Vioxx Recall Info
Vioxx®
Brand Name: Vioxx®
Active Ingredient:   rofecoxib
Strength(s): 12.5mg & 25mg tablets or 12.5mg/5ml & 25mg/5ml suspension
Dosage Form(s):   Tablets and oral suspension
Company Name:    Merck & Co., Inc.
Availability:         Prescription only
*Date Approved by the FDA:   May 21, 1999
*Approval by FDA does not mean that the drug is available to consumers at this time.

What is Vioxx used for?

Vioxx is used to relieve:

  • Signs and symptoms of osteoarthritis
  • Acute pain in adults
  • Painful menstrual cycles.

Who should not take Vioxx?

You should not take Vioxx if you have experienced asthma, hives, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). A few examples of other NSAIDs are ibuprofen, naproxen, diclofenac, nabumetone, and ketoprofen.

Special Warnings with Vioxx:

Serious problems from stomach ulcers, such as bleeding, are well-known complications in people treated with NSAIDs. Similar problems have occurred in people treated with Vioxx, although very rarely. The likelihood of stomach problems increases the longer you take drugs like Vioxx. However, even short-term treatment is not without risk. These problems can happen without any warning, but in some people may cause symptoms such as gnawing or burning stomach pain, black or tarry stools, or vomiting. If this happens, stop taking Vioxx and call your health care provider right away.

Check with your health care provider. Vioxx may not be right for you, if you:

  • have had ulcers or stomach bleeding
  • have had asthma, hives, or allergic-type reactions after taking aspirin or other NSAIDs
  • have severe kidney problems
  • have severe liver problems
  • are pregnant

General Precautions with Vioxx:

Do not stop taking any medications that you have been prescribed without first talking to your doctor.

Serious problems such as liver damage have occurred in people treated with NSAIDs. Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss of appetite, itching, yellow coloring of skin or eyes, "flu-like" symptoms and dark urine. If you experience any of these symptoms, call your health care provider right away.

Vioxx can cause your body to retain fluid and swell. Your health care provider will decide if Vioxx is right for you, if you:

  • retain fluids
  • have high blood pressure
  • have heart failure

If you have asthma, you may have aspirin-sensitive asthma. If an aspirin-sensitive asthmatic takes aspirin it can cause severe narrowing of the airway (bronchospasm), and even death. Since this type of reaction to aspirin and other NSAIDs have occurred in aspirin-sensitive patients, Vioxx should not be given to aspirin-sensitive patients.

The safety and effectiveness of Vioxx in patients below the age of 18 years has not been determined.

What should I tell my doctor or health care provider?

Tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.

Because certain other medications can interact with Vioxx, review all medications that you are taking with your health care provider, including those that you take without a prescription.

Your health care provider may have to adjust your dose or monitor you more closely if you take:

  • certain blood pressure medications called ACE-inhibitors
  • furosemide
  • lithium
  • methotrexate
  • rifampin
  • warfarin
  • aspirin

Avoid taking Vioxx with antacids that contain calcium carbonate and magnesium/aluminum combination products, because they may reduce the amount of Vioxx your body absorbs.

What are some possible side effects of Vioxx? (This is NOT a complete list of side effects reported with Vioxx. Your health care provider can discuss with you a more complete list of side effects.)  

Side effects can include:

  • Upper respiratory tract infection
  • Diarrhea
  • Nausea
  • Heartburn
  • Swelling of the lower legs or feet
  • High blood pressure

Rarely, serious ulcers have occurred in patients taking Vioxx.

For more detailed information about Vioxx, ask your health care provider.


Vioxx Being Pulled - Merck Vioxx Recall

9/30/2004

Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx. Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms. Vioxx was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.

Vioxx (rofecoxib) Questions and Answers

1.     What action did Merck take today? 

Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib).

2. What is Vioxx?

Vioxx is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID). Vioxx is also related to the nonselective NSAIDs , such as ibuprofen and naproxen. Vioxx is a prescription medicine used to relieve signs and symptoms of arthritis, acute pain in adults, and painful menstrual cycles.

