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60 Minutes In Depth Reporting Reveals:
Nov. 14, 2004

"(CBS) When the pharmaceutical giant Merck pulled its blockbuster pain medication Vioxx off the market in late September, it became the largest prescription drug recall in history.

The company says it took immediate action after a new study showed that Vioxx doubled the risk of heart attacks and strokes in some patients.
 
However, according to internal Merck documents 60 Minutes has seen, and interviews with outside scientists, Merck had concerns that Vioxx could possibly cause cardiovascular risks long before it was pulled off the market.

Some 20 million Americans took Vioxx in the five-and-a-half years it was being sold. It may have contributed to thousands of heart attacks and sudden deaths. Three government investigations are now underway to determine just how and why Vioxx became a prescription for trouble. Correspondent Ed Bradley reports.

When Vioxx first hit the market under a barrage of TV commercials, it was hailed by Merck as a miracle drug.

It was one of a new class of drugs called COX-2 inhibitors that could reduce all kinds of pain, especially arthritis, without causing serious gastrointestinal discomfort and bleeding - a risk seen in older drugs like aspirin, Aleve and Advil.

With annual sales of about $2.5 billion, Vioxx was one of the most successful new drugs ever. It was prescribed to people like 39-year-old Janet Huggins, who had been diagnosed with early stage rheumatoid arthritis.

According to her medical records, Huggins was in otherwise excellent health. But that was until Sept. 25, when she died of a sudden heart attack - less than a month after she started taking Vioxx. She was buried on the very day Merck took Vioxx off the market. Huggins' husband Monty is suing Merck, holding the company responsible for her death.

"The morning of her funeral, I had just gotten dressed and my sister walked in and told me that she had just seen on the news that Vioxx had been pulled from the market. And when she told me that, I can't explain what hit me," says Monty Huggins. "I dropped straight to the floor. It was just a shock, because this is a 39-year-old female that's in good shape and is healthy and she's got a heart attack."

He says that if the drug had been taken off the market a month earlier, "I believe my wife would be here."

But was it Vioxx? Merck says it believes that many of the deaths being attributed to Vioxx could be explained by any number of other causes. The company insists it has acted responsibly, saying it withdrew Vioxx as soon as it received what it says was surprising data from a clinical trial it was conducting, called the APPROVe (Adenomatous Polyp Prevention on VIOXX) study, designed to determine if Vioxx could prevent colon polyps.

Instead, Merck found something potentially worse: Patients taking Vioxx for longer than 18 months were twice as likely to suffer a heart attack or stroke than those taking a placebo.

Merck declined a request from 60 Minutes for an on-camera interview, but CEO Raymond Gilmartin explained the company's decision in a Sept. 30 news conference..."

Click To Read the full 60 Minutes Transcript >


Vioxx FAQs

» What is Vioxx?
» Why did Merck take Vioxx off the market?
» How can an arthritis drug lead to heart attack and stroke?
» What are the side effects of Vioxx?
» What does this mean for Celebrex or Bextra, the other two drugs in the class known as COX-2 inhibitors?
» What can I take instead of Vioxx or Celebrex?
» What should I do if I am currently taking Vioxx?
» What should I do if I have been a victim of prescription drugs?
» If I file suit against the manufacture of Vioxx, what are my chances of winning?
» How common is pharmaceutical / prescription negligence?

What is Vioxx?

Vioxx is a popular anti-inflammatory medication introduced to the U.S. market in 1999, and used to be prescribed to ease the pain, swelling and other symptoms of osteoarthritis. Before drugmaker Merck & Co. withdrew it from the worldwide market September 30, 2004, it was most commonly given to patients with Osteoarthritis. Vioxx belongs to a class of medications known as cyclooxygenase-2, or COX-2, inhibitors. Sales topped $2.55 billion in 2003.

Vioxx – a non-steroidal, anti-inflammatory drug (NSAID) – is in a class of drugs commonly referred to as "Cox-2 Inhibitors". It comes in liquid or pill form, and is prescribed to relieve the symptoms of osteoarthritis. It can also be used to treat acute pain in adults such as those patients who experience severe pain associated with menstruation. Vioxx works by blocking COX-2 enzymes in the body that trigger pain and inflammation.


Why did Merck take Vioxx off the market?
Merck pulled its best-selling arthritis drug off the market based on data indicating the drug increases the risk of heart attack and stroke among users.

Merck announced the immediate, voluntary worldwide withdrawal after a three-year colon cancer clinical trial with 2,600 patients revealed that 18 months after patients started taking Vioxx, test results showed an increased risk of heart attacks and other cardiovascular complications.
84 million people have used Vioxx since 1999.

In previous years, Merck consistently denied any possible links between Vioxx and cardiovascular problems.

The drug was licensed in June 1999. Since then, more than 20 million Americans have taken the drug at one time or another. In September 2001, the FDA sent Merck an eight-page warning letter about the company’s promotional campaign for Vioxx. The letter indicated that the campaign minimized “the potentially serious cardiovascular findings that were observed” in a trial that compared the drug to naproxen, a less-expensive painkiller. The FDA charged that Merck discounted the fact that "patients on Vioxx were observed to have a four to five-fold increase" in heart attacks, compared with patients on naproxen.


