Merck & Co. has removed 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. Merck said it decided to removed the drug from the market after data from the trial showed the increased risk of heart attack, stroke, blood clots and other cardiovascular complications .
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.
Before the withdrawal of Vioxx®, the FDA announced that patients taking Vioxx® have a 50 percent greater chance of heart attacks and sudden cardiac death. The study, presented at an epidemiologists conference, also found patients taking the highest recommended daily dosage of Vioxx® had three times the risk of heart attack and sudden cardiac death as those not taking standard
painkillers.
The popular and heavily advertised arthritis drugs Vioxx® and Celebrex have been linked by researchers to an increase in the risk of blood clots, heart attacks and strokes.The study from the Cleveland Clinic appeared in the Journal of the American Medical Association and was based on an analysis of previous clinical trials. Celebrex and Vioxx® are projected to produce U.S. sales greater than $6 billion this year.
In a study of more than 8,000 patients that compared the COX-2 inhibitor rofecoxib (Vioxx®) with the traditional NSAID naproxen, the risk of cardiovascular
problems, including heart attack, chest pain related to heart disease, stroke, sudden death and blood clots, was more than two times higher in the rofecoxib
group than in the naproxen group.
Vioxx® like Celebrex isclassified as and known as COX-2 inhibitors, or coxibs. COX-2 inhibitors, like older drugs such as ibuprofen and naproxen, are nonsteroidal anti-inflammatory drugs, or NSAIDs. Older NSAIDs reduce inflammation by blocking an enzyme called COX-2, but they also block another enzyme called COX-1. This enzyme helps protect the lining of the stomach, so blocking OX-2 can cause stomach irritation. COX-2 inhibitors only block COX-2, leaving the stomach-protecting COX-1 alone.
In 2000 Merck spent $160.8 million on direct to consumer Vioxx® marketing. Many people are familiar with Vioxx® television advertisements featuring the famous figure skater Dorothy Hamill. Sid Wolfe, a physician and director of the Health Research Group of the advocacy group Public Citizen in Washington, D.C. said "Dorothy Hamill doesn't tell people they have a four times higher risk of a heart attack on Vioxx®."
Vioxx® was removed from the market on September 30, 2004 after a study revealed that Vioxx® was linked to heart attacks, strokes, blood clots and cardiovascular injuries. The removal of Vioxx® from the market was a major surprise to many people but the first signs of problems with Vioxx® were first noticed over four years ago. In fact even before Vioxx® was approved by the FDA a University of Pennsylvania study raised questions about whether Vioxx® raised the risk of heart attacks and strokes.
Shortly after Vioxx® was approved and put on the market a study sponsored by Merck and published in the New England Journal of Medicine in 2000 clearly showed and increase in heart attacks. However many healthcare professionals ignored these studies and regularly prescribed Vioxx®. In 2001 Doctors at the Cleveland Clinic published a study in the Journal of American Medical Association JAMA re-analyzing existing data. This study again showed the risk of heart attacks and other serious side effects. Instead of acknowledging Vioxx®'s side effects Merck said it would conduct a big study testing Vioxx®'s heart safety, but the study never materialized.
By the time Vioxx® was removed from the market it had been used by millions of people worldwide and its annual sales in 2003 totaled $2.5 billion. Vioxx® growth was in a large part due to Merck's aggressive direct to consumer advertising. In 2000 Merck spent $160.8 million on direct to consumer Vioxx® marketing. Many people are familiar with Vioxx® television advertisements featuring the famous figure skater Dorothy Hamill. Sid Wolfe, a physician and director of the Health Research Group of the advocacy group Public Citizen in Washington, D.C. said "Dorothy Hamill doesn't tell people they have a four times higher risk of a heart attack on Vioxx®."
On September 30, 2004 Vioxx® was finally taken off the market. The withdrawal came after a Merck study that tried to show Vioxx® reduced Colorectalpolyps, instead showed again that Vioxx® increased the risk of heart attacks, strokes, blood clots and other cardiovascular injuries. The Attorneys at Parker & Waichman have been representing victims of Vioxx® side effects since the New England Journal of Medicine study was released. Parker & Waichman has extensive experience representing victims of Vioxx® and we continue to fight for the rights of people who have been injured by this drug.
Vioxx® Side Effects
Recently a report in the Journal of the American Medical Association linked Vioxx® to blood clots, heart attacks, and strokes.
Other serious side effects associated with Vioxx® usage are:
Serious stomach problems, such as stomach and intestinal bleeding, can occur with or without warning symptoms. These problems, if severe, could lead to hospitalization or death. Although this happens rarely, you should watch for signs that you may have this serious side effect and tell your doctor right away.
Serious allergic reactions including swelling of face, lips, tongue, and/or throat which may cause difficulty breathing or swallowing occur rarely but may require treatment right away.
Serious kidney problems occur rarely, including acute kidney failure and worsening of chronic kidney failure.
Severe liver problems occur rarely in patients taking NSAIDs. Tell your doctor if you develop symptoms of liver problems. These include nausea, tiredness, itching, tenderness in the right upper abdomen, and flu-like symptoms.
More common, non life threatening, side effects associated with Vioxx® have include:
Upper and/or lower respiratory infection and/or inflammation
Headache
Dizziness
Diarrhea
Nausea and/or vomiting
Heartburn, stomach pain and upset
Swelling of the legs and/or feet
High blood pressure
Back pain
Tiredness
Urinary tract infection.
If you or someone you know has a BEXTRA® related injury, you owe it to yourself to make sure that your rights are protected. Your rights vary depending on many factors such as your residence, age, and the frequency of BEXTRA® usage. Each state has its own laws and governs the law differently. Each state also has its own deadlines for allowing victims to file legal suits to protect their rights called statutes of limitation and statutes of repose.
Under the law, if you have BEXTRA® related injury , you are entitled to fair compensation from the companies that are responsible for the your personal injury or even the death of a loved one.
Eligibility
If you are a victim of a BEXTRA® related injury , your eligibility will depend on several factors:
a) Statute of Limitations
b) Identify Your Exposure
c) Responsible Parties
Wrongful Death Suit
The law also says that if you are a close family member of a person who died of a BEXTRA® related injury , you may also have the right to seek compensation for your loss. This right is called a "wrongful death" suit. The laws of different states vary as to which family members have the legal right to recover for the wrongful death of a family member. We can help decide which state is best for your case, depending upon your individual situation.
Statute of Limitations
While you have the right to sue if you have, or a family member has a BEXTRA® related injury , there is a time frame during which you must file your case. This statute of limitations varies from state to state, but if you wait too long, you will be barred from taking legal action. If you are interested in filing a case, it is important that you seek legal advice as soon as possible.