3. Did FDA require this action?

No, Merck made this decision independent of input from FDA. The Agency has not had an opportunity to review the data from the study that was stopped in the depth that Merck has, but agrees with the company that there appear to be significant safety concerns for patients, particularly those taking the drug chronically.

FDA plans to work closely with Merck to coordinate the withdrawal of this product from the US market.

4. What action did FDA take today?

FDA issued a public health advisory concerning the use of Vioxx. This advisory is based on Merck & Co., Inc. voluntarily withdrawing Vioxx from the market due to safety concerns.

5. What should I do if I am currently taking Vioxx?

The risk that an individual patient will suffer a heart attack or stroke related to Vioxx is very small. We encourage people taking Vioxx to contact their physician to discuss discontinuing use of Vioxx and alternative treatments. Any decision about which drug product to take to treat your symptoms should be made in consultation with your physician based on an assessment of your specific treatment needs.

6.  What are the likely long-term health effects, if any, of taking this product?

The new study shows that Vioxx may cause an increased risk in cardiovascular events such as heart attack and strokes during chronic use.

7. What evidence supports the Public Health Advisory?

Merck’s decision to withdraw Vioxx from the market is based on new data from a trial called the APPROVe [ Adenomatous Polyp Prevention on VIOXX] trial. In the APPROVe trial, Vioxx was compared to placebo (sugar-pill). The purpose of the trial was to see if Vioxx 25 mg was effective in preventing the recurrence of colon polyps. This trial was stopped early because there was an increased risk for serious cardiovascular events, such as heart attacks and strokes, first observed after 18 months of continuous treatment with Vioxx compared with placebo.

8. Why wasn’t the APPROVe trial stopped earlier?

The APPROVe trial began enrollment in 2000. The trial was being monitored by an independent data safety monitoring board (DSMB). It was not stopped earlier because the results for the first 18 months of the trial did not show any increased risk of confirmed cardiovascular events on Vioxx.

9. What did FDA know about the risk of heart attack and stroke when it approved Vioxx?

FDA originally approved Vioxx in May 1999. The original safety database included approximately 5000 patients on Vioxx and did not show an increased risk of heart attack or stroke. A later study, VIGOR (VIOXX GI Outcomes Research), was primarily designed to look at the effects of Vioxx on side effects such as stomach ulcers and bleeding and was submitted to the FDA in June 2000. The study showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking naproxen, another NSAID, however, the study also showed a greater number of heart attacks in patients taking Vioxx. The VIGOR study was discussed at a February 2001 Arthritis Advisory Committee and the new safety information from this study was added to the labeling for Vioxx in April 2002. Merck then began to conduct longer-term trials to obtain more data on the risk for heart attack and stroke with chronic use of Vioxx.

10. Is FDA’s expedited review process putting riskier drugs on the market?

No. Vioxx received a six-month priority review because the drug potentially provided a significant therapeutic advantage over existing approved drugs due to fewer gastrointestinal side effects, including bleeding. A product undergoing a priority review is held to the same rigorous standards for safety, efficacy, and quality that FDA expects from all drugs submitted for approval.

11. What other drugs are similar to Vioxx?

Vioxx is a COX-2 selective, nonsteroidal anti-inflammatory drug (NSAID). Other COX-2 selective NSAIDs on the market at this time are Celebrex (celecoxib) and Bextra (valdecoxib). Vioxx is also related to the nonselective NSAIDs, such as ibuprofen and naproxen. You should consult your physician to determine which treatment is right for you.

12. Does today’s action suggest that other drugs in the same class are dangerous?

The results of clinical studies with one drug in a given class do not necessarily apply to other drugs in the same class. All of the NSAIDs have risks when taken chronically, especially of gastrointestinal (stomach) bleeding, but also liver and kidney toxicity. Patients using these drugs for a long period of time (longer than two weeks) should be under the care of a physician.

13. Will Vioxx be recalled?

FDA did not request a recall of Vioxx.  This product is being voluntarily withdrawn from the market by Merck.

