Testosterone Side Effects & Allegations of “Off Label” Marketing
Since early 2000, the pharmaceutical industry engaged is aggressive marketing campaigns targeting older men with often “non branded” disease awareness marketing for a condition known as ” Low T”. The campaigns implied that “Low T” was a medical condition and that testosterone replacement would offer benefits. The marketing, however, has been criticized as being “off label” and for omitting serious testosterone side effects discussed below. Litigation is ongoing to determine whether these allegations are true.
In response, on March, 3, 2015, The FDA announced that “prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. 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.”
To date, there is no definitive evidence that increasing serum testosterone for age related symptoms is either safe or beneficial to the patient.
Joe Lyon has been at the forefront on the testosterone replacement litigation since 2013 and filed one of the first lawsuits in the country. He has presented to lawyers around the country on the topic and is actively involved in the discovery process in the multidistrict litigation.
If you would like to discuss your potential case and or learn more about the safety of the products, please call The Lyon Firm for a free consultation.
Testosterone side effects can be more serious than previously thought. The FDA further concluded based on a review of the available science that there is a possible increased cardiovascular risk associated with testosterone use. Based on the findings, the FDA also required the manufactures to increase the warning labels to include additional testosterone therapy side effects. The Lyon Firm is accepting cases for review, where the patient suffered any of the following:
Hypogonadism is a well recognized medical condition caused by Klinefelter’s syndrome, pituitary injury or toxic damage to the testicles. The FDA approved testosterone products for hormone replacement therapy in men with a condition known as “classic hypogonadism”.
No. This is where the disease was created. “Low T” or “Andropause” are age related conditions where a man’s testosterone level drops as he gets older. This is natural. The pharmaceutical industry, however, recognizing that all men will have lower testosterone as they age, and praying on the ambiguity in the diagnostic criteria of lower testosterone levels, promoted the condition of “low t” or “andropause”. With therapy, however, testosterone side effects can for outweigh the benefits. As mentioned above, this type of use is not FDA approved, and the safety and efficacy is not established for patients who do not have “classic hypogondism”.
Nonetheless, the “Low T” marketing campaigns promoted the use of testosterone therapy for the age related lower testosterone targeting general symptomology that may nor may not be associated with low testosterone levels. The symptoms such as decreased energy or decreases in muscle mass may have nothing to do with lower testosterone levels but may be the result of other coexisting conditions, concomitant medications or simply the aging process. The majority of men on testosterone therapy are not those with “classic hypogonadism” but men with “low t’, which is not an indicated and approved use of the drug.
Finkle WD, Greenland S, Ridgeway GK, Adams JL, Frasco MA, et al. (2014) Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men. PLoS ONE 9(1): e85805. doi:10.1371/journal.pone.0085805. (Finding that in older men, and in younger men with pre-existing diagnosed heart disease, the risk of MI following initiation of TT prescription is substantially increased.)
Vigen R., Ho M., Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels. JAMA 2013 Nov; 310(17):1829-1836. (Finding the use of testosterone therapy in this cohort of veterans was significantly associated with increased risk of mortality, heart attacks, and ischemic stroke. The pre-existing presence of coronary artery disease did not modify the findings.)
Glueck CJ, Goldenberg N. et al. Thrombotic events after starting exogenous testosterone in men with previously undiagnosed familial thrombophilia. Trans. Res. 2011 Oct; 158(4):225-34 ( Finding thrombotic events after starting testosterone therapy are associated with Factor V Leiden)
Basaria, S., Coviello, A. Adverse Events Associated with Testosterone Administration. NEJM 2010 Jul; 363(2): 109-122. ( Finding that the application of testosterone gel was associated with an increased risk of cardiovascular events. The data and safety monitoring board recommended that the trials be discontinued early due to a significantly higher rate of adverse cardiovascular events in the testosterone group as compared to the placebo group.)
June 27, 2014 – The FDA has updated Medication Guides for a number of Testosterone products. According to its website, “Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.” For a list of the updates, click here.
June 23, 2014 – Journal Watch reports that the FDA will require an expanded label change to all approved testosterone products to warn of the increased risk for venous thromboembolism. Labels currently address the risk for clots associated with polycythemia caused by testosterone treatment.The action follows reports of blood clots in testosterone users unrelated to polycythemia. The agency says the warning is not related to an ongoing investigation announced in January about possible cardiovascular risks associated with testosterone treatment.
