Testosterone Replacement Therapy Injury Lawsuits - Cincinnati, Ohio
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Testosterone Replacement Therapy Lawyer

Cincinnati, Ohio product liability lawyer reviews Testosterone Replacement Therapy Side Effects: Patients report heart attacks and blood clots following Low T Therapy. 

On Wednesday, September 17th, 2014, a panel for the Food and Drug Administration (FDA) publicly advised that the FDA make stricter guidelines for the prescribing of testosterone supplements.  Sales of testosterone supplements increased 65% over the past four years[1].

Indeed, since 2000, the use of testosterone has quadrupled.[2]  The reason behind the spike has been attributed to the new “Low-T” phenomenon, in which patients are prescribed testosterone supplements merely due to low energy and reduced libido rather than the approved indications for testosterone replacement. [3]

Reuters, the New York Times, and the Wall Street Journal have all covered this ongoing debate. While the scientific community agrees more studies are needed, the consensus in the medical community is to make prescription testosterone more restrictive.

Testosterone Therapy has been over prescribed for aging purposes, when the intention of the drug was initially to assist men who experience low testosterone as a result of diseases, tumors, or post-chemotherapy.

Public Citizen recently contacted the FDA in hopes of getting a black box warning (the highest level warning issued by the FDA) on all testosterone supplement labels, regarding the cardiovascular risks associated with testosterone intake.

However, the FDA has currently denied the claim under the notion that there does not yet exist enough evidence supporting the adverse cardiovascular risks of testosterone drugs. Even so, lawyers are investigating heart attacks and pulmonary embolism reports following testosterone replacement therapy.

Types of Testosterone Therapy Drugs

Popular testosterone drugs include:

  • AbbVie Inc’s AndroGel
  • Auxilium Pharmaceuticals Inc’s Testim
  • Eli Lilly & Co’s Axiron

Testosterone Replacement Safety

Several testosterone supplement producers, such as AbbVie Inc. and Eli Lilly & Co., have made statements regarding how they do not condone the use of their drugs for purposes other than what is on their labels.  In general, the uses outlined on such labels are in reference to men with low testosterone due to certain diseases or recent chemotherapy.[4]

However, many advocates of the reduction in testosterone supplement usage argue that the language on the labels is not clear enough and can lead doctors to believe the drugs are suitable for patients simply experiencing “Low-T” symptoms.[5]

Notably, approximately one out of four men prescribed testosterone have not even had a test to determine their testosterone level before taking the drug, thus providing another reason to conclude that the drugs are often being prescribed in the wrong contexts.

Testosterone Replacement Linked to Heart Attacks

The FDA Advisory panel is advocating for such action due to various results regarding the effects of testosterone drugs.  In November 2013, the Journal of American Medical Association found that there was a 30% increase in heart attacks, strokes, and death for men taking testosterone, versus those who are not.[6]

However, the panel also decided to require further testing to be done regarding the effects of testosterone on heart attacks, blood clots, strokes, and death; this decision was made primarily on the face that the panel members were together “inconclusive” on whether or not the testosterone drugs directly cause heart problems, specifically. [7]

Is Testosterone Therapy Safe?

The Lyon Firm is reviewing Low T clinic injury and testosterone replacement therapy cases when a patient suffers a heart attack, venous thromboembolism (VTE) or pulmonary embolism. Plaintiffs are encouraged to speak to an experienced Ohio Low T Attorney to examine your legal options.

There are a number of ongoing observational and retrospective cohort studies related to the safety of testosterone replacement therapy. However, the only way to truly understand the risk is to perform a controlled clinical trial such as the Women’s Health Initiative. While the FDA has encouraged the manufactures to design such a study, there is no indication when or if such a powered study will take place.

Joe Lyon is a Cincinnati Catastrophic injury and product liability lawyer. If you or a family member have suffered a heart attack, stroke, blood clot, or death following testosterone replacement therapy, and you have questions on improving your quality of life or medical care, please call The Lyon Firm to discuss the potential legal remedies. You will speak directly with Mr. Lyon, and he will help you answer those critical questions.

For more information on the testosterone issue please see: http://news.yahoo.com/fda-panel-backs-limiting-testosterone-replacement-drugs-210117241–finance.html

[2] Tavernise, Sabrina. “F.D.A. Panel Backs Limits on Testosterone Drugs.” The New York Times. .

[3] Id.

[4] Supra note 1.

[5] Perrone, Matthew. “Experts Want Restrictions on Testosterone Drug Use.” The San-Diego Union Tribune. http://www.utsandiego.com/news/2014/sep/17/experts-want-restrictions-on-testosterone-drug-use/.

[6] Id.

[7] Gilblom, Kelly. “Testosterone Drugs May Need Further Study on Heart Risk.” Bloomberg. http://www.bloomberg.com/news/2014-09-17/testosterone-drugs-may-need-further-study-on-heart-risk.html.

[8] Supra note 5.

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