VIOXX Alert!

[CCTAU 3,326]

Merck Halts Worldwide Sales of Vioxx

1 hour, 1 minute ago  Business - AP

By LINDA A. JOHNSON, AP Business Writer

TRENTON, N.J. - Pharmaceutical giant Merck & Co. is halting worldwide sales of its blockbuster arthritis drug Vioxx, once viewed as possibly being able to prevent some cancers, because new data from a clinical trial found an increased risk of heart attack and stroke. Its stock price plunged more than 26 percent as the company said the recall will hurt its earnings.

Merck said Thursday that data from the trial showed the increased risk of heart attack and other cardiovascular complications began 18 months after patients started taking Vioxx. About 2 million people worldwide are currently taking Vioxx, according to Merck, and a total of 84 million have taken it since it came on the market with great fanfare in 1999.

The data comes from a three-year study aimed at showing that Vioxx at a 25 milligram dose prevents recurrence of polyps in the colon and rectum. Such polyps can turn cancerous. The trial was stopped after Merck discovered study participants had double the risk of a heart attack, compared to other participants taking dummy pills.

Medical experts advised patients to stop taking Vioxx and consult their doctor about alternatives, but said patients should not panic because the risk of a heart attack was still relatively low.

"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.

Vioxx is one of Merck's most important drugs, with $2.5 billion in sales in 2003 — about 11 percent of the company's $22.49 billion in revenue that year. But sales dipped 18 percent in the second quarter of this year to $653 million, partly due to increasing concerns about the drug's safety.

"We're taking this action because we believe it best serves the interest of patients," Ray V. Gilmartin, Merck's chairman, president and chief executive, said in a statement.

"Although we believe it would have been possible to continue to market Vioxx with labeling that would incorporate these new data, given the availability of alternative therapies and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take," he said.

Merck, the world's third-biggest drug maker, announced the news before the stock market opened. In morning trading on the New York Stock Exchange (news - web sites), Merck shares plunged $11.98, or more than 26 percent, to $33.09.

Shah said the withdrawal of Vioxx comes "at a time when they really need to get ready for expiration" of its patent for Zocor, a drug for high cholesterol that is Merck's top-selling drug. Zocor loses patent protection early in 2006 and sales are expected to plunge when generic competition begins. In an effort to replace those revenues, Merck recently launched a drug with partner Schering-Plough Corp., Vytorin, that combines Zocor and Schering-Plough's Zetia to attack cholesterol levels in two complementary ways.

"This makes it almost inevitable for the company to find a merger partner for them to continue to grow," Shah said.

Merck's announcement stands to benefit rival Pfizer Inc., the world's biggest drug maker. The two companies 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 17 cents to $30.35 in early trading on the NYSE.

"I think Celebrex sales are going to significantly increase," Shah said.

Vioxx and a successor drug called Arcoxia, approved in some other countries and awaiting Food and Drug Administration (news - web sites) approval here, are part of a class of anti-inflammatory drugs heavily touted by the pharmaceutical industry as being more effective and having less side effects, particularly on the gastrointestinal system, than older drugs.

Pfizer's Celebrex and its successor drug, Bextra, which already is on the market in the United States, also are in that class, called cox-2 inhibitors.

"This has never been the massive innovation which was promoted to be," Shah said of the drug class. "In terms of pain relief, these drugs are no better than ibuprofen and they cost 10, 15 times more."

He said it is possible the news, along with some prior reports about heart risk and gastrointestinal bleeding linked to the drugs, could push some patients to go back to older, cheaper drugs.

Shah also said physicians prefer ibuprofen more than Celebrex and Vioxx combined.

The company said the Vioxx recall will slash about 50 cents to 60 cents a share from its earnings for the rest of this year. That includes foregone sales, writeoffs of inventory held by Merck, customer returns of product previously sold and other costs of the pullback. Merck expects foregone fourth quarter sales of Vioxx of $700 million to $750 million alone.

Merck, which is based in Whitehouse Station, N.J., had previously been expecting 2004 earnings per share of $3.11 to $3.17.

Merck is scheduled to release financial results for the third quarter, which ends today, on Oct. 21.

[jared52 4,354]

Let Turd Furgason tell you about his little experience with Vioxx... not pretty.

