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FDA Belatedly Warns About Testosterone Risks of Heart Attack and Stroke

Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group

The U.S. Food and Drug Administration (FDA) belatedly announced today that testosterone medications have “a possible increased risk of heart attack and stroke with use.”

Public Citizen petitioned(PDF) the FDA for a black box warning concerning this cardiovascular risk on Feb. 25 of last year, but the FDA rejected this petition on July 16, arguing that there was “insufficient evidence” of the link between testosterone and cardiovascular risks for either a black box warning or a patient medication guide, which we had also requested(PDF).

The Canadian government, however, had issued a warning about such cardiovascular risk on July 15, the day before the FDA rejected our petition, stating that “several studies conducted after marketing suggest an increased risk of serious cardiovascular problems (e.g., heart attack and stroke) that may be linked to testosterone replacement products. Although these studies have limitations, they provide evidence in support of this possible association when considered as a whole.”

In the seven and a half months since the Canadian action, approximately four million prescriptions have been filled in the U.S. Had the FDA made this announcement last summer when the Canadian government acted, it would have reduced the number of U.S. prescriptions for and damage from testosterone, a medication of questionable effectiveness for a large proportion of users and one that increases the risk of heart attacks and strokes.

When the FDA rejected our petition last summer, the day after Canada had announced a warning, I stated(PDF):

“[c]onflicting conclusions by the Canadian government … and by the U.S. Food and Drug Administration (FDA) ? in its denial of our February 25, 2014, petition calling for a black box warning about these same risks ? lead to two possible explanations for this discrepancy: (1) Canadian men are more sensitive to the cardiovascular risks of testosterone than American men, thus justifying new warnings in that country, but none, at this time, in the U.S. (2) The FDA is more sensitive to pressure from doctors dispensing more than 7 million prescriptions of testosterone in the past year and from the companies selling billions of dollars of testosterone products during the past year than Canadian regulators.”

The second explanation was correct and, once again, the FDA has forgotten that it is part of the Public Health Service.