14. Can my pharmacist continue to fill my prescription for Vioxx?

No, Merck is initiating a market withdrawal in the United States to the pharmacy level. This means Vioxx will no longer be available at pharmacies.

15.  How can I report a serious side effect with Vioxx to FDA?

FDA encourages anyone aware of a serious adverse reaction to make a MedWatch report. You can report an adverse event in two ways:

  • Visit www.fda.gov/medwatch and click on "How to Report"

  • Call 1-800-FDA-1088

16. Where can I get more information?

You can obtain more information from Merck at:

  • www.merck.com and www.vioxx.com , or

  • 1-888-36VIOXX (1-888-368-4699)

Search the Web for more info:  


Recent Forum Posts on Vioxx

Vioxx

I have had 2 arthroscopic surgeries on my knee, leaving me with no cartilage, inability to bend my knee to 90 degrees, and chronic pain which has totally disrupted my lifestyle. When a regime of Celebrex failed, I was given Vioxx 25mg with some relief, but not long lasting. The joint replacement surgeon recommended surgery & increased the Vioxx to 2-25 mg pills/day. I have only been on this dosage a few days, but have remarkable relief. The swelling is down, the pain is more controlled &, while I don't consider this a long-term "fix", I feel 110% better than I have since I fell. I only hope this relief doesn't wear off as my body metabolizes the increased dose. I am amazed and delighted with the results thus far.


Vioxx and Zomig

I just took Vioxx and Zomig for the first time yesterday and I took them together. I am unsure if what happened to me was related to the medications, but the doctor couldn't find anything wrong with an MRI. I started throwing up and had some memory loss, confusion, and feeling "out there". I looked at my kids and all I could do was stare at them. I woke up today and felt fine (did not take either medicine) and later in the morning, I felt the same as I did last night except for the severity and throwing up. I have been having migraines and headaches constantly and I do take Stacker 2's a couple of times a week. Could this be the result of those two medications? If anyone has any advice, please email me.


Vioxx - Side effects???

I am on my way to my new Rheumatologist tomorrow. I have been on Vioxx for arthritis for about a year & 1/2....and for the last 6 months have had terrible pains in my legs. Finally, my new GP, suggested I drop Vioxx for awhile as he felt it might be contributing to my high blood pressure.
So I stopped. GUESS WHAT?!. I have not had severe leg pains since.

Now, I am not sure any of this is connected, but I sure am suspicious!

Oh yes, and I have been bothered all year by swollen eyes!


No Subject

I would be very interested to find out if anyone else out there has had a heart attact that may be constrewed as being vioxx induced. I had no problems prior to using this product and have only recently seen an ad in a magazine stating that heart attact is one of the possible side affects of taking vioxx. Six weeks after starting the drug I had a total blockage in the circumflex with no other blockages or buildups. At the time I was told to stop taking the drug immediatly because it was possible that it was vioxx that caused it.


No Subject

after taking viox for aback problem , ifelt great pain free for aweek the following week istarted to experiance anxiety to which i had to seek medical advice. i was wondering if any one else has experienced such an effect, as i cannot find this reaction to the medication as a side effect.


Vioxx Side Effects

A knee specialist put me on Vioxx (one 25 mg per day) for 4 weeks due to pains in my left knee.

I was only on it 3 days and stopped it immediately. Not only did it feel like it was eating up my stomach but it made me retain fluid and I gained 5 1/2 pounds in only 3 days time!!

Since stopping it, the stomach pain has left and the scale is going back down. I think I would rather live with the knee pain than take risks with Vioxx again.


dont take vioxx read

my mother started takeing vioxx in 2000 she was also takeing high blood pressure medication.she died 2001 of a massive heart attack.we have since found out that vioxx killed her. the fda not to long ago released new warnings that were not avable when my mother started taken it.it causes heart blockages and heart attacks and high blood pressure pills dont mix. so everyone beware please or you could loose a loved one just like that.


No Subject

Had great, awesome pain relief in the knee, but suffered such severe back pain (equal to that of passing a kidney stone), I had to stop taking it.


