined to the one drug. The blood is in the water one way or the other.
Link Posted: 9/30/2004 3:27:55 PM EST


found an increased risk of serious cardiovascular events, including heart attacks and strokes in patients taking Vioxx compared to patients taking naproxen





Gotta wonder about this line.

Maybe Naproxen is a better platelet inhibitor than Vioxx, and it is naturally reducing the incidence of CVA, TIA and MI due to thromboses rather than Vioxx actually increasing the incidence.

They should probably do a study with Naproxen, Vioxx, and a Sugar Pill to see what the differences are. If it is a study with patients at risk for reoccuring colon polyps, it is likely an older patient population.

Just a thought.

AFARR
Link Posted: 9/30/2004 5:57:17 PM EST
Pfizer must be very happy to gain that much market share.
Link Posted: 9/30/2004 6:11:22 PM EST
I wonder if this means that CELEBREX is going to be pulled later on too since they appear to be roughly the same .

Both of them go after the Cox-2 enzyme and are known as Rofecoxib. Sure makes me wonder. I've been using CELEBREX for about three years. Before that it was Naproxen .
Link Posted: 9/30/2004 6:55:05 PM EST
That sucks. It's an excellent drug which I have taken a few times and it usually fixes the inflamation immeditely.

GunLvr
Link Posted: 9/30/2004 6:59:07 PM EST
Betxtra is much closer to Vioxx than Celebrex. Celebrex tends to be less effective as an anti-inflammatory for most people.
Link Posted: 9/30/2004 7:01:35 PM EST
Every night for me boys. Twenty five big honkin,' pain numbing, milligrams. Might do it tonight, too. Good night.
Link Posted: 9/30/2004 7:35:55 PM EST
Vioxx tore my stomach up.
I'll just stick with vitamin M (Motrin).
Link Posted: 9/30/2004 7:37:04 PM EST
I've been on anti-inflammatories for 20 years. For me at least, the only drugs that really work are Ibuprofen and Naproxen. I tried Celebrex for a month and it was useless, and Vioxx for perhaps two months, and was not happy with the outcome. And it is expensive as hell.

I always wondered why Vioxx was so popular since its main claim to fame is that it does not injure the lining of the stomach. I can see taking it if you have a history if ulcers, but if not then why take it?
Link Posted: 9/30/2004 7:48:44 PM EST
VIOXX KICKS ASS! this is just a plot to make me think my spine will collapse!
Link Posted: 9/30/2004 7:54:13 PM EST
My Doc put me on Celebrex after Naproxen wasn't doing much anymore. The first thing I noticed about Celebrex was the lack of stomach iritation.
Link Posted: 10/1/2004 6:37:26 AM EST
Neal Cavuto on foxnews said that the first lawsuit was filed within hours of the official recall being public


Originally Posted By Aimless:
RELEASE THE LAWYERS!!

Link Posted: 10/1/2004 6:44:22 AM EST
if you read the paphlet enlosed in either celbrex or vioxx you'll find a study that shows damn near everyone on ibu long term gets ulcers. that's the main thing these drugs are avoiding.

i had great luck with celebrex for a ripped tendon sheath in my forearm.

i had some vioxx lying around which did a great job on my back spasms.
i wish i had more.

all that stuff is WAY too expensive
Link Posted: 10/1/2004 7:22:30 AM EST
I have had a Vioxx Rx for my shoulder - i stretched some of the cuff pulling up hardwood flooring during a rehab.

I'll miss it.
Link Posted: 10/1/2004 7:28:36 AM EST
I took Vioxx everyday for abour six months untill I started severe abdominal pains. Last week i went for a stress test on my heart and found no problems. No lawsuit for me. The stuff didn't hurt me so I wont be a lawsuit leach. I do hope that anyone seriously injured gets restitution.
Link Posted: 10/1/2004 7:42:47 AM EST
All medications have benefits and side effects. If the benefits outweigh the side effects, its worth it.

If aspirin were subject to same FDA scrutiny as the medications today, it would not have been approved.
Link Posted: 10/1/2004 7:54:04 AM EST
I was prescribed it a few times, back injury, recurruing....it worked like hell. I'm going to miss it.
My bro-in-law just recently brought me a boat load of samples as well........[darn].....they are all goin down the toilet. I was very impressed with it as well. I hate to hear the side effects are so bad......

I need a .50.....my chest is aching........
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