Vioxx–Facts That You Should Know


 

 

You should be concerned if you had used Vioxx and had suffered either a heart attack or stroke. Use of Vioxx might have caused it. You should also be concerned if you have been taking it for a long time (at least 18 months) because it might have increased your risk factors.

It is now thought that long term use of Vioxx may double one’s chances of a heart attack or stroke. According to an estimate in the October 21st issue of the New England Journal of Medicine, tens of thousands of users may have had “major adverse events” attributable to the drug.

Merck & Co., Inc., the drug’s manufacturer, voluntarily withdrew Vioxx from drugstores as of September 30, 2004. Vioxx is a popular arthritis and acute pain medication.

Merck removed Vioxx from the market after three years of colon cancer trial studies confirmed long-standing concerns that long term users of the medication were at twice the risk of suffering a heart attack or stroke.

The Food and Drug Administration (FDA) encourages patients who are currently using Vioxx to contact their physicians immediately to discuss discontinuing use of Vioxx as well as the prescription of alternative medicines.

It has been estimated that 20 million Americans have taken Vioxx by the time of the recall. The number of users worldwide may go as high as 60 million. Vioxx was earning Merck $2.5 billion annually and was the second most popular painkiller after Celebrex ($3 billion annual sales). Merck had spent more than $500 million over the years to advertise it. As reported in the November 1st issue of Fortune, Vioxx was one of Merck’s “blockbuster” drugs launched in the 1990’s which include Fosamax for osteoporosis and Singular for asthma.

Even though Merck hailed it as a new miracle drug there was always a cloud hanging over Vioxx. Before the FDA approved the compound, researchers outside Merck found evidence that it, and similar drugs (COX-2 inhibitors), might increase the risk of heart attack. In 1998 researchers at the University of Pennsylvania discovered that COX-2 inhibitors interfere with enzymes which ward-off cardiovascular disease. Merck said that this study was inconclusive. In early 2000, Merck reported results from a trial which Merck sought to show that Vioxx caused fewer gastrointestinal problems. The patients had three times as many cardiovascular events than those taking naprsoxen which is sold as Aleve. Again, Merck said that the results were inconclusive.

In April, 2002, Merck updated the Vioxx package insert to include the warning of increased risk of heart attack. Merck then commenced a long-term study of the heart risks. This study resulted in the recall. On September 23rd Merck’s chief of research told his CEO that patients who have taken Vioxx for at least 18 months have a higher rate of heart attack. Merck immediately recalled the drug on September 30th.

Merck has come under much criticism, all of it justified. Eric Topol, MD, chairman of cardiology at the Cleveland Clinic said in the New England Journal of Medicine that “had the company not valued sales over safety, a suitable trial could have been initiated rapidly at a fraction of the cost of Merck’s direct-to-consumer adverting campaign.” In 2001 Dr. Topol had been one of a number of researchers who raised questions about safety. He offered to visit Merck to present his detailed analysis of the risks. Merck never took-up the offer.

Therefore, people who have taken Vioxx and who have suffered either heart attacks or strokes may have a case against Merck. Long term users who have not had heart disease should be concerned and should be checked by their doctors.

We recommend that you call us as to whether you have a potential case worth investigating. Please contact our office by calling (800) 581-1434 with any questions.

Frequently asked questions about Vioxx

Q: What is Vioxx?

A: Vioxx is a popular pain medication invented, patented, and sold by Merck. It is used primarily by arthritis suffers.

Q: Is Vioxx the only type of painkiller on the market?

A: No. Vioxx is one drug within a class of drugs known as COX-2 inhibitors which reduce pain and inflammation without the side effects of common in ibuprofen, such as ulcers and gastrointestinal bleeding. The ibuprofen type of drugs are called nonsteriodidal anti-inflammatory drugs (NSAIDs). Aleve is a NSAID drug. By some estimates intestinal bleeding caused by NSAIDs kill more than 10,000 Americans annually.

Q: If I have been taking Vioxx, are there other painkillers available?

A: Yes, there are other COX-2 inhibitors, such as Celebrex. Also, there are the NSAIDs. If you have been taking Vioxx you must consult with your physicians to see which drug is suitable for you.

Q: I have taken Vioxx for 3 years, and I had a heart attack earlier this year. Do I have a case?

A: You may have a case, and it is worth investigating. Merck’s own studies state that use of Vioxx for at least 18 months can result in increased rates of heart disease. Of course, there may be other factors causing heart disease, such as smoking and obesity. The client’s medical history must be reviewed fully.

Q: I have taken Vioxx for 3 years, and I have not had either a heart attack or stroke. My last exam at the cardiologist was fine. Do I have a case?

A: If you have no signs of heart disease, then you have no injury, and it is unlikely that you have a case. In any event, you should consult with your physicians to determine your further course of medical action.

Q: How would Merck be legally responsible if I were injured?

A: Merck may be liable under a number of legal theories. One theory is that it failed to warn of the risks when it had reason to know that there were such risks. Under the failure to warn theory, Merck would be responsible for failing to warn of the heart attack risk in its many television and print advertisements. Another theory is strict liability, i.e., the manufacture and sale of an inherently dangerous product.

 

   
 
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