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Vioxx Injury
Vioxx has been removed from the market in all countries because it has been associated with heart attacks, stroke, cardiovascular injuries and other serious side effects. According to Merck, about 2 million people worldwide are currently taking Vioxx, and a total of 105 million people have taken it since it came on the market in 1999. Vioxx safety concerns include the increased incidence of blood clots tied to strokes and heart attacks found in multiple Vioxx clinical studies.
If you or a loved one has taken Vioxx, it is important that you speak with a Vioxx attorney about the possibility of a Vioxx claim. Call your injury lawyers at Holzer Edwards, Chartered (208) 386-9119 to speak with a Vioxx attorney to evaluate your Vioxx claim absolutely free. You may be entitled to compensation. If Vioxx has injured you or a loved one, our Vioxx legal team will aggressively fight for your rights.
The Recall Of Vioxx
Merck & Co., Inc. announced September 30th a voluntary withdrawal of Vioxx (chemical name rofecoxib) from the U.S. market due to safety concerns. Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by the Food and Drug Administration (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. It is also approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.
The FDA was informed by Merck & Co., Inc. on September 27, 2004, that the Data Safety Monitoring Board for an ongoing long-term study of Vioxx (APPROVe) had recommended that the study be stopped early for safety reasons. The study was being conducted in patients at risk for developing recurrent colon polyps. The study showed an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx compared to placebo, particularly those who had been taking the drug for longer than 18 months. Patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo. Based on this new safety information, Merck and FDA officials met the following day and, during that meeting, the FDA was informed that Merck was voluntarily withdrawing Vioxx from the market place.
As far back as June 2000, Merck submitted to FDA a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) that found an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking Vioxx compared to patients taking naproxen. In April 2002, after reviewing the results of the VIGOR study and other available data from controlled clinical trials, the FDA implemented labeling changes to reflect the findings from the VIGOR study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke. Vioxx remained on the market, however, and no action was taken by Merck.
The Vioxx recall has the potential to create hundreds of thousands of Vioxx claims against Merck. If you think you may have a Vioxx claim or have used Vioxx in the past and are unsure, call your injury lawyers at Holzer, Edwards & Harrison (208) 386-9119 to speak with a Vioxx attorney who can evaluate your Vioxx claim.
Questions Regarding Vioxx
The recall of Vioxx affects millions of current and former Vioxx users. These current and former Vioxx users are sure to have many questions relating to Vioxx and where to get help. The following Vioxx questions and answers are here to help you sort through the Vioxx questions you may have and if you are a current or former Vioxx user, will help you decide if you have a possible Vioxx claim that you should speak with a Vioxx attorney about.
What is Vioxx? Vioxx (rofecoxib) 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.
Did the FDA require the withdrawal of the drug? No, Merck made the decision to remove the drug from circulation independent of input from the FDA. The FDA had not reviewed the data from the study that was stopped in the depth that Merck has, but has indicated it agrees with the company that there appear to be significant safety concerns for patients, especially those taking the drug chronically.
What action did the FDA take? FDA issued a public health advisory concerning the use of Vioxx. This advisory is based on Merck’s voluntarily withdrawing Vioxx from the market due to safety concerns.
What should I do if I am taking Vioxx? Talk to your doctor, immediately. 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. We also advise you to contact us IMMEDIATELY so that we can review with you your legal rights.
What are the possible long-term health effects, if any, of taking this product? The new study shows that Vioxx causes an increased risk in cardiovascular events such as heart attack and strokes during chronic use.
What evidence supports this alleged health risk? 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 a 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.
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 resultsfor the first 18 months of the trial allegedly did not show any increased risk of confirmed cardiovascular events on Vioxx.
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 allegedly 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.
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.
Does Merck's action mean other drugs in the same class are dangerous? The results of clinical studies with one drug in a given class may indicate risks associated with 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.
For more information:
You can obtain more information from Merck at:
www.merck.com and www.vioxx.com
To find out more about Vioxx from FDA: Visit www.fda.gov/cder.
If, after reading the Vioxx questions and answers you wish to gain more Vioxx information, or you feel you have a Vioxx claim that you want to speak with a Vioxx attorney about, call your injury lawyers at Holzer Edwards, Chartered (208) 386-9119 to speak with a Vioxx attorney who can evaluate your Vioxx claim.
Vioxx’ History
Vioxx was recently recalled from the market due to unnecessary health risks placed upon its users. Vioxx was created by Merck and launched in the United States in 1999. Since Vioxx was launched in 1999, 91 million prescriptions for the drug have been written in the United States alone. In the past few years, Vioxx sales have been flat amid safety concerns worried about the increased incidence of blood clots tied to strokes and heart attacks found in clinical studies. Nothing was done until the latest clinical study administered by Merck established the increased chance of heart attack or stroke from using Vioxx. ONLY THEN did the company recall Vioxx (September 30th, 2004).
The FDA approved Vioxx (also known as Rofecoxib) in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain. It was the second of a new kind of nonsteroidal anti-inflammatory drug (NSAID) approved by FDA. Subsequently, FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children. When it was approved, it was hoped that they would have a lower risk of gastrointestinal ulcers and bleeding than other NSAIDs (such as ibuprofen and naproxen). Vioxx is the only NSAID demonstrated to have a lower rate of these side effects.
