Anyone else on Vioxx?

[Snowflake]

FDA: Arthritis drug linked to heart deaths

Vioxx may triple risk of cardiac arrest, large study shows

Reuters

Updated: 10:29 a.m. ET Aug. 26, 2004

NEW YORK - Patients taking the Vioxx arthritis drug had a 50 percent greater chance of heart attacks and sudden cardiac death than individuals using Pfizer Inc.’s rival Celebrex medicine, according to a large study financed by the U.S. Food and Drug Administration.

Kaiser Permanente, which is one of the biggest U.S. health-maintenance organizations and has more than 8 million members, is reconsidering its use of Vioxx following the study, the Wall Street Journal said on Thursday.

Physician committees from Kaiser will decide how to address the findings, which were based on data from its patients, in the next few weeks, the newspaper said.

A call to Kaiser was not immediately returned.

The study, presented at an epidemiologists conference in Bordeaux, France on Wednesday, is the latest to suggest that the drug increases the danger of heart attacks. Lingering safety concerns have badly hurt sales of Vioxx in recent years.

The study also found patients taking the highest recommended daily dosage of Vioxx had three times the risk of heart attack and sudden cardiac death as those not taking standard painkillers.

Sudden cardiac death, an electrical disturbance of the heart that is not considered a heart attack, is the biggest cause of death in the United States.

Three-fold risk increase

Researchers came up with the potentially damaging findings on Vioxx after analyzing the medical records of 1.4 million people insured by Oakland, California-based Kaiser.

The study found 8,199 heart attacks and cases of sudden cardiac death among the Kaiser members between 1999 and 2001.

Dr. David Graham, lead investigator for the trial, said another major finding was that patients taking the typical starting dose of Vioxx had a 50 percent greater chance of heart attack and sudden cardiac death than patients taking any dose of Celebrex.

“Based upon the evidence in this study, I don’t think doctors should prescribe high-dosage Vioxx, and patients shouldn’t take it,” Graham said in an interview.

Asked if the FDA might consider banning use of high-dose Vioxx, given the findings, Graham said, “The FDA has to decide whether they think a three-fold increase in heart attacks outweighs the benefits of the drug.”

Alise Reicin, vice president of clinical research at Merck, said the study was merely “observational,” and not the preferred formal kind of study in which patients are enrolled and then randomly placed into different treatment groups.

“Observational studies have inherent limitations,” she said, and often produce inaccurate results.

Most patients take daily Vioxx doses of 12.5 milligrams and 25 milligrams for arthritis. But a higher dose of 50 milligrams is approved by the FDA for treatment of pain for no longer than five days.

“The problem is that some patients continue to take it for 30, 60, or 90 days,” Graham said, putting themselves at elevated risk of heart attack and sudden cardiac death.

Graham, senior scientist for the FDA’s Office of Drug Safety, said his own interpretations of the data did not necessarily reflect the views of the FDA.

Comparison “unfair”

In Merck’s own 8,000 patient trial of Vioxx before the drug was launched in 1999, over twice as many arthritis patients taking it had heart attacks and strokes than those who took naproxen -- one of the most popular older arthritis treatments.

Merck has argued that Vioxx itself did not cause the heart attacks but that naproxen was somehow preventing them -- putting Vioxx in an unfair bad light in the head-to-head trials.

But Graham said his trial suggested that naproxen actually slightly increases the risk of heart attacks, casting doubt on Merck’s theory.

Reicin said a group of smaller Merck trials have not shown any greater risk of heart attack for Vioxx than Celebrex.

Although Merck has steadfastly defended the safety of Vioxx, its sales have flattened in recent years amid the lingering safety concerns and cardiovascular risks cited by independent researchers.

That has allowed Celebrex and a sister Pfizer drug, called Bextra, to dominate the market for their class of arthritis drugs, called Cox-2 inhibitors.

The newer drugs are designed to fight inflammation and pain while reducing the risk of ulcers caused by traditional non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, naproxen and ibuprofen.

Copyright 2004 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters.

URL: http://www.msnbc.msn.com/id/5829226/

[Angie Daughter of Bill]

Uh..........yeah. I've been taking it for a heel spur. My dr. had me take 50mg for 10 days, now I am on 25mg. Thanks for posting this. I'll have to ask my dr. about it. (Mostly why she told me to take 50mg for 10 days when FDA says no more than 5 days!)

Angie

[chloesmom]

I'm taking it too--I posted in the NSCLC thread before I saw this....only on 25 mg per day, but I've been doing it for a year now, and I really don't want to quit......grrrrrrr.

[Snowflake]

You may not have to quit taking it,

Vioxx may triple risk of cardiac arrest, large study shows

Print out the article, take it to your doctor (the one the prescribed it) and see if you fall into the risk group for cardiac arrest. If so, have the prescription switched to one of the other drugs mentioned - looks like they're about the same in results, just not side effects...

[mhutch1366]

I have been taking 50 mg/day Vioxx, in combination with MSContin for pain since 2000. I guess I ought to look into this. As with any kind of scientific study, it is only as good as its control groups. In an observational study, you don't have planned control groups. I will check it out, though. (Gawsh I do hate pain.... ).

Thanks for bringing it to my attention.

XOXOXOX

MaryAnn

[chloesmom]

Problem is, I can't take celebrex or it's sister drug because they contain sulfa, and I have had allergic reaction to sulfa.

I will be talking to my doc about this, and hoping that it's just much ado about nothing.

[Cindy RN]

I was on Viox until I broke my leg last Feb 2003. The ortho Dr said to switch to celebrex. Which was great my BP went back down and no swelling in the feet which were side effects of the viox.

Well here lately money has gotten so tight I quit taking the celebrex and started on the Equate brand of Alieve. I think it is naproxen sodium. CHEEP!!! I take 2 in the am and 2 late in the evening and it is doing as well as the Celebrex.

Cindy

[Lyn]

Our pharmacist told me that Naproxen and Aleve are the same thing. If you look at the ingredients on the Aleve bottle, it is Naproxen. The Aleve you can buy over the counter.

I'm glad I read this thread. My husband's doctor prescribed Celebrex for him and he is allergic to Sulpha drugs, too. I didn't know Celebrex had sulfa in it.

Lyn

[twodogs]

Me too. I've been taking 25 mg on and off for a couple years and steady since January. I quit this morning. I've got a Cardiologist appointment next Tuesday and will ask then.

[kimblanchard]

deleting all posts