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Recall of Vioxx (rofecoxib) Worldwide
Our family friend, Jaclyn had arthritis. With her active lifestyle, she used Vioxx to ease her arthritis pain since 2001. Even though she eats healthily and exercise daily, and without any family history of heart problem, she died from a heart attack in 2002. Her family was puzzled at that time but never suspected Vioxx. However, ever since the withdrawal of Vioxx from Merck, we felt that Jaclyn's death was caused by the medication. I had been helping the family to do some research and they are now seeking legal advice from an attorney. This article is the result of the research, I hope it will help another family as well.
What is Vioxx?
Reason for Recall of Vioxx
Symptoms
Vioxx Alternative
What You Should Do
Compensation to Vioxx Patients
Compensation to Merck Shareholders
Articles
Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) on 30 Sept 2004.
Vioxx is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID), a class of drugs that may be less likely to cause ulcers and gastrointestinal bleeding than older anti-inflammatory pain relievers, such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn). It is a prescription medicine used to relieve signs and symptoms of arthritis, acute pain in adults, and painful menstrual cycles.
Merck did a study in 2000 that involved some 2,600 people taking 25 milligrams of Vioxx, the maximum recommended daily dose for arthritis pain, or a placebo. The study revealed that an increased risk of cardiovascular complications such as heart attack or stroke among those who took Vioxx for more than 18 months was twice that of the placebo users.
Signs of the serious symptoms of Vioxx can include shortness of breath, chest pains, confusion and impaired thinking, loss of appetite, rapid heart beat, build up of fluid in the body's tissues (edema), and tiredness or fatigue. A negative reaction to Vioxx can also cause stroke, whose symptoms include vision problems, numbness to one side of the body, dizziness, and trouble with speech or motor skills.
The announcement that the drug Vioxx was being pulled from pharmacy shelves because of heart and stroke risks left a lot of pain patients stunned, confused and worried. Some are even wondering if they should abandon medications that are in the same family as 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.
Since the results of clinical studies with one drug in a given class do not necessarily apply to other drugs in the same class, the withdrawal does not suggest that other drugs in the same class are dangerous. 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.
According to Mark Fendrick, MD from the University of Michigan Health System , patients should be treated with medications based in part on their individual risks for heart disease and stomach problems. He created a guide for treating patients' pain with a four-box grid that takes into account risk for heart disease and risk for gastrointestinal problems caused by NSAIDs.
ALL patients should talk to their clinicians about these general guidelines to decide what drugs are right for them and what dose to take!
Choose the box that corresponds to your particular heart (left column) and gut (top row) situation.
| If you have pain... |
...and if you are under 60, have never had ulcers or gastrointestinal bleeding, and aren't taking a blood thinner or oral steroid... |
...and if you are over 60, have ever had ulcers or gastrointestinal bleeding, or take a blood thinner or an oral steroid... |
| ...and your heart risk is low and you don't need to take aspirin regularly... |
Consider a traditional NSAID such as ibuprofen or naproxen. These are available as prescription drugs or over the counter as brand name drugs (Advil, Aleve, Motrin, Nuprin) or as less-expensive store brands that contain the same drug and are just as effective. Acetaminophen (Tylenol or store brand) might also work. |
It's all right to switch to a Cox-II inhibitor other than Vioxx, such as Celebrex or Bextra. Or, you could take a traditional NSAID (such as ibuprofen or naproxen, prescription or over-the-counter), together with a proton pump inhibitor drug (Nexium, Prevacid or Prilosec) to protect your stomach. |
...and if you have risk factors for heart disease (history of heart attack, stroke or chest pain, or smoking, high blood pressure, high cholesterol or family history of heart disease)
|
Try a traditional NSAID, such as ibuprofen or naproxen (prescription or over-the-counter). If you're taking aspirin to protect your heart, you may want to add a proton pump inhibitor drug (Nexium, Prevacid or Prilosec) because of the added gastrointestinal risk that comes from taking aspirin and another NSAID. If you're not on aspirin, ask your doctor if you should be. |
You need to combine an NSAID (such as ibuprofen or naproxen, prescription or over the counter) with a proton pump inhibitor drug (Nexium, Prevacid or Prilosec) to protect your stomach. Or, ask your doctor if you should take acetaminophen or a low-dose non-NSAID painkiller. If you're not on aspirin, ask your doctor if you should be. |
Consumers Union's medical consultants recommend the following steps:
- If you're still taking Vioxx, stop now and ask your doctor to prescribe a different pain medication. Merck says it will reimburse patients for all unused pills; for instructions, go to www.vioxx.com or call 888-368-4699. Experts say the increased risk of heart attack and stroke should disappear once you stop taking Vioxx.
