Merck Withdraws Arthritis Drug Vioxx

http://story.news.yahoo.com/news?tmpl=story&ncid=716&e=1&u=/ap/20040930/ap_on_bi_ge/arthritis_drug_recall


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.



Whitehouse Station-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.


"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.

This should NEVER have gone on the market. I freaked when I heard the warnings on the commercial about side-effects. Where was the FDA on this?

That's why people should research them before taking them. The package inserts provide a list of the side effects and their relative frequency.

As far as the FDA goes, the approval process is more stringent and thorough than most people realize.

The process does not, however, always consider multiple-drug interactions. The study Merck quoted involved using Vioxx in post-cancer-treatment patients. Cancer meds and chemo counteract with tons of drugs.

I'm not a cancer patient and developed severe hypertension from Vioxx...stopped the Vioxx..BP went back to normal

Reading inserts and warnings is nice but there are more warnings on an insert for tylenol than many of these newer drugs.

Many people use more than one doctor and more than one pharmacy, and they don't bother mentioning that fact to any of the doctors or pharmacies involved. In that case, it is most certainly the patient's responsibility to be informed about potential side effects.

"Reading inserts and warnings is nice but there are more warnings on an insert for tylenol than many of these newer drugs."

I'm sorry, but you're wrong. Drug interactions and warnings are very thorough, because the FDA requires that they be so. You apparently haven't really looked at one lately, because they are pages and pages long and include study information, usually in excruciating detail.

Here's Vioxx, for example - http://www.rxlist.com/cgi/generic/rofecox.htm

And here are the side effects: http://www.rxlist.com/cgi/generic/rofecox_ad.htm

Warnings: http://www.rxlist.com/cgi/generic/rofecox_wcp.htm

Etc., etc.

Good luck finding that level of detail on Tylenol.

By the way, hypertension is one of the best-known negative side effects of Vioxx - studies have linked the two for at least 3-4 years. You didn't mention whether or not you had a history of hypertension prior to Vioxx, but if you did, your doctor should have never put you on it in the first place.

Many people use more than one doctor and more than one pharmacy, and they don't bother mentioning that fact to any of the doctors or pharmacies involved. In that case, it is most certainly the patient's responsibility to be informed about potential side effects.

Only if you are promoting a DOC IN THE BOX relationship. Otherwise a doctor should ASK for a complete list of medications a patient is taking. To do otherwise is CLEARLY malpractice and falls below the standard of care


I'm sorry, but you're wrong. Drug interactions and warnings are very thorough, because the FDA requires that they be so. You apparently haven't really looked at one lately, because they are pages and pages long and include study information, usually in excruciating detail.

I read them all the time...are you going to tell me that every patient should have a graduate level understanding of chemistry as well?


By the way, hypertension is one of the best-known negative side effects of Vioxx - studies have linked the two for at least 3-4 years. You didn't mention whether or not you had a history of hypertension prior to Vioxx, but if you did, your doctor should have never put you on it in the first place.

what part of went back to normal was unclear for you?

The point is - people should not blindly assume that their doctors or hospitals are perfect. People make mistakes, including the patients.

Doctors do ask patients for a list of medications, at least in my experience. However, many, MANY patients intentionally withhold information because they don't want their doctors to know that they are being treated for another condition by another doctor.

It's called "doctor shopping". It's a huge problem and has been well-documented in the media. It's the cause of a significant number of fatalities every year. A doctor can't account for information that the patient either intentionally or unintentionally withholds.

Not to mention that people forget. If your dentist gives you pain medication for a tooth problem, do you always remember to tell your medical doctor about it at your next appointment? My guess is that most people don't even think about the connection.

Chemistry? Oh, please. What kind of degree does it take to understand, "VIOXX can cause discomfort and rarely, more serious side effects, such as gastrointestinal bleeding, which may result in hospitalization and even fatal outcomes."

If you can read English, you can understand that statement. Most of the rest of the warnings and patient information are similarly understandable. I'm not saying read and understand the whole thing. I'm saying be informed about what we're taking instead of being willfully ignorant.

Besides, you said that there was not enough information in the inserts. I only pointed out that this claim was inaccurate. So, which is it? Not enough information or too much? Pick one, please.

You have a choice. You can either be ignorant or you can be informed. Considering that thousands - or tens of thousands - of people die every year because of drug interactions or doctor or hospital screwups, it seems to make perfect sense for the patient to bother taking a little responsibility instead of relying on blind faith in the system. Plus, if you know what the potential side effects of a medication are, you can be better prepared for them should they occur.

"what part of went back to normal was unclear for you?"

