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Vioxx pulled from market


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Merck pulls Vioxxacross the globe

Drugmaking giant's stockslumps over 25 on news

The Associated Press

Updated: 10:27 a.m. ET Sept. 30, 2004

TRENTON, N.J. - Pharmaceutical giant Merck & Co. is pulling its blockbuster arthritis drug Vioxx from the market worldwide because new data from a clinical trial found an increased risk of heart attack and stroke. Its stock price plunged more than 27 percent as the company said the action 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.

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 the higher heart risk compared to patients taking dummy pills.

“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. 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 prepared 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.

The analyst 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 high cholesterol drug which 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 dominating the market with about $5 billion in U.S. sales alone last year.

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

Vioxx, launched in the United States in 1999, and a successor drug called Arcoxia, approved in some other countries and awaiting Food and Drug Administration 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.

© 2004 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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Ok, this is bothering me. I wondered about it when the noises started a month ago, but heard nothing since, and there were explanations regarding that study....it was done by a competitor company, you're testing people who are prone to heart attacks anyway due to age, etc.

So I kept taking my Vioxx. Now this. I can't take Celebrex because it contains sulfa and I have had an allergic reaction to sulfa drugs in the past. I did like the Cox 2 enzyme inhibitor thing--I'm trying everything I can to stay healthy. Also, I'm having such muscle aches in my feet and legs that if I'm still for more than a few minutes, I look like Frankenstein when I try to get moving again. Gonna see the onc next month and I guess in the meantime, I"ll quit the vioxx. Last thing I need is a heart attack.

About the aches and pains, though, I have recently read that too much Vit A can cause that.....I am totally overdosed on that and am in in the process of reducing that, but I think it'll take a while to work out of my stystem.

Think I'll ask about trying Celebrex again....had that reaction to sulfa about 25 years ago.

Always something.....


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I was disappointed about this, but I actually quit taking Vioxx after the first wind, about a month ago,.... I figured I would be pretty angry if I had a heart attack, before I could survive cancer...But like most I have aches and pains, (I think it is radiation related) particularly in my shoulder blades around neck, stress like muscle tension stuff, plus the Cox inhibitor thing was appealing, now I guess I will try Celebrex, or maybe plain old Advil.... Anyone gets other ideas let us know...... :lol:

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I took the vioxx for about 1 yr and when I broke my leg in 2/03 they switched me to celebrex.

I did have a hard time with the vioxx anyway! I had bad edema in my ankles, and my B/P went up, I wason B/P meds, and water pills the whole time I was on vioxx. After I started the celebrex I was fine, off the water pills and B/P meds/ Now I am wondering about the pericardial effusion??? Any link to the 50 mg a day I took for so long??

Will have to wait and see.


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Hey Hey...I'm a heart attack kid! Had a heart attack just about at the 18 month mark...a stent then and another stent a couple weeks ago. Cardiovascular disease... if the cancer don't kill me, trying to keep it away will!!!

Down the toilet with the vioxx...I am going back to Naproxen.

See ya in court!

(not really, lawyers bug me)

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