Low T and Testosterone Therapy Drugs

AndroGel and other popular drugs prescribed for testosterone replacement therapy (TRT) have been heavily marketed to treat low testosterone, or “Low T,” levels in men. Multiple studies have, however, found use of the prescription drugs can increase risk of potentially serious and life-threatening cardiovascular problems.
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The U.S. Food and Drug Administration (FDA) has approved testosterone drugs as a replacement therapy only for men who have low testosterone levels due to testicular, pituitary gland, or brain disorders causing a condition called hypogonadism. The FDA has cautioned against using the drugs for conditions related to aging, noting the efficacy and safety of testosterone administered for symptoms related to aging has not been established.

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FDA-approved testosterone treatments include topical gels, transdermal patches, injections, and applications to the upper gum or inner cheek (buccal application).

If you have suffered a heart attack, stroke, venous thromboembolic event such as deep vein thrombosis (DVT) or pulmonary embolism (PE), or a loved one has died after using a testosterone replacement therapy drug, you may be entitled to compensation for medical treatment or other costs.

Weitz & Luxenberg can help you learn more about your options with a free consultation.
Consult your doctor before stopping any prescribed medication.

AndroGel and the Popularity of Low T Drugs

One of the Low T drugs on the market is AndroGel, which generated $694 million in annual revenue in the U.S. in 2015 for AbbVie, its manufacturer. Annual revenue in the U.S. was $934 million in 2014 and over $1 billion in 2013.

Some brand-name TRT drugs include:

  • Androderm
  • AndroGel
  • Axiron
  • Foresta
  • Striant
  • Testim

The market for TRT drugs skyrocketed in the 2000s, with a 500% increase in prescriptions to 5.3 million and a $1.6 billion market occurring between 2000 and 2011.

Testosterone Drugs Linked to Complications

As the popularity of testosterone treatments grew, so did regulatory scrutiny.

By 2016, the FDA issued a statement of its decision to add class-wide labeling changes for all testosterone products, “adding a new Warning and updating the Abuse and Dependence section” discussing the possibility of complications from abuse of and dependence on testosterone treatments or other anabolic androgenic steroids that included:

  • Heart attack
  • Heart failure
  • Stroke
  • Depression
  • Hostility
  • Aggression
  • Liver toxicity
  • Male infertility

“Individuals abusing high doses of testosterone have also reported withdrawal symptoms, such as depression, fatigue, irritability, loss of appetite, decreased libido, and insomnia,” the FDA said.

If you or a family member suffered a heart attack, stroke, DVT, or PE after being prescribed AndroGel, Axiron, or another TRT drug, you may be entitled to compensation.

Discussing your case with an experienced attorney like those with Weitz & Luxenberg’s Defective Drugs and Devices Unit could help you understand your legal options.

Low T Drugs Overprescribed

The growth in TRT prescriptions, sales, and profits coincided with aggressive marketing and ad campaigns. The industry spent $107 million to advertise top brands in 2012. AndroGel manufacturer AbbVie spent more than $45 million in the first six months of 2013 alone on promotion for AndroGel.

One such ad campaign promoted AndroGel for treating typical signs of aging such as fatigue, lower sex drive, and changes in mood, though none of those are among the FDA’s approved indications.

“None of the testosterone products have indications for weight loss, increasing energy or improving mood,” Andrea Fischer, an FDA spokeswoman, told The New York Times in 2013. In addition, a review published in 2013 examining prescribing of testosterone drugs found that more than a quarter of prescriptions were for men who had not even had a test to determine their testosterone levels in the preceding year.

If you or a family member took a TRT drug and later suffered a heart attack, stroke, DVT, or PE, Weitz & Luxenberg would like to talk to you.

You may be entitled to compensation for medical expenses and other costs related to your injuries.

Low T Users Can Face Serious Health Complications

Researchers halted a study in 2009 after a data and safety monitoring board recommended doing so after noting significantly higher adverse cardiovascular events in patients taking testosterone gel.

The researchers published their findings in The New England Journal of Medicine in 2010, saying patients who took testosterone drugs were significantly more likely to experience one or more adverse events, and nearly five times as many men experienced cardiovascular-related events when compared to men given placebo.

A 2013 study published in the Journal of the America Medical Association looked at male veterans who had undergone cardiovascular assessment via coronary angiography and had testosterone levels lower than 300 ng/dL. The study found a nearly 30% increase in the risk of adverse outcomes, including heart attack, stroke, or death in those given testosterone supplementation.

A 2014 study published in the journal PLOS One found that the risk of heart attack was more than doubled in the 90 days after starting TRT drugs in men 65 or older. For men under 65 who had previously been diagnosed with heart disease before starting testosterone, the risk of heart attack was significantly increased, almost threefold.

“Patients and their physicians should discuss the risk of heart attacks when considering testosterone therapy,” Sander Greenland, a professor of epidemiology at the UCLA Fielding School of Public Health and one of the study’s authors, told NBC News.

In 2016, research published in the British Medical Journal found the risk of suffering a venous thromboembolism within the first six months of commencing testosterone to be statistically significantly 63% higher in men taking testosterone when compared to those who had never used it, based on UK hospital discharge data.