"A history of hypertension" could include a family history, not just whether or not you happened to be "normal" immediately prior to taking Vioxx. In addition, "Normal" is often not a permanent condition. You could have been "normal" because you were on long-term hypertension medication. In that case, you could have had "normal" blood pressure for years, but still shouldn't be anywhere near Vioxx.

if the only thing it's good for is to have an excuse for preventing people from purchasing drugs from other countries because they "might not be safe", the same drugs the FDA happily approves for sale in this country by big-pharma Republican donor corporations?

Oh, you thought they were concerned about human health? (Sorry.)

professional responsibility. It is no more the patient's responsibility to know drug interactions than it is the Boxster owner's responsibility to know how to service a mid engine vehicle. The vast majority of the population is not medically sophisiticated and that SHOULD be fine if their medical professionals are competent.

There is a difference between consumer warning labels and inserts and inserts are not always provided to patients.

It's not a matter of taking things personal. When someone on a public message board implies that people should know complex medical issues, I will be quick to point out that that is not the case.

And I made it clear I had NO history of hypertension...try working with what is in front of you.

after SS is privatized. What the hell are we paying all these taxes for if the regulatory agencies don't do their job. The pharmacists are more concerned over not filling birth control pills than tracking drug interaction.
I am a cancer survivor! I do have arthritus. I don't believe this is the first arthritus med that has been recalled. I take NOTHING if it's not vitamin, herb or anything natural. I am very aware of how my body reacts to anything that I put in my mouth including food.
The doctors are so stretched for time they asked no questions and if you don't SEE the same doctor everytime at an HMO there are too many chances this will happen.
I was the one whom determined I was allergic to ALL antibiotics.This is the only life you have right now. Trusting anyone besides yourself it crazy.

You have a choice. You can either be ignorant or you can be informed. Considering that thousands - or tens of thousands - of people die every year because of drug interactions or doctor or hospital screwups, it seems to make perfect sense for the patient to bother taking a little responsibility instead of relying on blind faith in the system.

Except that this is a system that FORCES me to shell out money to a government-designated professional before I may have the privilege of shelling out even more money to buy whatever said professional chooses to prescribe. I, like most people in this country, am FORBIDDEN to decide outright which medication I would rather take, no matter how extensively I may have researched my options. How in hell can I be "responsible" for decisions that are kept almost entirely out of my hands in the first place?

Responsibility follows from actual control. If I must accept the degree of responsibility that you indicate, then I DEMAND the abolition of the prescription-only system that strips me of control over my health.


Mary

I'd like to ask you why it is you think that Vioxx is being pulled, then, since in your world, the onus is on the owner of the anus with the polyps, and no pharm. company should be held responsible.

My great-grandfather (92) sees a cardiologist, an arthritis specialist, an audiologist, a podiatrist, a geriatric nutritionist and a neurologist. They each prescribe different drugs for different treatments; it's up to my sisters, my grandmother, my mother and my grandfather's caregiver to make sure he's not getting bad interactions.

However, to maintain his quality of life, he must see all of these specialists - especially the podiatrist and the arthritis specialist.

He's not doctor shopping or having a "doc in the box" relationship. His GP (who is 82 and has been his GP for 50 years) can't treat him as well as the specialists can. While these docs to take into account all of the medications he's on (which are relatively few, considering his age and condition) the podiatrist may not be familiar with the cardiac drugs he's on, and the nutritionist may not be familiar with the interactions with the cognition drug he's on.

Or are you suggesting that his medical needs are somehow less important than those of others? That he should just suck it up and live in pain? He likes living. He wants to hang around a bit longer and see how the story ends. Who are you to criticize how he and we manage his health?

Pcat

I understand and agree with patients having multiple specialists..especially older patients

They are not nearly as stringent as they should be with regards to the elderly and drug interactions. She was hospitalized once because of a parkinsons drug, and even when she went into the hospital for the final time, her behavior was very strange, and the doctor said he thought it was the pain medication. When I pointed out to him that she was not on pain medication, he didn't even reply.

As much as I don't want to say it, some of her caretaker's attitudes toward her at the end were "she's going to die anyway, so what does it matter." It was so disappointing.

When getting a prescription of any kind, the pharmacist types up a label and sticks it on the outside of a generic pill bottle. I’ve never seen anything other than the date, brief doctors instructions (take x pills y times a day), the drug name and strength, and a barcode. Sometimes theres a warning not to operate dangerous machinery while taking pills.

If I want prescribing information such as comes in the bottle the pharmacist dispenses from (or is printed in the PDR or in links like you offered), I have to ask the pharmacist, who then gives me an “oral” presentation of dangers, interactions, etc.

