Merck recalls Vioxx

[Phyllis]

http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#vioxx

Merck Recalls Arthritis Drug Vioxx
Merck Recalls Vioxx Because Data From Clinical Trial Finds Higher Risk of Heart Attack, Stroke

The Associated Press



TRENTON, N.J. Sept. 30, 2004 ? 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.

"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 officer, said in a prepared statement.

 

[catwoman]

For my sister's sake, I'm sorry to hear about this. Nancy has lupus (SLE), which has caused osteonecrosis, and fibromyalgia. Vioxx is one of the few drugs that has given her some relief.
However, it did cause an increase in blood pressure, so she had to rotate off for 6 weeks or so, then go back on.
She's had 1 knee joint replacement, needs it redone and the other done. Had a disk replaced in her back 9/20; she had developed scoliosis in her back after shattering a hip @ age 42 when ****** off-balance by her dog who was on a leash.
I have seen my sister in excruciating pain for 6+ years. I hope there will be another, safer drug to replace Vioxx for her.

 

[Eloise]

Holy Cow!!! Vioxx was the only drug that worked to keep my arthritus under control.I hope Catwoman,that your sister finds an alternative pain medication.If I find one or hear of one,I'll post it.

 

[hensylee]

I think our Nancy takes Vioxx. Wonder how far behind Celebrex is. I take that one.

Al, do you know the similarity of these two drugs - their content?

I had a time getting my stomach to accept Celebrex. all nsaids have a tendency to bother the stomach lining.

So often we are hearing of the danger of drugs that are supposed to help us, have no/little side effects - but then end up injuring or killing us. Scary, isn't it.

 

[Granbonny]

It's been running on CNN every 30 minutes all day..with doctors being interviewed. They would not suggest another medicine. Just said, stop it..it's not a drug you have to be weaned off...See your doctor. CEO of Merck was on..Said they got the news late Tuesday night. And released the info as soon as possible...Of course..the interviews have been running..Law suits, ect. and their stock (Merck)went way down today. I called my neighbor(Home in South Ga. helping hubby recoup from OHS 2 weeks ago. She had already heard about it and has an appointment for herself tomorrow to see her doctor. Been on it for back pain. Just heard on the news you would have to been on it for 18 months for a 50 % chance of a heart attack.. They said, 1st lawsuit was filed 4 hours after it was announced today. Afraid Merck's in big trouble. For those on it or have friends. listen to news...I'm sure it will # 1 on all Evening news other than the debate tonight. Bonnie

 

[Eloise]

I've been taking Vioxx for three years! I found that Celebrex made me gain weight,Flexerall(sp?) made me soooooo totally stoned(not that I minded except I have to work to support myself,not a good combination)and now...now..I learn that I finally find a way to manage chronic pain...and I exaberated my medical condition even more??????????? Cripes.Un-Real.I again am thankfull to vent here at this forum.I honestly believed that dealing with heart disease was enough,I"d never dare mention all my other ills(is that wrong,abnormal??? I don't know seemed selfish or something) To already KNOW you have so many risks to cope with as it is...one more...simply stinks.Time to listen to music.Thanks for letting me vent.

 

[Nancy]

Joe tried it a while back, but it caused his CHF to become much worse. Large fluid gains. He had to go off it, thank God.

This is going to affect so many, many people. It was a VERY popular drug.

 

[Bryan B]

Vioxx was the only non-narcotic drug that relieved my sternum pain, but (fortunately I guess) my stomach did not tolerate it well and I only took it for a couple of weeks. I agree, this recall is going to leave a lot of people hurting...literally.

 

[Harpoon]

I caught a brief on this while driving to my art class (40 minute drive) this morning on NPR. They didn't say why it was pulled, just that it was pulled for causing health problems in people who took it long term. I suspected it was heart related...


Hopefully they can either reformulate the drug to take out whatever component affects the heart or they can find a good alternative for it. I know a LOT of people take it all the time and that's a big hole to fill all of the sudden.


Some medications I know get "reissued" with revised warnings and different dosage recommendations based on studies such as this. Perhaps, for some people, a risk/benefit analysis can be done to show if the increased risk of heart attack or stroke would outweigh the benefit of the drug.

EVERY medication has side-effects. Most are fairly small and can be well tolerated by most people, some however are more serious than the condition the drug is intended to treat and therefore alternatives are found.

