March 6, 2014

Low-T testosterone replacement therapy drugs like Axiron and AndroGel are being investigated by the FDA. Lawsuits are pending regarding the risk of heart attack, stroke, and death with these low testosterone products.

Low-T testosterone replacement therapy drugs like Axiron and AndroGel are being investigated by the FDA. Lawsuits are pending regarding the risk of heart attack, stroke, and death with these low testosterone products.

Eli Lilly and Company is under fire in Australia for illegally promoting its low-T testosterone gel Axiron. Australian authorities levied a $250,000 fine against the Indiana-based pharmaceutical giant for distributing a brochure about Axiron that encourage patients on testosterone replacement therapy to ask their doctors to switch to Axiron. Although the brochure itself was compliant with Australian law, Eli Lilly’s employees were using the brochure to pressure pharmacists to switch patients to Axiron. In Australia, promoting prescription medicine directly to consumers is illegal.

According to Australian authorities, Eli Lilly’s sales managers encouraged sales staff to engage in these sales tactics for more than a year and the illegal tactics were not isolated to one particular sales representative. Eli Lilly claimed to Australian officials that it did not engage in a widespread sales campaign to promote Axiron and that it immediately disciplined employees found to engage in unlawful sales tactics. But Australian officials found email evidence that indicated otherwise. After Eli Lilly appealed the fine, the Medicines Australia Code of Conduct’s Appeals Committee unanimously rejected the Axiron maker’s argument and upheld the $250,000 fine and agreed that there was a “severe breach” of Australian law.

Although Australian law prevents Axiron from being advertised to the general public, the testosterone replacement therapy drug is regularly and aggressively promoted to Americans. Ads for low-T products are prevalent in magazines, TV shows, and on the Internet, especially media entities with a large male audience like ESPN. Testosterone replacement therapy is marketed like a fountain of youth that will give men more energy, more muscle mass, and higher sex drive. AndroGel testosterone gel, made by Abbott Laboratories and AbbVie Inc., has been promoted with a $20.8 million ad campaign in 2011. Abbott also subsidizes insurance co-pays so AndroGel testosterone prescriptions are cheaper.

Due to widespread advertising and “disease awareness” campaigns promoted by pharmaceutical companies, sales of testosterone replacement therapy products have soured. In 2011, sales of low-T drugs surged 133% to $1.6 billion and are forecast to hit $5 billion by 2017.

But recent medical studies have indicated serious and potentially deadly side effects may be associated with popular low testosterone drugs like AndroGel, Axiron, Fortesta, Testim, and Testopel. A 2010 study published in the New England Journal of Medicine was halted after a higher-than-normal amount of men in the study suffered cardiovascular problems. In 2013, a study published in the Journal of the American Medical Association found that low-T products increased the risk of heart attack, stroke, and death by about 30%. Earlier this year, a study in the Public Library of Science’s peer-reviewed scientific journal PLOS ONE found that testosterone replacement therapy doubled the risk of heart attack in men older than 65 and in men younger than 65 with preexisting heart issues.
In response to these troubling findings, the Food and Drug Administration (FDA) issued a safety announcement on Jan. 31, 2014, stating that it is investigating the risk of stroke, heart attack, and death in men taking testosterone replacement therapy products. According to the release, the FDA had already been monitoring these products but decided to reassess the risks in light of the two recent medical studies on low-T drugs.

Our attorneys with The Cochran Firm, D.C. are actively investigating injuries and damages suffered by men who have taken these low testosterone prescription drugs that were advertised as safe. If you or someone you love suffered health problems while taking a low testosterone product, please contact our team of legal professionals to receive a free case consultation. Because deadlines apply to filing legal claims, we recommend contacting us as soon as possible. All inquiries are free, confidential, and carry no obligation.