Yes, a bottle of Tylenol has much more info printed on it by the manufacturer than any typed label I’ve seen from a dispensing pharmacist.

In my 40+ years I have yet to see either a physician or pharmacist hand out zerox copies or printouts of “prescribing” information from the manufacturer of any prescription drug.

Many people use more than one doctor and more than one pharmacy, and they don't bother mentioning that fact to any of the doctors or pharmacies involved.

Just ask Rush Limbaugh!

This is a sad fact of the drug approval process and in my professional opinion acceptable because drugs can't be tested in large numbers of people prior to approval. The best that can be done is to test in controlled studies to see what the anticipated effects are going to be. Drugs are tested in limited numbers of "subjects" and not until the drug is approved and on the market that some adverse reactions are noted, especially if given off label or with combinations of drugs that weren't used in the clinical trials. This clinical trial that showed cardiac issues shows that the drug company did the correct thing by pulling the drug from the market.

One other point I would like to make. Anytime someone uses a drug and they experience an adverse event the person needs to report the event to their physician, which in the case of nothingshocksmeanymore likely did. The next step is the patient or the physician (or both) need to complete a MedWatch form and report the event to the FDA. It is the responsibility of all participants (physician, patient and other health care providers) to report adverse events to the FDA for drugs currently approved and on the market. This is a little known fact for some reason. I think most physicians know about the form but are too busy to complete it. Most consumers are unaware of the form because they are not informed by their physicians and the drug companies haven't informed the consumers and the FDA has not informed the consumers.

For more information concerning MedWatch go to:
http://www.fda.gov/medwatch/index.html

as were problems with Rezulin. The revolving door between the FDA and corporate scientists and physicians is one of the reason more dangerous drugs are getting to market.

in the US. Unfortunately when a drug is approved and people have severe reactions it makes all of those involved in the drug approval process look bad. For the most part we who are involved in clinical trials want the best data to come out of the trials, be it good or bad. I don't want any drug I work on to get approval if it is going to cause harm. I should qualify the last statement since I work mostly on oncology projects and the drugs I work on do cause harm but that is the nature of chemotherapy. Maybe one day with targeted cancer therapies we can eliminate most of the harmful affects. I hope that day is soon!

I work within the pharmaceutical industry so I do have my biases but I would not trust any company wholeheartedly because there is too much money at stake. Also as a consumer and someone who takes an occasional medication, I want the best drugs out on the market for their intended use.

and granted fast track was supposed to get life saving meds to the public faster especially in cases of cancer and aids...but it also fast tracked meds that were not "lifesaving" ...and again, the risks outweigh the benefits in many cases.

The docs may be so busy, etc. You can do this for vet pharmaceuticals too. My vet wouldn't so I did it myself. I think a hell of a lot of drug effects are never reported, especially vet meds.

got hypertension, this must just be all in your head.

Another feather in the cap of animal testing.

You seriously trust the FDA this much? For the past half decade or more, FDA has been asleep at the switch, or worse, under the influence of big pharma money at the switch. The downard spiral in FDA's oversight began with the push for fast-track approval of HIV drugs. Fast track can now be had for lots of compounds, and the scientific review boards within FDA can be bought off or shut up at the corporate sponsor's whim. Once FDA began taking big pharma's money to hasten the approval process, it was all over for consumer protection. Maybe this is why such a huge portion of FDA's "lifers" have fled the agency in recent years.

Consumer protection from FDA oversight is a joke. Might as well just trust the drugcos to protect consumers, since they pull the strings at today's FDA.

most of the people at FDA are ex-pharmaceutical types and these drugs have a way of getting pushed through the system. Patients be damned. The show started with a diet drug as I recall and they found young women were dying at way more than the normal %. This one doctor who noticed the connection got in touch with the Mayo Clinic and they started tracking the drug and its effects. After they stated their findings on TV there was the big investigation and the FDA looked at the data and then the drug was pulled from the market. Lots of people think the FDA is protecting you but there are a lot of things slipping through; the drugmakers are paying for these studies and also paying the FDA. The studies by the drugmakers then have a tendency to come out the way the drugmakers want.

If there weren't the threat of litigation Merck would not have taken this action.

This was new information concerning safety and it was the company's obligation to report it to the FDA. Plus I am sure their was a Clinical Safety Monitoring Board reviewing all adverse events for the study and they would have had an obligation to report the adverse events to the FDA.

from new research indicating that some of the enw arthritis drugs were not any better at relieving pain than ibuprofen. The researchers' conclusion was that people should take those drugs only if they are prone to having gastrointestinal problems from ibuprofen.

