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AndroGel Pulmonary Embolism Lawsuit

On June 19, 2014, the U.S. Food & Drug Administration (FDA) issued a warning which stated that prescription testosterone supplements including AndroGel will have their labeling updated to include information about the risk of blood clots, which are a known risk factor for pulmonary embolism, deep vein thrombosis and venous thromboembolism (VTE).

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If you or a loved one developed a pulmonary embolism after using AndroGel, you should contact our law firm immediately.

You may be entitled to compensation by filing an AndroGel Pulmonary Embolism lawsuit and we can help. Please click the button below for a Free Confidential Case Evaluation or call us toll-free 24 hrs/day by dialing (866) 588-0600.

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Testosterone Replacement Therapy (TRT) Linked to Cardiac Risks

The testosterone supplement industry has grown by leaps and bounds in recent years. In commercials and internet campaigns, middle aged men are being told that low testosterone levels may be the cause of their physical and emotional problems.

Questioning one’s manhood has become a strategic marketing gimmick, with billions of dollars in profits to show for it. But while taking TRT products like AndroGel may restore your lost masculinity, new research indicates it may come at the expense of your health.

A study published in the November 2013 edition of the Journal of the American Medical Association (JAMA) indicated that testosterone treatment was linked to an increased risk of cardiac complications like:

  • Stroke
  • Heart attack
  • Arrhythmias
  • Coronary artery disease
  • Transient ischemic attacks
  • Pulmonary embolism

Unfortunately, some men in the study died as a result of their complications after using AndroGel. “… the use of testosterone therapy was associated with increased risk of adverse outcomes,” the researchers said. “These findings may inform the discussion about the potential risks of testosterone therapy.”

What is a Pulmonary Embolism?

A pulmonary embolism refers to a blockage in 1 or more arteries of the lungs. In most cases, pulmonary embolisms occur when blood clots travel to the lungs from another part of the body. A common situation is where a clot in the leg, called a deep vein thrombosis, becomes trapped in the lung, which results in a pulmonary embolism.

Symptoms of Pulmonary Embolism

Signs and symptoms of a pulmonary embolism may include:

  • Sudden shortness of breath
  • Sharp chest pain that gets worse when coughing or taking a deep breath
  • Cough that produces pink, foamy mucus
  • Anxious feeling
  • Excessive sweating
  • Light-headedness
  • Heart palpitations

How Can AndroGel Cause a Pulmonary Embolism?

The new warning comes as the FDA continues to investigate the link between testosterone and cardiovascular side effects, following studies (cited above) that identified links between the supplements and heart attacks, strokes and sudden death.

Testosterone boosters had previously been linked to an increased risk of blood clots due to polycythemia, a condition characterized by an abnormal increase in red blood cell count. However, the FDA has received new reports of testosterone blood clots that are not associated with polycythemia. The new label changes updated the existing blood clot warning from one linking the side effect to polycythemia, to a more generalized venous thromboembolism warning.

Prognosis (Outlook)

Although fatality rates have dropped significantly in recent years, acute pulmonary embolism continues to pose a serious public health threat. Prompt recognition and diagnosis of the condition are critical to ensure the highest quality of care. High risk pulmonary embolism patients are likely to require immediate thrombolytic, surgical, or interventional reperfusion therapy.

Much progress has been made in the field of anticoagulation therapy, with the emergence of treatment with vitamin K antagonists and the encouraging results of trials using oral anticoagulant medications. New management strategies have simplified secondary prevention and helped to resolve controversy over the optimal duration of anticoagulation treatment after acute pulmonary embolism.

Treatment

Pulmonary embolisms can be treated with prescription drugs, surgery and other therapies. The primary goal of treating pulmonary embolism is to stop the blood clot from growing and to keep new clots from developing. Treatments include drugs to thin the blood and slow its clotting mechanisms. If symptoms are deemed to be life-threatening, the doctor may administer medications to dissolve the clot. In rare cases, surgery or another operation may be recommended to remove the blood clot.

Medications

Anticoagulant medications can decrease the blood’s ability to clot. Anticoagulants are administered to stop existing blood clots from growing, and to prevent future clots from forming. However, these drugs are not able to break up blood clots that have already developed.

Blood thinners can be taken as either a pill, injection, or intravenously (IV). Warfarin is given as a pill, while heparin is administered as an injection or through an IV tube. Pulmonary embolism patients may be treated with both heparin and warfarin simultaneously. Heparin acts rapidly, while warfarin takes an average of two to three days to work. Once warfarin starts to be effective, heparin usually is discontinued.

