Dr. Kathy Maupin and Brett Newcomb discuss the FDA’s decision to mandate a warning label that testosterone replacement causes heart attacks and strokes, and the validity of that claim.
As of June 20, 2014 the FDA is requiring testosterone prescriptions to carry a warning that testosterone could cause a heart attack or a stroke. They have done this presumably because of the flooding of the media with ads from lawyers who are marketing for class action litigants who may have had a stroke while on testosterone. This litigation is due to a very misleading medical study that was released recently.
There is no conclusive science that connects testosterone with blood clots, strokes or heart attacks in men or women—although these warnings are primarily targeting men. There was a study which has been pretty seriously questioned that was done in the VA hospital with a patient population of elderly veterans who had histories of strokes and heart attacks. The results of this study showed that there were more heart attacks among this problematic subject group. The question then becomes whether or not the testosterone caused the increased heart attacks. Is a population of patients that are already suffering from heart problems an appropriate focus group?
There are many studies in the past which have proved that testosterone did not cause strokes or heart attacks. Because of the misleading study from the VA, doctors and patients are now beginning to question whether or not to prescribe or to receive testosterone replacement therapy. There is no data that connects testosterone with clotting. Testosterone does not increase coagulability of blood. You can get blood clots if you are on testosterone, but it is not the testosterone that causes them. In fact, testosterone decreases the coagulability of blood and improves the oxygenation of your tissues. The other risk factors for heart attacks and strokes include high cholesterol and inflammation. Testosterone decreases both of these risk factors. All in all, there are no risk factors known to medicine that are increased by testosterone replacement. People who take testosterone by all the measures by which we judge risk of heart attack, stroke, and blood clots, are decreasing their risk.
Why would the FDA then require a warning on testosterone? We are not sure, they do not spell it out. What we are assuming is that they are reactively trying to cover the bases just in case. Our objection is that they are responding to a fear created by marketing by lawyers and one misleading study. They are an agency who should be above that type of knee jerk response. They are becoming an agency that does not think for itself but runs from controversy by avoiding any potential culpability. This generates anxiety and concern.
What is bad about this warning placed on testosterone by the FDA is that those men and women who would benefit from replacing their testosterone may choose to abandon their medication as the result of a rumor-like consideration. Testosterone is both a hormone that improves the quality of life for men and women and can be life-saving in the long-run.
Remember, causation and correlation are not the same thing. Just because events are connected in time does not mean that one causes the other to happen! We always encourage people to be informed consumers, and to get information and make decision based on facts, not rumor and not anxiousness. Look at the research that is out there, speak with your physician, and make an informed decision about any medical treatment you are considering.
Watch this week’s podcast to put yourself on the track of obtaining the information you need to help you and those you love make good decisions about healthy aging.