The report said most doctors didn't know about the latest research because they are too busy to find these reports that have been downplayed by publishers, and the pharmas were working overtime to get the doctors' attention for their drugs.

I'm really glad I can get by without taking much.

About 3 weeks ago I told my doctor I didn't want to take it anymore because I heard on ABC News about the risk of stroke and heart attacks. He then prescribed Mobic as a replacement.

My Mom had a stroke 5 years ago and it's been hell for both us. She was 86 when she had the stroke and it wasn't related to any drug but, I'm afraid. Thanks for posting.

it killed my stomach! Phew, I am glad you are off of it now!

Hubby's doctor tried to switch him to this medication. Free samples everywhere. Hubby tried it for a week , said it didn't work and changed back to another medication. I prefer medications that have been around 25 years or more.

Should have done these trials before it got to market. Pharma's just don't give a damn.

What most people (doctors included, unfortunately) do not understand is that drugs—all drugs—act differently on different people, so that a drug that helps one person might have no effect at all on another. The pioneer genetic pharmacologist (whose name escapes me at the moment) says that his research shows that any given drug will be useless for about 1/3 of the population. That is why doctors often have to try multiple drugs on you before finding one that works. (For example, it took four tries to find a blood pressure drug that actually lowered my blood pressure.)

I have tried Vioxx for arthritis pain. It is about as effective for me as drinking water. In other words, no apparent effect at all. On the other hand, my daughter, who was in a car wreck four years ago, had to take it for a while for whiplash. It was so powerful for her that she only took half a pill at a time and got significant pain relief from it.

I use aspirin for pain relief. My son uses ibuprofen. A friend uses acetaminophen. We each chose our OTC drug on the basis of how well it did what we wanted it to. I have never found ibuprofen or acetaminophen to be at all effective, which is why I stick with aspirin.

just reported on the news. Anyone currently on Vioxx is to contact their Dr. since immediate cessation can cause problems.

as noted above, i wonder how much the fear of litigation made the decision for Merck?

dp

while taking that drug. She was only 57.

Anyone have rhuematoid arthritis? What are you taking? I was taking Vioxx now Mobic. In addition I take 6 Methotrextrate's once a week, Plaquenel, Mobic, and Folic Acid once a day.

Have also tried Embril injections. The pain drives me to take these drugs but, I'm willing to suffer some pain in exchange for something less toxic. My neighbor is a pharmacist and she said the Plaquenel and Methotrextrate are going to kill my liver. I see the dr. every 6 weeks and he does blood work.

I'm half tempted to throw all these freaking pills out!

on edit: With the last visit he also put me on Altace because my b.p. is up. Don't know if it's from the stress of dealing with my Mom or this freakin election. :(

It's either take this crap and go bankrupt in the process or die a slower death in agony and look forward to being wheelchair bound. I am on prednisone, methotrexate,diclofenac. Thru the years I have tried other NASAIDS,gold injection etc. All I know is the pain will always be there and so will the co$t of those damn drugs.

My son is on prednisone for arthritis in his back.

Hang in there :hug:

It's a horribly painful disease. My mother-in-law had crippling arthritis and there seem to be no real answers.

For years I have had fibromylagia, which is something quite different, but also lacks any kind of definitive cure.

My rheumatologist said cognitive behavioral therapy can help fibro. My therapist is using it with me, and I'm doing things from the book "Feeling Good" by David Burns. I didn't think it would do a thing, but amazingly, my pain has decreased recently. I'm told it's from release of inner anger and stress.

I don't know whether will work on arthritis, but if there's even the slightest chance it could help you, I'm posting this for you.

Feel better!

My blood pressure has always been low. I mean, almost-dead low. Lately every time I see the doctor it is high. He said it was probably due to the pain, but thinking back---this all started when I started taking Celebrex every day-for osteoarthritis in my back. In addition I get cortisone injections, and take glucosamine, and valium and pain meds when I absolutely need it.

It could be a coincidence, or most likely be my past bad habits catching up with my body; or it could be the combination of the different drugs, or stress, or something, so: I'm not going to freak out. I'm not going to freak out. I'm not going to freak out.

And here I've been singing "Celebrex and Vioxx are MIRACLE drugs!" I should have known it was too good to be true.

I was just getting used to being pain-free without opiates as the norm instead of the exception; and I have accomplished so much in these months that I don't want to go back. I'm looking MUCH further into this situation and talking to my doctor.

accupunture... I had my first treatment today and it went great! I go again next week and let you know how I progress.