June 7, 2014 – Bloomberg reports that lawsuits against Abbott Laboratories (ABT) and AbbVie Inc. have been consolidated in a Chicago court. The Multi District Litigation suit was consolidated based on the fact that “a significant number” of AndroGel suits already are pending before U.S. District Judge Matthew Kennelly there, a panel of judges said yesterday it its decision to consolidate the cases. Kennelly will oversee pretrial information exchanges as part of the consolidation.
March 12, 2014 – FDA receives over 100 reports of serious medical problems allegedly linked to AndroGel, a product used to treat low testosterone levels. “According to the information provided by the FDA, they have received reports of 42 heart attacks, 18 cerebral vascular incidents (stroke and related ailments), 44 pulmonary embolisms, and 12 deaths” (Source).
February 24, 2014 – Associated Press reports consumer advocacy group, Public Citizen, is petitioning the FDA to add a “Black Box” warning to all testosterone therapy products warning against the potential risk for heart attack.
February 6, 2014 – Diane Rehm discusses risks of testosterone therapy with Dr. Harry Fisch, clinical professor of urology and reproductive medicine, Dr. Adriane Fugh-Berman director of PharmedOut, a research and education project at Georgetown University Medical Center, and Roni Caryn Rabin medical reporter who writes a regular medical consumer column that appears in The New York Times’ science section.
February 4, 2014 – Cincinnati Business Courier: Cincinnati doctor warns of ‘testosterone mills’ as FDA investigates health risks
February 3, 2014 – NY Times, Well: Weighing Testosterone’s Benefits and Risks
February 3, 2014 – NY Times Op-Ed: Don’t Ask Your Doctor About ‘Low T’
January 29, 2014 – PLOS One publishes study finding that in older men, and in younger men with pre-existing diagnosed heart disease, the risk of MI following initiation of TT prescription is substantially increased.
November 23, 2013 – New York Times publishes article, Selling that New-Man Feeling, suggesting that the “IsITLowT” quiz developed by Dr. John Morely, director of endocrinology and geriatrics at the St. Louis University School of Medicine, was drafted hastily in 20 minutes. Dr. Morely says he has “no trouble calling it a crappy questionnaire.”
November 2013 – JAMA study, “Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men with Low Testosterone Levels,” indicated that testosterone administration increased the risk of death, heart attack and stroke by about 30%.
August 2013 – Study published in JAMA, “Trends in Androgen Prescribing in the United States, 2001-2011,” indicates that large portions of men being prescribed testosterone do not suffer from Hypogonadism. According to the study, one third of men prescribed testosterone were diagnosed with fatigue and a quarter of men did not have testosterone levels tested preceding prescription.
January 2013 – Medical Marketing & Media awards two AbbVie executives for their marketing efforts and unbranded campaigns promoting awareness “Low T” as a medical condition.
May 10, 2012 – Are Testosterone Drugs the new Viagra? Published in Bloomberg BusinessWeek.
July 2010 – New England Journal of Medicine Study, “Adverse Events Associated with Testosterone Administration,” was discontinued after high number of men in testosterone group suffered adverse events.
November 3, 2009 – FDA issues black box warning for testosterone gel products.
November 2003 – Institute of Medicine (IOM) publishes Testosterone and Ageing: What Have We Learned Since the Institute of Medicine Report and What Lies Ahead? “A 2003 report by the Institute of Medicine (IOM) surveyed the literature on the benefits and risks of testosterone replacement therapy in older men and identified knowledge gaps and research needs. ” Read the study here.
2003 – Market increases to “up to 20 million men.”
February 28, 2000 – FDA approves AndroGel, company announces that the market was for “four to five million American men.”
1999 – Unimed Pharmaceuticals Inc. (predecessor to AbbVie) requests FDA for approval of AndroGel asserting its use for treatment of hypogonadism, estimating that approximately “one million American men” suffer from the condition.
Diane Rehm on NPR discusses The Risks and Benefits of Prescribing Testosterone
If you or a loved one has suffered an injury due to testosterone therapy, and have questions about the root cause and the legal remedies available to improve quality of life and medical care, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer critical questions regarding testosterone side effects.