How can an arthritis drug lead to heart attack and stroke?
Scientists say they are not sure. However, several studies have indicated that Vioxx and other COX-2 inhibitors are known to raise blood pressure and increase the risk of heart attack. Drugs such as Vioxx and Pfizer's Celebrex inhibit Cox-2, an enzyme that triggers pain and inflammation.

Vioxx has also been associated with several other life-threatening side effects, including blood clots, angina and nonbacterial meningitis, severe intestinal damage, ulcerations and bleeding, and kidney damage.


What are the side effects of Vioxx?
Vioxx side effects may include, but are not limited to, heartburn, nausea, diarrhea, upper respiratory tract infection, swelling of the lower extremities (legs and/or feet), high blood pressure, itching, stomach ulcers or bleeding, fatigue, vomiting, dark urine, and black stools.

In addition to increasing risk of heart attack and stroke, patients taking Vioxx were found to be four times more likely to suffer from heart attack than those taking Naproxen (Aleve). Vioxx is more likely to cause severe intestinal damage, ulcerations and bleeding, blood clots and toxic epidermal necrolysis (a fatal skin disease), than other arthritis pain relievers.

Other health problems include:

  • Serious kidney problems that could lead to acute kidney failure.
  • Serious liver problems.
  • Allergic reactions, such as swelling of the face, lips, tongue, and throat which can cause difficulty breathing or swallowing.
  • The FDA reports that Vioxx has also been linked to at least five cases of a non-bacterial type of meningitis, a rare but serious side effect.

These conditions may come about suddenly with few or no symptoms. If left untreated, hospitalization or even death can occur.

If you, or a loved one, have taken Vioxx and experienced any side effects, contact our pharmaceutical negligence lawyers today, for a free evaluation - 1.800.536.HELP


What does this mean for Celebrex or Bextra, the other two drugs in the class known as COX-2 inhibitors?
In light of the Vioxx study findings, several top scientists have stated that the finding of an elevated risk of heart attacks and strokes applies to all COX-2 inhibitors. Clinical trials of Celebrex and Bextra did not reveal the same problems as Vioxx because participants were allowed to take aspirin, which has proved to reduce the risk of cardiovascular problems.

Pfizer, maker of Celebrex and the less-prescribed Bextra, stands by its products. But studies are continuing to review the link of these drugs to cardiac problems.

More About Vioxx & Celebrex >


What can I take instead of Vioxx or Celebrex?
Older medications like ibuprofen, naproxen or simply aspirin have been used as alternatives for Vioxx and Celebrex.


What should I do if I am currently taking Vioxx?
Contact your doctor to discuss discontinuing use of Vioxx and possible alternative medications. If you have experienced any side effects, contact a lawyer to review your case. We understand your medical concerns take priority, but don't ignore your legal right to compensation.

Your state's law may limit your time to bring a legal claim. To protect your rights, you need to have your personal injury claim evaluated immediately.

Free Vioxx Case Evaluation >


What should I do if I have been a victim of prescription drugs / pharmaceutical negligence?
You may be experiencing pain and suffering and severe financial hardships. You should not go through this difficult time alone. You, the patient, should not be paying for your doctor's mistakes or negligence.

If you or a loved one are living with the consequences of the effects from Vioxx, it is important to contact an experienced lawyer who can protect your rights and get you the compensation to which you are entitled.

Our Vioxx Lawyers have a track record of success representing your rights against drug manufacturers. We are available to discuss your potential claim, and answer any questions you might have. Call us for a Free Case Evaluation : 1.800.536.HELP


If I file suit against the manufacture of Vioxx, what are my chances of winning?
Every case is different; however, patients who were prescribed Vioxx and experienced serious health conditions (such as a heart attack, stroke, or kidney failure) because of it have an excellent chance to recover monetary compensation for the losses that they have incurred.

There is evidence that suggests Merck knew of the health risks associated with Vioxx, but continued to heavily market the arthritis drug. Brown & Crouppen litigates your case against the giant drug manufacturers. Have your claim evaluated today, click here.


How common is pharmaceutical / prescription negligence?
Prescription drug side effects, or Adverse Drug Events (ADE’s) result in more than 550,000 injuries and over 100,000 deaths each year, according to the Journal of the American Medical Association.
Nearly one out of every five medication doses given in hospitals and nursing facilities is improperly dispensed or prescribed. More than 40 potentially harmful drug errors occur, on average, in hospitals on a daily basis. (Archives of Internal Medicine).

In pediatric emergency rooms, according to statistics, doctors misprescribe 4 in every 1,000 prescriptions written. (presented at the American Academy of Pediatrics conference).
Unfortunately, pharmaceutical negligence/malpractice, by doctors and pharmacists, is too common. The prescription drugs and victims of these medications are widespread.

If you feel that you, or someone you love, has been injured by prescription/pharmaceutical negligence, please contact us for a free evaluation.


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