I asked him about treating RA and he said absolutely you are a candidate!

peace,
lc

My eldery mom who has heart problems has gotten lots of free samples. I will call her right away. Several people I know were given this to subdue attacks of shingles too.

She had congestive heart failure. She took Vioxx for 3 days for some knee pain. Ended up in the hospital and gravely ill.
Scared us to death.
I'm glad they pulled this one.

Back in 2001 my dad started taking Celebrex for his arthritis. In June the doctor for no apparent reason switched him to Vioxx, and in a week he was dead from a heart attack. He was 51, and there was no family history or anything. He was in such good shape the EMT's thought he was ten years younger than he really was. At the time there were already a bunch of class action lawsuits over the drug, but we didn't know about it until afterwards.
I guess it's not really news to anyone at this point, but if you are taking Vioxx, stop. Really.

that helps my pain. oh well, what can you do.

..the financial market. Screw the people, it's the stocks and corporate profits that matter.

They had a commercial running with a teacher building a pinata, and praising the drug. I noticed that they changed the tag line right before the drug was being questioned, to something like "I talked to my doctor, and I'm sticking with Vioxx" or some such. I guess they pulled that commercial today!

I think anyone who was harmed by this drug has potential for a well-justified lawsuit. I'll bet we'll see a class action effort before too long.

bury Merck. This drug accounted for a significant portion of their profits.

Too bad, I'll miss my Vioxx.

You've got to watch out for yourself when seeking medical treatment, because Lord knows the medical establishment isn't looking out for you.

Now someone is going to post something about how hard physicians work and blah blah blah ... that's not what I'm talking about. This is the BIG PICTURE. Good doctors get polluted by bought-n-paid for journal articles and fuzzy clinical trials.

or are involved in some way in medicine? By the way what is a "fuzzy" clinical trial.

I read of a study done recently where it asked doctors what year of medical history they thought that a patient would have been more helped than harmed by medical treatment, and to my dismay, the consensus was that the medical profession became more helpful than harmful around 1950. Egads!

It is horrible how the two previous generations equate doctors with God, like if you went to heaven, God would look like your GP. It's a Norman Rockwell fantasy effect, and it may come from when the doctor was a shaman/spiritual leader-healer/ and medicine woman or man from the tribe. With every lawsuit that helps people see anyone in the medical profession with cynicism instead of unearned respect, the safer we will be.

was essentially a way for Merck to sell an NSAID at outrageous prices through prescription.
Vioxx is also no more effective than Advil (from WebMD):

"Larry Sasich, PharmD, MPH, of the consumer advocacy organization Public Citizen, tells WebMD Vioxx and Celebrex "are no more effective than other NSAIDs, and there appears to be no safety advantage". Arthritis patients would be better off financially and medically taking a cheaper NSAID, such as ibuprofen, which are a fraction of the price of the COX-2 inhibitors."

friend admitted to me she's a whore. Docs call her in middle of night for samples for "dog's arthritis" wink wink...

they are just drug pushers and the docs do no research on their own.

Is Celebrex next? Cause it is a miracle drug for my arthritis.

What the hell is the FDA doing these days? Just stamping everything "approved" without clinical trials? Doing research BEFORE the drug is released serves the interests of patients, assholes.

It was on the MSNBC stock market show. It wasn't totally clear what that meant - but Celebrex is said to be the same basic chemical as Viox (COX inhibitor).

EOM

I took Vioxx for about ten days, it seemed to have no effect. I had no history of high blood pressure or any heart problems, but I had Congestive heart failure soon thereafter( I thought out of the blue) I spent all summer recooping. I still have the sample boxes of unused Vioxx. I am taking Bextra now but it's not a great pain reliever.

they tried to put me on vioxx a few years back, i tried it for a few weeks, and other drugs, now i just deal with the pain, cut back as necessary. i have changed my diet and lifestyle, the daily pain is nothing compared to the unknown side effects.

Consider why Vioxx was created in the first place: as an alternative (as in, mandatory-- if piss-poor -- "alternative") to the highly effective opiate pain medications that would, in a sane world, be the first choices for treatment of persistent pain.

For the anti-drug fanatic, a bunch of oldsters dropping dead of heart-attacks is a small price to pay for a pharmacologically pure society. Letting those geezers have medicines that they might actually enjoy taking would be terrible! They must be spared the threat of medically-induced bliss at all costs. A catastrophic, vegetablizing stroke is much to be prefered to the dread Spectre of physical dependency in an otherwise healthy and well-rounded grandma.

We must sacrifce EVERYTHING to the War on Drugs. Health, wealth, sanity, decency, grannies -- EVERYTHING must go.


Mary

filed on thier asses.

RC