Vioxx Side Effects

Vioxx, a pain reliever for arthritis patients, was pulled from the market in 2004. The move came after a study linked the drug to an increased risk of serious cardiovascular problems, including heart attacks and strokes. Other serious side effects associated with Vioxx use included allergic reactions, and severe kidney and liver problems.

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Vioxx, a painkiller once commonly used for joint pain and arthritis, quickly became one of Merck’s best-selling drugs after its debut in 1999. The company voluntarily removed drug from all markets in 2004 amid concerns about cardiovascular risks, specifically heart attacks and strokes.

Other side effects included:

  • Blood clot
  • Serious allergic reactions, including anaphylaxis and edema (swelling)
  • Kidney impairment and/or kidney failure
  • Serious gastrointestinal issues, including stomach and intestinal bleeding

And severe liver problems, such as:

  • Jaundice (yellowing of the skin and whites of the eyes)
  • Hepatitis (inflammation of the liver)
  • Liver failure

Vioxx and Heart Attacks

Merck decided to pull Vioxx from the market based on data from a trial called APPROVe (Adenomatous Polyp Prevention on Vioxx). This study compared Vioxx to a placebo, or dummy pill, to determine if Vioxx taken at a dosage of 25 milligrams was effective in preventing the recurrence of colon polyps. However, the trial was stopped early when it was discovered that Vioxx led to an increased risk for serious cardiovascular events, such as heart attacks and strokes.

This increased risk of heart attack was initially determined to be linked to prolonged or chronic use of Vioxx, usually longer than 18 months. However, evidence published In a Canadian journal nearly two years after the drug’s worldwide market withdrawal suggests that may no longer be the case, and that cardiovascular risks associated with Vioxx may occur much sooner in the course of treatment than previously determined in the APPROVe trial.

Fact

Patients taking Vioxx may have suffered from a heart attack within just two weeks of starting treatment with the painkiller, according to one study.

While some reports estimated deaths resulting from heart attacks after Vioxx use to be in the tens of thousands, others argued it may have reached into the hundreds of thousands.

What Is a Heart Attack?

Each year, in the U.S., nearly 800,000 people experience a heart attack. This equates to one person suffering a heart attack about every 40 seconds, according to the American Heart Association (AHA). A heart attack, also called a myocardial infarction, is a serious condition affecting the heart muscle. The heart muscle needs oxygen to survive. When the flow of oxygen-rich blood is severely reduced or blocked, the heart cannot get oxygen and the heart muscle (and heart cells) begins to die. This impediment is most commonly due to a blood clot or narrowing in the coronary arteries.

One person in the U.S. suffers from a heart attack every 40 seconds.

Sometimes the terms heart attack and cardiac arrest are used interchangeably, but they are not the same condition. A heart attack is the result of a circulation problem, whereas sudden cardiac arrest is an electrical problem that causes the heart to suddenly stop beating. However, a heart attack can sometimes cause cardiac arrest.

In cardiac arrest, a person dies as a result of the heart suddenly not working properly. This is most often the result of arrhythmias, or abnormal or irregular heart rhythms. Death can occur within just minutes of the heart stopping. Cardiac arrest can sometimes be reversed, however, when CPR is performed and a defibrillator is used to shock the heart. This shock helps to restore the heart’s normal rhythm.

Causes and Risk Factors of Heart Attacks

Coronary artery disease
Coronary artery disease is the most common cause of a heart attack

The most common cause of a heart attack is coronary artery disease. It occurs when sticky substance called plaque builds up on the inner walls of the coronary arteries. This plaque is made up of cholesterol, fat, calcium and other substances. The accumulation of plaque hardens over time, a condition called atherosclerosis. Arteries narrow, reducing blood flow. Additionally, when the plaque breaks open or tears, a clot can form at the site of the rupture, blocking most or all of a vessel’s blood flow.

A severe spasm, or tightening, of a coronary artery, that cuts off blood flow, is a less common cause of a heart attack. Sometimes, the cause of a heart attack is unknown.

A heart attack can occur at any time in a person of any age, and even while a person is resting or asleep.

Some instances that might trigger a heart attack include:

  • After a sudden increase in physical activity
  • When a person is active outside in cold weather
  • After sudden, severe emotional or physical stress, including illness

There are also certain risk factors for heart disease leading to heart attacks. A risk factor increases a person’s chance of having a certain health condition. Some of these risk factors are unavoidable, while others can be modified.