No Subject

I was taking Vioxx because I fell & strained some tendons. I had terrible results, vomiting was the least of it. I also have asthma, which didn't help. The pain was alleviated by Celebrex & I would never recommend anyone to take Vioxx.


'Cold like symptoms'

Vioxx has been wondeful for relief from the arthritis in my ankle. I sure regret it when I stop taking my Vioxx!

I almost continuously have a cold. Sneezing, coughing, itchy eyes, burning sinuses. What is strange is that this cold doesn't seem to be 'passed' onto others in my family and rarely goes away.

Unfortunately I've finally come to the conclusion that this must be the "respiratory tract infection" side-effect mentioned. I've seen other sites call the side-effect 'cold-like symptoms'.

Anyone else experience these symptoms? Does anything help to reduce the cold-symptoms while taking Vioxx?


No Subject

I have osteoarthritis and a prior gastric bypass. My surgeon told me not to take NSAIDs because I didn't have much of a stomach left to risk ulcers with. I was put on Vioxx for the osteo and in 3 days noticed my feet and ankles beginning to swell. I gave it a good two-week trial; the pain didn't go away, and the swelling escalated to pretty much whole body. I really got panicky when I noticed that I wasn't making very much urine anymore and had gained weight. I stopped the Vioxx, took a diuretic, and lost 18 pounds of water in 24 hours! It's on my list of drugs never to take again.


Vioxx

I have been medicating for moderate/severe joint pain(rotater cuff). I lieu of surgery I had tried the OTC pain meds and Celebrex with NO effect at all. Prior to submitting to surgery, ugh, I learned of Vioxx which the doc then prescribed. The 12.5 dose was not effective but the 25 mg/1 day curbed the pain like magic and I thought all was well. Not! I discovered that after a few weeks my new symptoms of palpatations and tingling (in my hand/arm) were listed side effects. I've since stopped using Vioxx. The palps and tingling disappeared thereafter. I will forestall surgery as long as possible; maybe the New Year will bring an alternative to the knife.


Vioxx for menstrual cramps

I took it for arthritis, and since I was told not to take it with other NSAIDS, when I got my period I just kept taking the Vioxx. And then I ended up in the ER for more bleeding than I've ever had in my life. I will never take this drug again. I can't believe the FDA actually approved it for menstrual cramps! I can't believe there isn't a lawsuit going yet, and if I ever hear of one, I'm signing on. I spent days in bed waiting for the bleeding to stop because every time I got up it would get worse. I have never had that sort of problem in the past and I am convinced that my use of Vioxx played some role in it.


leg pain

I have been on Vioxx for three months for my back.My back feels better but my legs are killing me. After reading some of the comments other people have made i think i'll get off it and see if my achy legs feel better.


No Subject

Could not take Vioxx. Took one and feet and legs swelled terribly bad. I had been taking Celebrex but it made me swell too, so thought I would try Vioxx. The Vioxx was much, much worse. Went back to Celebrex (being very careful to take with lots of food)


Vioxx

I pulled 2 ligaments in my ankle and got Vioxx 50mg for the pain. I did experience elevated blood pressure and fluid retention but for me it was woth it because it made the pain go away. My doctor told me that when I stop taking the Vioxx both of those side affect will go away. When I don't take the Vioxx I can't move around at all. I am very happy with the results from taking the medication and would recommend it to anyone who suffers chronic pain like I've gone through for the past 3 weeks.


Vioxx and Fosamax

I ended up in emergency room with terrible burning, gnawing pain in my stomach/gut area. It had been going on since I started taking Vioxx along with my Fosamax. The emergency room doctor told me to stop taking both immediately. The pain is still there, but certainly not as bad. Beware. Vioxx is powerful and can be toxic. If you have any burning at all in your stomach area, get off the stuff. AND, be advised it is not a good idea to mix Vioxx with Fosamax.


No Subject

I have experienced weight gain and fluid retention with Vioxx. Not worth the side effects! I have had swelling in my eyes also.


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