Arthritis Drug 'Vioxx' Yanked Off Shelves
Thursday, September 30, 2004
http://kyw1060.com/news_story_detail.cfm?newsitemid=40781
Arthritis Drug 'Vioxx' Yanked Off ShelvesPharmaceutical 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.NJ-based 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. The trial was stopped after Merck discovered the higher heart risk compared to patients taking dummy pills.
(See information at the bottom of this article on how to get a refund for Vioxx you have purchased.)
Merck chairman Ray Gilmartin said the company is recalling Vioxx because it "best serves the interest of patients."
One industry analyst say calls this a disaster for Merck.
Vioxx is one of Merck's most important drugs, with $2½ billion dollars in sales in 2003.
But sales dipped 18 percent in the second quarter of this year, partly due to increasing concerns about the drug's safety.
Investors were bailing on the stock. Merck shares were down heavily in New York Stock Exchange trading, dragging the Dow Jones Industrial Average -- of which it is a component -- along with it.
KYW's medical editor Dr. Brian Mcdonough says millions of people currently take Merck's drug Vioxx:
"In fact, it is their 'blockbuster' drug. If you were going to look at Merck's top drugs, it is one of the most-widely-prescribed drugs they make. And just about every doctor I know has patients on it to treat arthritis, degenerative joint disease, and those problems. So it's definitely a big choice out there. Of course it's being pulled now, so we as physicians are now all scrambling and saying: 'OK, what can we put our patients on that is going to help the symptoms but not put them at any risk like this?' "
Dr. McDonough says patients taking Vioxx should talk with their personal physicians:
"If you're someone who's on the medicine now -- and a lot of people are -- what you need to do is not panic. You need to call your doctor and think of other options. Stop taking it. Just don't take it because you've got 10 left in the bottle or whatever. But talk to your doctor about a substitute. And please don't be turned off to (other) anti-arthritis medications. Realize there are many safe ones. This is one specific drug in a specific group. There are many other things we've used for years that are safe."
Dr. McDonough explains that the latest bombshell findings came to light during an unrelated study:
"What happened was, they were looking at the dose that we prescribe for Vioxx and looking at the fact that it helps prevent colon cancer. And they were trying to prove that it helps prevent polyps and those things. There had been indications that double the normal dose there might cause subtle heart problems. They had known that. But they felt at the regular dose it was safe. As they were studying the colon cancer effects, they noticed this increased risk in heart attacks and stroke in patients 18 months after they had been taking it. So when something like that happens and you're talking about a medicine that there's dozens of other things that we can use that work effectively, morally and from an ethical standpoint they have to let us know so we stop using it -- and I think that's the key issue."
Read more medical reports from KYW's Dr. Brian McDonough
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Patients can get a refund on unused Vioxx by mailing back the remaining drug in the original container, along with a pharmacy receipt, to:
NNC GroupMerck Returns2670 Executive Dr.Indianapolis, IN 46241
A note with the patient's name, address, and phone number should be included.
The company will reimburse the cost of the full prescription plus regular shipping.
More instructions and information are available through the Internet at www.vioxx.com and www.merck.com, or by calling 888-368-4699, toll-free.
Doctors are being asked to send back samples, and pharmacists will be contacted by Merck representatives on returning unsold inventory.
posted by Anh at 7:54 PM
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