Risk factors of a heart attack that cannot be changed include:

  • Increasing age, especially in people who are 65 or older – Also, women at older ages who have a heart attack are more likely than men to die from the heart attack within a few weeks
  • Gender – Men have a greater risk of having a heart attack than women (even after menopause when a woman’s risk increases), and the attacks can occur much earlier in life
  • Heredity, including race – Children of parents who have had heart attacks, and African Americans, Mexican Americans, American Indians, Hawaiians and some Asian Americans are all at an increased risk of heart disease and heart attacks

Risk factors that can be changed, treated or controlled include:

  • Smoking cigarettes – Cigarette smoking is also a risk factor for sudden cardiac death in patients with heart problems; a person’s risk of heart disease can be increased due to indirect exposure to cigarette smoke as well
  • High blood cholesterol – Low HDL cholesterol (good cholesterol) also puts a person at a higher risk for heart disease
  • High blood pressure – Increases the heart’s workload, resulting in thickened and stiffer heart muscle
  • Physical inactivity – Physical activity can help control blood cholesterol, diabetes and obesity, as well as help lower blood pressure in some people
  • Obesity and overweight – Excess body weight, especially around the waist, increases a person’s risk of developing heart disease and stroke even if no other risk factors are present
  • Diabetes mellitus – Diabetes significantly increases a person’s risk for heart problems, even when glucose levels are under control, but especially when they’re not

Signs and Symptoms of a Heart Attack

A heart attack can begin slowly and gradually intensify, or it can begin suddenly and come on strong without warning. When a person has a heart attack without any symptoms, it is called a silent heart attack. More often, however, a person will experience signs and symptoms of a heart attack, or impending heart attack, that will signal them to get necessary emergency medical attention.

image of man holding his chest
Chest pain or discomfort is the most common symptom of a heart attack

Warning signs of a heart attack may differ slightly for men and women, although the most common symptom, chest pain or discomfort, is typically experienced by all patients who suffer from the emergency heart condition. The pain or unusual feeling begins in the center of the chest and can radiate throughout the upper body and in one or both arms.

Chest discomfort experienced by people having a heart attack can feel like pressure, squeezing, fullness or pain that lasts for more than a few minutes, often longer than 20 minutes, or that goes away and comes back. Chest pain can be mild or severe.

Diagnosis and Treatment of a Heart Attack

A physical exam may be performed to listen to the chest using a special medical instrument called a stethoscope. This exam can help a patient’s doctor hear abnormal sounds in the heart (heart murmurs) and lungs (crackles), as well as check for a fast or uneven pulse (arrhythmias), or determine if the patient’s blood pressure is normal, high or low.

Other tests that can be performed to check for heart damage or look at the heart, include:

  • Electrocardiogram (ECG) – to look for heart damage; can also sometimes show if a patient is having a heart attack
  • Blood test – to show if a patient has heart tissue damage; can confirm a heart attack
  • Coronary angiography – can be done right away or after the patient is stabilized; this test can help a doctor determine a course of treatment
  • Echocardiography – with or without stress testing
  • Exercise stress test – measures the effect of exercise, or activity, on the heart
  • Nuclear stress test – uses a nuclear imaging method to show how well blood flows into the heart muscle at rest and during activity
  • Heart CT scan or heart MRI

Other Vioxx Side Effects

Vioxx was associated with other serious side effects not directly affecting the heart, including:

  • Increased blood pressure
  • Increased risk of kidney problems, including acute kidney failure
  • Severe liver problems, including liver failure
  • Edema, or swelling

The development of blood clots associated with Vioxx also resulted in stroke in some patients. Based on 108,076 people who reported side effects to the FDA, 24,318 patients (or 22.5 percent of those who reported side effects) suffered a stroke after taking Vioxx.

The majority of those affected were women and had been taking Vioxx for two to five years. Stroke as a side effect of Vioxx also mostly affected those 60 or older who took the drug to treat joint pain or osteoarthritis.

Stroke is the fifth leading cause of death in the U.S. affecting about 795,000 Americans each year, according to the Centers for Disease Control and Prevention. Although treatable, stroke is also a major cause of serious, and permanent, disability in adults.

A stroke occurs when blood flow, and thereby oxygen, is blocked to the brain. Without oxygen, the brain’s cells begin to die within just minutes. Hemorrhage, or sudden bleeding in the brain, can also cause a stroke if it results in damage to brain cells.

Signs and symptoms of a stroke include:

  • Sudden weakness
  • Paralysis (inability to move) or numbness of the face, arms or legs
  • Trouble speaking or understanding speech
  • Trouble seeing (vision impairment)

A stroke requires emergency medical care. In some cases, a stroke can lead to permanent brain damage or death.

Please seek the advice of a medical professional before making health care decisions.

Author

Kristin Compton is a medical writer with a background in legal studies. She has experience working in law firms as a paralegal and legal writer. She also has worked in journalism and marketing. She’s published numerous articles in a northwest Florida-based newspaper and lifestyle/entertainment magazine, as well as worked as a ghost writer on blog posts published online by a Central Florida law firm in the health law niche. As a patient herself, and an advocate, Kristin is passionate about “being a voice” for others.


Hide Sources

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