In January 2014, the results of a federally funded study implied that testosterone therapy could double the risk of heart attack in males age 65 and older. Products like Androgel, Axiron, Fortesta, Testim and others may put men in danger for not only cardiovascular problems, but also stroke and death, according to the U.S. Veterans Affairs Study.
Now, consumer advocacy group Public Citizen is urging the FDA to order that all testosterone manufacturers add strong warning labels to their products, alerting consumers of the drug’s life-threatening side effects. The group is calling for a “black box” warning — reserved for products that pose risk of serious injury or death — on all supplements in the wake of mounting proof of testosterone-related heart problems.
Manufacturers accused of deceptive marketing
AbbVie’s Androgel has enjoyed the most commercial success in its field. Both Androgel and another popular supplement marketed under the name Axiron retail for a whopping $500 a month. Buoyed by a multi-million dollar marketing blitz, testosterone therapy is targeted to men who may be battling symptoms of low sex drive, fatigue or other signs indicative of middle age.
Abbott Laboratories, former owner of AbbVie, spent $80 million promoting AndroGel last year through direct-to-consumer ads. The company is now facing a handful of lawsuits arguing the hormone caused stroke, congestive heart failure and heart attack.
Charged with conducting misleading and overtly deceptive advertising campaigns, testosterone manufacturers are defending their efforts to reach out to potential customers. The Public Affairs Director for AbbVie said the company’s “low T” ads were “developed to educate men who may be at risk for, or have, low testosterone, so they can have the appropriate dialogue with their physician to determine if testing and treatment may be appropriate.”
But experts contend that these ads duped otherwise healthy older men between the ages of 40 and 65 (consumers who were experiencing normal side effects of aging) that they could stop the hands of time, rev-up their sex lives and boost energy through testosterone therapy. AbbVie went so far as to create a special website where men could take a simple quiz to find out if they were suffering from low testosterone levels.
More than 5.3 million prescriptions for testosterone therapy have been written in the States, earning manufacturers more than $1.6 billion in sales.
The major testosterone treatments on the U.S. market include the following products:
- AndroGel – Manufactured by AbbVie
- Axiron – Manufactured by Eli Lilly and Company
- Androderm- Manufactured by Actavis, Inc. (formerly Watson Pharmaceuticals)
- Fortesta – Manufactured by Endo Pharmaceuticals
- Striant – Manufactured by Columbia Laboratories
- Testim and Testopel – Manufactured by Auxilium Pharmaceuticals
Testosterone therapy timeline
- February 2000– FDA approves Androgel for men 18 or older who have a deficiency of testosterone due to primary hypogonadism or hypogonadotropic hypogonadism
- November 2010/October 2011 – Axiron and Androderm patch cleared by the FDA
- 2000-2011 – millions are spent on “low T” ads, prescriptions for Androgel, Axiron and others increase five-fold to more than 5.3 million in the United States
- June 2013 – Bloomberg reports that testosterone therapy sales are expected to triple from $1.6 billion in 2011 to $5 billion by 2017.
- November 2013 – VA study published in the Journal of the American Medical Association shows testosterone therapy is linked to a 29% increased risk of heart attack, ischemic stroke and death
- January 2014 – FDA issues a safety communication warning consumers of the potential risk of testosterone therapy, announcing they will be investigating further. The agency cites an observational study which found that men under 65 who had a history of heart disease showed a two- to three-fold increased risk of heart attack after testosterone exposure.
- February 2014 – Public Citizen encourages health regulators to add a black box warning on all testosterone therapy products regarding heart problems, stroke and death
- February 2014 – Five Androgel lawsuits were brought against AbbVie and Abbot Laboratories in Illinois district court. Plaintiffs allege that the manufacturers concealed risks about the serious side effects associated with their products.
Androgel injuries prompts new litigation
The product liability suits filed against Androgel manufacturers happened just days after the FDA announced it would be re-evaluating the risks and safety profile of testosterone replacement drugs.
The claimants, who were all between the ages of 50 and 63 when taking the hormone, argue that AbbVie and Abbot Laboratories “deceived potential AndroGel users by relaying positive information through the press, including testimonials from retired professional athletes…while downplaying known adverse and serious health risks.”
With growing evidence supporting the dangers of testosterone therapy, these five claims may only be the tip of the iceberg. Legal analysts speculate that thousands of additional testosterone lawsuits will be brought in the coming months.
Testosterone therapy lawsuits allege that:
- Testosterone manufacturers failed to adequately research the risk of heart attack or stroke, especially among patients with a prior history of cardiovascular disease, diabetes, high cholesterol, obesity and other health issues.
- Manufacturers engaged in deceptive direct-to-consumer ads that suggested normal aging symptoms were really signs of “Low T.” General signs listed included weight gain, decreased libido, and a lack of energy.
How a lawsuit can help victims
Testosterone therapy litigation is still in the early stages, with claims being filed on an individual basis by those seeking compensation for their physical injuries, emotional distress and financial losses. As complaints accumulate in the courts, a petition may be filed to consolidate claims under multidistrict litigation or as a mass tort for more efficient resolution.
Product liability attorneys are currently evaluating claims by men under the age of 70 who have no prior history of heart problems prior to taking testosterone. Monetary damages recovered may include those for medical bills, lost income and reduced earning capacity.
- USA Today, Testosterone therapy doubles heart risk in older men, http://www.usatoday.com/story/news/nation/2014/01/29/testosterone-heart-risks/4967795/
- Medscape, Testosterone Therapy Linked With Adverse CVD Events, http://www.medscape.com/viewarticle/813833
- ABC News, Group Wants Heart Attack Warning on Testosterone, http://abcnews.go.com/Health/wireStory/group-heart-attack-warning-testosterone-22659131
- FDA, FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products, http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm
- Bloomberg, Abbott Labs Sued by Five Men Claiming Androgel Injuries, http://www.bloomberg.com/news/2014-02-05/abbott-labs-sued-by-five-men-claiming-androgel-injuries.html