Amiodarone is like that. I know it's been discussed a lot here and it's sort of a "double-edged sword" kind of drug. One the one side, it seems to be pretty effective in controlling heart arhythmias for many people and can have some great benefits, however prolonged use can cause all kind of bad things to happen to your body including liver and kidney problems, blindness, hearing loss and even death. It's a potent drug that has a clear benefit for some, but also comes with a lot of risk that has to be considered before putting a patient on it.


Tough choices.

 

[Rich]

For those dealing with Vioxx and more you might want to read the e-mail I received today.
Vioxx, Other "Super Aspirins" Are Super Disasters - Other Cox-2 Alternatives Have Safety Problems Too

Statement by Sidney M. Wolfe, MD, Director of Public Citizen's Health Research Group, Concerning Withdrawal of Vioxx From the Market

Today's announcement by Merck is the latest evidence that this family of drugs, the Cox-2 inhibitors, once referred to as "super aspirins," are turning out to be more like super disasters.

In an article published three and a half years ago in our monthly newsletter, Worst Pills, Best Pills News (now online at http://www.WorstPills.org/vioxxqd/ ), we warned readers that both Vioxx and Celebrex were DO NOT USE drugs - our designation for drugs that are not safe and effective enough to use. Although Merck's withdrawal of Vioxx "solves" the serious safety problems with this drug, the most-prescribed alternatives, Celebrex and Bextra, also have some concerns about their cardiac toxicity.

If you were subscribing to WorstPills.org you would have advance warning about these and other prescription drugs. For more information on how to subscribe to this valuable online publication, follow this link:
https://www.worstpills.org/subscribe.cfm?src=17

To read the complete press release, follow this link:
http://www.citizen.org/publications/release.cfm?ID=7333


Public Citizen's Health Research Group
http://www.citizen.org
http://www.questionabledoctors.org

--------------------------------------------------------------------------------
Public Citizen fights for the rights of the individual citizen in the halls of power and leads the battle to strengthen public health, safety, and environmental protection. To retain our independence, Public Citizen does not accept government or corporate funds. For more information about Public Citizen, visit http://www.citizen.org.

 

[cherieo]

Drugs: evil but necessary

Drugs: evil but necessary

It seems that for every drug I take I have to take another to offset the side effects ie.. Lasix/Potassium. I stopped taking Vioxx because it cause acute renal failure. I don't take celebrex because of my CHF. I have used Ultram without any problems and am now taking Ultracet which works even better and still no side effects. Has anyone tried these or heard anything about them. Cherieo

 

[catwoman]

Talked to my sister Nancy tonight. She said she stopped taking Vioxx not long ago -- BP hit 180/120, I think she said. She's an RN, so I think she'd remember BP numbers pretty well ...

 

[LUVMyBirman]

I was once presrcibed Vioxx. After reading the side effects....which were clearly marked. It mentioned something about effecting the heart. Hello and goodbye! Same thing with Imitrex. One should proceed with caution. Honestly, I would rather suffer a bit and remain amongst the living!

 

[tobagotwo]

The study specifically doesn't indicate that people with a short-term use of Vioxx have an issue. If someone is using it for a couple of weeks after surgery for inflammation, there is no evidence that there is any negative cardiovascular involvement, apart from those who don't tolerate it well, and have one of the side effects already noted with the prescription.

Not good for those many who use it long-term to control pain and inflammation. My heart does out to those who must now face switching to another medication, especially when one has to wonder whether Celebrex has similar issues.

Best wishes,

 

[Marge]

The New York Times story in its front page story today said that there were "15 cases of heart attack, stroke, or blood clots per thousand people over three years" for people taking Vioxx. There were 7.5 such cases for people taking a placebo.

So, there was a 50 % increase over the number of coronary events for people on Vioxx over people on a placebo. But that still means only 7.5 additional people (per thousand) having coronary incidents in three years who were taking Vioxx. I don't know -- if I were in intense pain, and no other pain reliever had helped, maybe I'd be willing to risk being one of those 7.5 people. 7.5 in a thousand? It might still seem like not bad odds as opposed to a life of pain.

 

[Eloise]

Out of curiosity I went to a few web-sites concerning lawyers and class action law suits pending against Merck.Of the few I looked at, all of them had a questionaire to fill out.I laughed and laughed when the first question was "Are you dead?"