[Ranger12 46]

That really sucked because I have two bulging disks in my back that I am scheduled to start having spinal injections for, but I have had to put them off because of my job until the end of October. In the meantime I had started taking Vioxx for my back to help ease the pain and so far, it had been the only pill that works decently. Now they take it away from me and so I am going to be put on Celebrex until I start the spinal injections. Let me tell you guys something, of all the injuries I have had in my life (broken bones, knee injuries, etc), this back problem is the worst crap I have ever had to endure as far as injuries go.

[TitanTiger 20,482]

Have you used Celebrex before? It's a pretty good medication. Might also try Bextra. Both are Pfizer drugs.

[Ranger12 46]

Have you used Celebrex before?  It's a pretty good medication.  Might also try Bextra.  Both are Pfizer drugs.

106827[/snapback]

I had been on a Bextra for awhile, but it helped very little. I just started taking Celebrex for the first time yesterday, so we will see how that works. I go for my consulation for my spinal injections on Oct. 22, so I will know more about that then. My doctor feels confident that the injections will improve my situation. My back problems is what has kept me from being able to go back into the military in an infantry capactity. I was diagnosed with a stress fracture back in 2000, which the doctor believes I had for years already, probably from my days as a soldier. That developed into arthritis and now have two beautiful matching pair of bulging disks.

[CCTAU 3,326]

Have you used Celebrex before?  It's a pretty good medication.  Might also try Bextra.  Both are Pfizer drugs.

106827[/snapback]

I had been on a Bextra for awhile, but it helped very little. I just started taking Celebrex for the first time yesterday, so we will see how that works. I go for my consulation for my spinal injections on Oct. 22, so I will know more about that then. My doctor feels confident that the injections will improve my situation. My back problems is what has kept me from being able to go back into the military in an infantry capactity. I was diagnosed with a stress fracture back in 2000, which the doctor believes I had for years already, probably from my days as a soldier. That developed into arthritis and now have two beautiful matching pair of bulging disks.

106876[/snapback]

Better bulging than ruptured. The epidurals should help. But you can only have a maximum of three in like 6 weeks. If they don't help, you probably have more going on than just a bulging disk. I read a report several years ago that Vioxx and Celebrex both increased the risk of heart attack. The basic claim to both was that they were both easier on your stomach. Seems that naproxen and ibuprofen should do the same job. These drugs are really nothing new but have hade such a marketing expense that people think they are. They were making the drug companies rich. Merck is now in trouble. Regardless, any of this stuff taken for a long time can harm your internal organs. Go get your epidurals (my wife just had another Friday) and see if that wil help. Don't go doing anything stupid the first couple of days if you feel really good. The pain meds added in the injection wil wear off. Then you will know if it really worked or not. Its basically just a local anti-inflamatory application. Good luck with it. Lumbar fusions are not fun. So avoid it as long as you can.

[Ranger12 46]

Fortunately for me, my wife is in the medical field as an x-ray tech and she works in a doctor's office, so she has prepped my on what to expect. I would have gotten the epidurals sooner, but because of a some changes with my job in having to become more familiar with a new client, I had to put if off for a couple of months. It was a gamble in doing that because of the fear that the disks could rupture, but sometimes you got to do what you got to do.

Yeah, the disks are bulging because of the inflammation created by the arthritis and stress fracture that apparently will not heal. The possible pain does not bother me because it can't be any worse then what I already feel, but the inconvience of being shut down for a day does bother me.

[Turd Ferguson 38]

I was prescribed Vioxx for pain when I had ACL reconstruction in 2003...the Vioxx caused my body to react violently and I developed a condition called Steven Johnson Syndrome. It basically caused huge purple wepls to pop up all over my body and if it hadn't been caught in time and the Vioxx intake halted in time, then it would have caused sloughing of the mucus membranes, blindness, and eventually death as the Vioxx was just feeding the fire.

It's dirty and bad.....the Vioxx.

[Turd Ferguson 38]

I was prescribed Vioxx for pain when I had ACL reconstruction in 2003...the Vioxx caused my body to react violently and I developed a condition called Steven Johnson Syndrome. It basically caused huge purple wepls to pop up all over my body and if it hadn't been caught in time and the Vioxx intake halted in time, then it would have caused sloughing of the mucus membranes, blindness, and eventually death as the Vioxx was just feeding the fire.

It's dirty and bad.....the Vioxx.