Patients Can Suffer Severe Complications

Some men have reported rapid declines in quality of life shortly after taking prescribed testosterone drugs.

A week after Steve Schabel was taking prescription testosterone in 2013 with hopes of improving his sex drive and treating his depression, he was hospitalized for breathing trouble. The Indiana man was diagnosed with a double pulmonary embolism. Blood clots had blocked veins in his lungs, nearly killing him.

“I thought for sure I was dying,” Schabel told the Chicago Tribune. “It was the scariest moment of my life.”

Jeff Goehring of Waukesha, Wisconsin was prescribed AndroGel in 2009 for low testosterone levels after he complained of persistent fatigue. Four days later, he collapsed from a stroke.  “It just ruined my life,” Goehring told the Milwaukee Wisconsin Journal Sentinel. “It took the best part of my life away.”

If you or a member of your family took a drug to treat Low T and then suffered a heart attack, stroke, sudden cardiac death, DVT, or PE, you could be entitled to compensation to cover medical bills and other related costs.

Weitz & Luxenberg can help you understand your options, beginning with a free consultation.

Warnings over Testosterone Drugs Mount

In January 2014, the FDA announced that it was “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.”

Just over a year later, in March 2015, the FDA required prescription testosterone manufacturers to warn patients of potential heart attack and stroke risks. The agency also cautioned the public that “prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions.” The FDA required prescription testosterone product manufacturers to add information to testosterone product labeling reflecting the fact that the “benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.”

In October 2016, the FDA announced label changes for prescription testosterone products, warning of the risks of possible adverse health problems, especially heart problems and mental health concerns when testosterone is abused or dependency develops.

“The new Warning will alert prescribers to the abuse potential of testosterone and the serious adverse outcomes, especially those related to heart and mental health that have been reported in association with testosterone/AAS [anabolic androgenic steroid] abuse,” the FDA announcement said.

Holding Testosterone Drugmakers Accountable

In June 2014, a federal panel consolidated 45 lawsuits against manufacturers of testosterone-treatment drugs into a multidistrict litigation (MDL) in Illinois. MDLs save time and money by consolidating cases during the pre-trial proceedings.

“We are typically hesitant to centralize litigation on an industry-wide basis,” the Court said in its transfer order. “In these circumstances, however, we think it is the best solution. Plaintiffs suggest that related cases will number in the thousands.”

As of early 2017, there were more than 6,000 cases in the MDL.

The filed complaints claim that the plaintiff or deceased suffered a heart attack, stroke, deep vein thrombosis, or pulmonary embolism after the plaintiff or a family member began taking TRT drugs.

Up to eight bellwether lawsuits over AndroGel from the MDL are scheduled to go to trial between June 2017 and January 2018.   Bellwether cases, chosen from lawsuits in the MDL, let parties on all sides gauge how juries will respond to the evidence.

How Weitz & Luxenberg Can Help

Weitz & Luxenberg has three decades of experience litigating and winning complex medical cases. The firm has won more than $17 billion in verdicts and settlements for victims of faulty drugs and devices.

While a record of past success is no guarantee of future outcomes, Weitz & Luxenberg attorneys have the experience and resources at their disposal to seek justice for clients.

If you or a family member suffered a heart attack, stroke, DVT, or PE after taking testosterone, you may be entitled to compensation. Weitz & Luxenberg can help you understand your options starting with a free consultation.

Call Weitz & Luxenberg at (888) 829-2203 or fill out the contact form on this page and one of our representatives will be in touch with you shortly.

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  21. NBC News. Health. (2014, January 29). Study Confirms ‘He Hormone’ Link to Heart Attacks. Retrieved from http://www.nbcnews.com/health/mens-health/study-confirms-he-hormone-link-heart-attacks-n18801
  22. Martinez, C. (2016, November 30). Testosterone treatment and risk of venous thromboembolism: population based case-control study. Retrieved from http://www.bmj.com/content/355/bmj.i5968
  23. McCoppin, R. (2015, September 21). Controversy over testosterone therapy lands in Chicago court. Retrieved from http://www.chicagotribune.com/lifestyles/health/ct-testosterone-therapy-lawsuits-met-20150921-story.html
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  26. U.S. Food and Drug Administration. (2015, March 3). 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. Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm
  27. U.S. Food and Drug Administration. (2016, October 25). FDA approves new changes to testosterone labeling regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS). Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm526206.htm
  28. United States District Court. U.S. Judicial Panel on Multidistrict Litigation. (2014, June 6). In re: AndroGel Products Liability Litigation MDL No. 2545: Transfer Order. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2545-Initial_Transfer-05-14.pdf
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  30. United States District Court. Northern District of Illinois. (n.d.). In re: Testosterone Replacement Therapy Products Liability Litigation; Member Cases, MDL 2545. Retrieved from http://www.ilnd.uscourts.gov/mdl-details.aspx?
  31. United States District Court. Northern District of Illinois. (n.d.). Schedule for AbbVie Bellwether Cases; MDL 2545. Retrieved from http://www.ilnd.uscourts.gov/mdl-details.aspx?UGlDS1bLxpRHyfdf3l5DJQ==

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