Testosterone Pulmonary Embolism
Men who use AndroGel and other prescription testosterone treatments may be in danger of experiencing a serious blood clot, including pulmonary embolism. Since January 2014, the U.S. Food & Drug Administration (FDA) has issued several warnings regarding the cardiovascular side effects potentially associated with Low-T therapy.
Testosterone Lawsuit Reviews
Thousands of men have filed testosterone lawsuits in order to obtain compensation for heart attacks, stroke, blood clots, and other cardiovascular complications allegedly associated with the use of low-T therapy. If you would like to learn more about the compensation that could be available to men who allegedly suffered a testosterone-related pulmonary embolism, please call (888) 994-5118 to arrange for a free, no-obligation case review with the legal team at Bernstein Liebhard LLP.
Low-T Therapy
Prescription testosterone medications are approved to treat men who suffer from hypogonadism, or low testosterone, that results from another underlying illness or medical condition. However, the use of such products has spiked sharply since they were first launched on the market, driven by advertising that some say positions the medications as a way to combat the effects of male aging.
Low testosterone therapy medications currently approved by the FDA include:
Testosterone Heart Review
On January 31, 2014, the FDA announced it was reviewing the safety of these drugs, after two studies indicated they could increase cardiovascular risks in certain men:
- November 2013: A JAMA study suggested that low testosterone therapy increased the risk of heart attack, stroke and death among older men with pre-existing heart problems.
- January 2014: Research published in PLOS One, reported that such treatments were associated with a doubling of the heart attack risk among younger men with pre-existing heart problems, and in men over 65 regardless of their heart health.
The FDA would complete its review its review in March 2015, and order all low-T manufacturers to include heart attack and stroke warnings on their product labels. The agency also mandated that the labels clearly state that the drugs haven’t been shown to be safe or effective in treating age-related hypogonadism. Read More
Testosterone Blood Clot Warning
In June 2014, the FDA announced that the labeling for prescription testosterone medications would be updated to include information about their association with venous blood clots, including pulmonary embolism. The agency did note that the prescribing information for low testosterone therapies already includes notice of a risk of venous blood clots that are associated with the development of a condition called polycythemia. However, the FDA was requiring the manufacturers to modify the labels with a more general warning in light of reports of testosterone patients who experienced blood clots in the absence of this condition. Read More
What is a Pulmonary Embolism?
A pulmonary embolism is a blood clot that forms deep in the veins of the leg and travels to the lung, where it blocks the pulmonary artery. Symptoms of pulmonary emboli include:
- Shortness of breath
- Chest pain
- Cough (may be bloody or blood streaked)
- Pain and swelling in one or both legs, often the calf
- Cyanosis (clammy, discolored skin)
- Rapid or irregular heartbeat
- Lightheadedness or dizziness
These types of blood clots are always life-threatening, and require immediate medical treatment.
Are You Eligible to File a Testosterone Lawsuit for Pulmonary Embolism?
There is still time for the alleged victims of testosterone-related pulmonary embolism to file their own lawsuits against the manufacturers of low-T therapies. To learn more about this growing litigation, please contact our attorneys today, by calling (888) 994-5118.
- New York Times, February 2014. “Overselling Testosterone, Dangerously.” http://www.nytimes.com/2014/02/05/opinion/overselling-testosterone-dangerously.html?_r=0
- FDA, January 2014. “FDA Evaluating Risk of Stroke, Heart Attack and Death with FDA- Approved Testosterone Products.” http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm
- FDA (2015) “FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use” http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm
- FDA, June 2014. “FDA Adding General Warning to Testosterone Products About Potential Venous Blood Clots” http://www.fda.gov/drugs/drugsafety/ucm401746.htm
- MayoClinic, January 2014. “Pulmonary Embolism.” http://www.mayoclinic.org/diseases-conditions/pulmonary-embolism/basics/symptoms/con-20022849
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