Two expert medical committees have voiced concern over the potential cardiovascular side effects associated with low testosterone medication. The Food and Drug Administration enlisted advice from a joint advisory panel on two controversial issues associated with testosterone related therapy (TRT). The panel discussed the appropriate indicated population for TRT use, and whether the use of Low-T medications, such as AndroGel and Testim, could have adverse cardiovascular effects.
In a 20-1 vote, the advisory committees recommended that the FDA institute labeling requirements on low-T medication to prevent physicians from prescribing the drugs to men experiencing testosterone reduction as a result of natural ageing. The medical experts also called for a more in-depth investigation over the possible cardiovascular side effects of TRT, which may include heart attack and stroke.
The panel received a brief regarding the current state of low-T testosterone medications prior to making any recommendations. According to the FDA brief, from 2009 to 2013, sales of low-T medication in terms of kilograms of active ingredient saw an increase of 65%, with approximately 8,500 kilograms sold in 2009 to 14,000 kilograms sold in 2013. In 2010, 1.3 million patients received a prescription for testosterone and by 2013, this number rose to 2.3 million.
Testosterone medications were originally developed to curb hypogonadism, or abnormally low serum testosterone concentrations. The main cause for the upsurge in TRT prescriptions was seen amongst the 40 to 64 age demographic. In 2010, only 850,000 TRT prescriptions were recorded amongst the group, but by 2013, that number had increased to 1.5 million.
Only about half the men taking testosterone therapy during that time had been diagnosed with hypogonadism. A quarter of the men didn’t even have evidence of their testosterone concentrations being tested prior to beginning TRT. In fact, 21% of patients prescribed TRT did not have evidence of laboratory testing for serum concentrations at any time during the entire treatment. The FDA described this as a “particularly concerning” issue, as it is difficult to calculate the proper dose of testosterone for a patient if the physician is without serum concentration evidence.
At the meeting, panelists concluded that TRT use should be limited to men that actually had hypogonadism or pituitary gland disorders. The advisory panel noted that, given the current data, this was likely a minority of users.
The panel, in a 16-4 vote, urged for further investigation on the link between low-T medication and adverse cardiovascular side effects.
Recent studies have yielded mixed results over the question of whether low-T drugs have negative impact on the heart. The lack of actual TRT users suffering from hypogonadism has created uncertainty about what side effects are possible. In his presentation to the panel, Shalender Bhasin, MD, of Harvard Medical School, echoed this concern.
“In young men with classical hypogonadism, testosterone replacement therapy improves symptoms with low adverse event frequency. In older men, with age related decline or frailty, neither benefits nor risks have been clearly demonstrated,” Bhasin said.
Results from a 2010 clinical study indicate a connection between adverse cardiovascular related effects and testosterone medication. The study divided 209 older aged men, with 106 of the men receiving testosterone, while the remaining 103 received a placebo. 23 of the men receiving testosterone experienced adverse cardiovascular effects during the study, as while only 5 men who were given the placebo experienced such effects.
The National Institutes of Health sponsored a trial similar to the 2010 study, analyzing whether the testosterone hormone actually reduces the risk of heart attack and stroke. Results will not be published until 2015.
A. Michael Lincoff, MD, of the Cleveland Clinic summed up the panel’s overall message regarding the current labeling of Low T medications and the possible cardiovascular risks.
“It’s a weak cardiovascular safety signal,” Lincoff said. “We need to inject some reality into what has really been an uncontrolled use of the drug.”
Ultimately, decisions regarding marketing guidelines, labeling, or any informative wording on side effects, is ultimately left to the FDA’s discretion. That said, the FDA usually implements the recommendations of its expert panels.
If you or someone you know has suffered an adverse health consequence, including heart attack or stroke, while taking a testosterone-boosting gel, cream, or roll-on product, please contact the Cochran Firm, D.C. today. Our experienced product liability and personal injury attorneys are actively investigating claims for compensation arising from low-T medication injuries. Because time is limited we recommend contacting us as soon as possible. All inquiries are free, confidential, and carry no obligation. To get a quick overview on the low-T testosterone litigation, please see our testosterone product infographic.