- Discontinue the drug and contact your doctor if you experience gastrointestinal pain or have black, tarry stools, weakness, or light-headedness, which could indicate bleeding.
- Don't exceed the maximum recommended daily dose of any pain-relieving drugs. An earlier study of Vioxx found the highest cardiac risk in patients taking more than the recommended maximum.
- Use these drugs only if they ease the pain. None prevents arthritis or other diseases from getting worse, and they all have risks with chronic use.
FDA encourages anyone aware of a serious adverse reaction to make a MedWatch report. You can report an adverse event in two ways:
You can obtain more information from Merck at:
To find out more about Vioxx from FDA:
- Visit the Drug Information web page at: www.fda.gov/cder
- Call Drug Information at: 888-INFO-FDA (888-463-6332)
Merck says it will reimburse patients for all unused pills; for instructions, go to www.vioxx.com or call 888-368-4699.
If you have been a Vioxx patient, especially for a period of 18 months or more, and have suffered a heart attack, stroke, pulmonary embolism or blood clot during, or following the use of Vioxx, it is possible that you have a legal claim.
Vioxx lawsuits fall under a category known as “product liability”, claiming that the manufacturers of Vioxx (Vioxx lawsuit defendants) or their distributors, knew that the drug could cause harm. There must be proof that the defendants failed to properly provide for the safety of the plaintiff, and that the person filing the Vioxx lawsuit was harmed as a result of the action or inaction of the manufacturer.
Pursuing a Vioxx lawsuit can be a tricky task; most drug companies either attempt to settle, and while a Vioxx lawsuit can mean bad publicity if it goes to trial, it is possible that if the company drags Vioxx lawsuits out indefinitely, the plaintiff will be drained of resources and be forced to settle. Therefore, filing a Vioxx lawsuit is a commitment on the part of yourself and your attorney. Remember, the point of a Vioxx lawsuit is to recover financially the damages you and your loved ones have suffered.
A Vioxx class action suit is brought against the manufacturer of Vioxx by a group of victims who have suffered adverse health problems as a result of taking Vioxx. It is a civil lawsuit in which one or more parties collectively file a suit to seek compensation for their similar injuries as a result of the defective product.
A Vioxx class action settlement is the money that is awarded for medical expenses, loss of income, and pain and suffering caused to all injured parties. This money is then divided accordingly among the victims in a Vioxx class action suit.
Victims of Vioxx class action have a better chance at recovering compensation for their damages at a lower cost to them than if they pursued an individually filed lawsuit. However, the award is divided amongst the plaintiffs and it is possible to receive a lower total amount of compensation in a class action suit than if you were to bring suit against the manufacturer of Vioxx individually.
Merck's withdrawal of Vioxx caused its stock to drop by 25%. There were suspicious trading patterns in Merck securities in the period just before the announcement of the withdrawal, and Merck shareholders are wondering just what the company knew about Vioxx and when it knew it.
The Justice Department has launched a criminal investigation into reports that officials at Merck were aware of the potential cardiovascular risks associated with Vioxx. They are examining Merck’s potential liability for security fraud in connection with Vioxx.
The Securities and Exchange Commission has begun an informal inquiry into Merck's dealings. Their focus is most likely to be whether investors were fully informed by Merck about risks discovered during research of Vioxx.
Finally, the Senate Finance Committee is investigating Merck's relationship with the Food and Drug Administration involving Vioxx
Disclaimer: Content on this site is for reference purposes and is not intended to substitute for advice.
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