A recent study published in the Journal of American Medical Association in November, 2013, has many men wondering about the safety of the testosterone supplements they are taking—likely in response to a marketing storm by testosterone manufacturers regarding “Low-T.” Sales of testosterone drugs, which come in creams, gels, implants, pills and transdermal patches, are up over 90% in the past five years alone, bringing in over $2 billion each year. Spending on television and print ads for testosterone supplements has increased 170% in the past three years, totally about $14 million in 2012.
What You Need to Know About Androderm
Androderm testosterone supplement is delivered via a transdermal patch, which comes in 2.5 and 5.0 mg. strengths. Androderm gained FDA approval nearly two decades ago on September 29, 1995. In 2012, Watson Pharmaceuticals, the manufacturer of Androderm, racked up $87 million in sales of the testosterone supplement. In 2011, the FDA approved Watson’s application for a new formulation which represented a 20% reduction in the active ingredient—testosterone. Approval of the lower-dose formulation was based on a trial showing 97% of the subjects achieved normal levels of testosterone within 28 days of beginning the daily therapy.
Watson states that Androderm is “indicated as testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Low testosterone affects an estimated 13.8 million men in the U.S.; its prevalence increases with age.”1 Watson also notes that the Androderm patch “simulates the circadian rhythm of testosterone observed in healthy young men.”1This statement may well be at the crux of the testosterone debate. A man’s testosterone levels peak around the age of 30. From this point on, levels of testosterone will decrease from 1-3% each year.
Data from the Massachusetts Male Aging Study notes that approximately 2.4 million men aged 40-69 suffer from hypogonadism in the United States. Hypogonadism is a medical diagnosis given to men whose body does not produce testosterone as it should, and Androderm—like other testosterone drugs—received FDA approval only for the treatment of hypogonadism, endocrine tumors or for men undergoing chemotherapy. Men who have decreased levels of testosterone due only to the natural effects of aging do not suffer from hypogonadism.
In other words, a reliable research study states 2.4 million American men suffer from hypogonadism, over five million prescriptions are written for testosterone supplements annually, and Androderm’s manufacturer states that low testosterone affects 13.8 million men in the United States. These discrepancies point to the fact that scores of older men are currently taking testosterone therapy based on nothing more than the normal “symptoms” of aging: loss of bone density, loss of strength and muscle mass, intermittent erectile dysfunction, loss of sexual libido, a decrease in energy, and an increase in belly fat.
Absent indications of serious health risk among men taking testosterone supplements, this quest for the fountain of youth might not be so alarming. Unfortunately, evidence does exist that men taking testosterone supplements have a significantly increased risk of heart attack, stroke, deep vein thrombosis, pulmonary embolism and death. Watson Pharmaceuticals notes that sleep apnea may occur in those taking Androderm and that patients should be monitored for PSA levels, liver function, lipid concentrations, hematocrit and hemoglobin while taking Androderm. Watson cites one clinical study which notes only that nearly half of the study participants developed skin irritation from the patch, however this “study” was comprised of only 36 patients.1
Androderm, like other testosterone supplements, may carry a significant risk of heart attack, stroke, deep vein thrombosis, pulmonary embolism and death. If you feel you have suffered injury as a result of taking Androderm, or any other testosterone supplement, it could benefit your future to speak to a knowledgeable testosterone injury lawyer to determine whether grounds for a lawsuit exist.
1. http://pipelinereview.com/index.php/2011102145898/Small-Molecules/FDA-Approves-Watsons-Androderm-testosterone-transdermal-system-2-mg/day-and-4-mg/day.html