If you have deep vein thrombosis, anticoagulant treatment usually lasts for between three and six months. If the patient has had previous blood clots, extended treatment may be necessary. If the patient is being treated for another disease like cancer, you may need to take anticoagulants as long as pulmonary embolism risk factors are present.

Emergency Treatments

When pulmonary embolism is life threatening, treatments may be ordered to remove or break up the blood clot. These are typically administered in an emergency room or hospital setting. Thrombolytics are prescription drugs that can dissolve a blood clot. In most cases, they’re used for the treatment of large clots that cause severe symptoms. Because thrombolytics can cause sudden bleeding, they’re used only in potentially fatal medical emergencies. Sometimes catheters may be used to reach blood clots. The catheter is inserted into a vein in the groin or arm and guided to the lung. The doctor may use the catheter to remove the clot or deliver clot busters to dissolve it.

Diagnosis

A diagnosis of pulmonary embolism can be made based on the patient’s medical history, physical exam and test results. In most cases, emergency room doctors and radiologists confirm the diagnosis.

Medical History / Physical Exam – To diagnose pulmonary embolism, the doctor will inquire about the patient’s medical history. They will:

  • Determine deep vein thrombosis (DVT) risk factors
  • See how likely it is that the patient may have a pulmonary embolism
  • Rule out other potential causes of symptoms

The doctor also will perform a physical examination. During this exam, they will assess the patient’s legs for signs of deep vein thrombosis. The doctor will also check their blood pressure, heart and lungs.

Diagnostic Tests

A number of tests can be ordered to help diagnose pulmonary embolism. Which tests the patient gets depends on how they reach the hospital, their risk factors and testing options. One or more of the following tests may be performed:

  • Ultrasound – Uses sound waves to identify blood clots in the legs and check blood flow in the veins. During an ultrasound, gel is placed on the legs and a hand-held transducer is moved over the affected areas. The transducer produces waves and detects their echoes as they bounce off veins and blood cells. The echoes appear as a picture on a computer screen, allowing the doctor to see blood flow in the patient’s legs. If the doctor finds blood clots in the legs, treatment will likely be recommended.
  • Computed Tomography (CT) Scan – Used to look for blood clots in the lungs and legs. For this test, dye is injected into a vein in the arm which makes the blood vessels in the lungs and legs appear as x-ray images. The patient lies on a table, and an x-ray rotates around them. The tube takes pictures from multiple angles. CT scans allow doctors to detect most pulmonary embolisms.
  • Lung Ventilation/Perfusion Scan (VQ Scan) – Uses a radioactive substance to determine how well oxygen and blood are flowing to the lungs. VQ scans can help to diagnose many cases of pulmonary embolism.
  • Pulmonary Angiography – For this test, a catheter is threaded through the groin or arm to the blood vessels in the lungs. Dye is injected into the blood vessels and x-ray pictures are taken to show blood flowing through the lungs. If a blood clot is identified, the catheter may be used to remove it or deliver clot-buster medications to dissolve it.
  • Blood Tests – Measure substances in the blood that are released when a clot dissolves. High levels of these substances may indicate that a blood clot is present. If the patient’s test is normal and he or she has few risk factors, pulmonary embolism isn’t likely. Other blood tests are used to diagnose inherited disorders that cause blood clots.

How To Prevent a Pulmonary Embolism

If you are an AndroGel user, one of the most important things you can do to prevent a pulmonary embolism is to quit taking testosterone now. However, never discontinue treatment with a prescription medication without talking to your doctor first. Pulmonary embolism prevention begins with preventing deep vein thrombosis.

If you already have had a deep vein thrombosis or pulmonary embolism, you can prevent additional clots from developing in the future by:

  • Getting regular medical checkups
  • Taking prescription drugs to prevent future blood clots
  • Using compression stockings to prevent swelling in your legs after deep vein thrombosis
  • Calling your doctor right away if you have any symptoms of a pulmonary embolism

Do I Have an AndroGel Pulmonary Embolism Lawsuit?

The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in AndroGel Lawsuits. We are handling individual litigation nationwide and currently accepting new pulmonary embolism cases in all 50 states.

If you or a loved one suffered a pulmonary embolism after taking AndroGel, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.

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