If you are currently using Vioxx, or have used Vioxx in the past, be sure to get the Vioxx information you need in order to know the risks Vioxx placed upon your health. Call your injury lawyers at Holzer, Edwards & Harrison (208) 386-9119 to speak with a Vioxx attorney who can evaluate your Vioxx claim.
Vioxx Side Effects
Vioxx was created to combat the effects of osteoarthritis (OA) and rheumatoid arthritis (RA). When Merck introduced Vioxx in 1999 it was an unparalleled scientific breakthrough in this area. Vioxx was heralded as the future of pain medications and was rushed to the shelves by both Merck and the FDA.
Osteoarthritis and rheumatoid arthritis are among the most prevalent chronic illnesses and leading causes of disability in the United States. The enzymes responsible for these two illnesses are named COX-1 and COX-2, and have been the target of arthritis therapy using nonselective NSAIDs. An understanding of the COX enzymes has allowed for the development of agents that specifically inhibit COX-2. COX-2-selective inhibitors work similar to NSAIDS, but have a lower potential for upper gastrointestinal injury, a serious side effect of nonselective NSAIDs. COX-2-selective inhibitors represent a significant advance in the treatment of arthritis and other related inflammatory conditions. Science has found that the ability to inhibit COX-2 while sparing COX-1 can provide therapeutic benefits in the management of pain and inflammation, without the comparatively negative effects on the integrity of upper gastrointestinal tract. Vioxx is one such COX-2 inhibitor (Celebrex and Bextra are other examples).
The chemical make-up of Vioxx allows for therapeutic benefits with less upper gastrointestinal injury, but it has been found to cause an increase in the chance of a heart attack or stroke. As a result, Vioxx was pulled from the market. If you are a currently using Vioxx, or have used Vioxx in the past, be sure to speak with a Vioxx attorney about a possible Vioxx claim. Call your injury lawyers at Holzer Edwards, Chartered (208) 386-9119 to speak with a Vioxx attorney who can evaluate your Vioxx claim.
The Science Behind the Drug
Vioxx was created to combat the effects of osteoarthritis (OA) and rheumatoid arthritis (RA). When Merck introduced Vioxx in 1999 it was an unparalleled scientific breakthrough in this area. Vioxx was heralded as the future of pain medications and was rushed to the shelves by both Merck and the FDA.
Osteoarthritis and rheumatoid arthritis are among the most prevalent chronic illnesses and leading causes of disability in the United States. The enzymes responsible for these two illnesses are named COX-1 and COX-2, and have been the target of arthritis therapy using nonselective NSAIDs. An understanding of the COX enzymes has allowed for the development of agents that specifically inhibit COX-2. COX-2-selective inhibitors work similar to NSAIDS, but have a lower potential for upper gastrointestinal injury, a serious side effect of nonselective NSAIDs. COX-2-selective inhibitors represent a significant advance in the treatment of arthritis and other related inflammatory conditions. Science has found that the ability to inhibit COX-2 while sparing COX-1 can provide therapeutic benefits in the management of pain and inflammation, without comparatively negative effects on the integrity of upper gastrointestinal tract. Vioxx is one such COX-2 inhibitor (Celebrex and Bextra are other examples).
The chemical make-up of Vioxx allows for therapeutic benefits with less upper gastrointestinal injury, but it has been found to cause an increase in the chance of a heart attack or stroke. As a result, Vioxx was pulled from themarket. If you are a currently using Vioxx, or have used Vioxx in the past, be sure to speak with a Vioxx attorney about a possible Vioxx claim. Call your injury lawyers at Holzer Edwards, Chartered (208) 386-9119 to speak with a Vioxx attorney who can evaluate your Vioxx claim.
Merck’s Liability To Those Injured
Vioxx, an anti-inflammatory drug, was pulled from the market because of the increased risk of heart attacks and stroke present from the use of Vioxx. The drug was FDA approved and many health studies had been conducted before Vioxx was allowed onto the market, but these current health concerns were either overlooked or ignored.
Each year hundreds of new drugs enter the $60 billion per year prescription-drug industry promising to improve our lives. However, 200,000 Americans die every year and numerous more are injured as a result of false and misleading claims by pharmaceutical companies. Despite the series of clinical trials and tests conducted on prescription drugs to protect the public, many drugs are causing serious injuries.
Fortunately, the law provides you with rights. Under §402A of the Restatement (Second) of Torts, prescription drug manufacturers can be held strictly liable for selling products in a defective and unreasonably dangerous condition, even though they may have exercised the utmost care in the preparation and sale of their product. A product may be defective or unreasonably dangerous in several ways. One way is if the manufacturer failed to warn consumers of potential injury risks associated with the product. A product might also be defective or unreasonably dangerous if it was improperly designed (i.e. inappropriate chemical composition or dosage). Finally, the product may also be defective if an error occurred during the manufacturing process. A prescription drug contains a manufacturing defect when it departs from its intended design even though it was carefully prepared and marketed. Manufacturer liability may also extend to what your physician tells you about the prescription drug. If you are currently using Vioxx, or have used Vioxx in the past and have experienced any health problems because of Vioxx, be sure to speak with a Vioxx attorney about a possible Vioxx claim. The drug maker and maybe even your physician can be held responsible for their ill-advised actions. Call your injury lawyers at Holzer Edwards, Chartered (208) 386-9119 to speak with a Vioxx attorney who can evaluate your Vioxx claim.
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