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On March 3, the Food and Drug Administration (FDA) finally announced that it was requiring manufacturers of all approved prescription testosterone products to add a warning to the labeling of these drugs about the “possible increased risk” of heart attacks and strokes.[1] This action follows more than a year of reckless foot-dragging by the agency in the face of accumulating evidence linking testosterone use to an increased risk of dangerous, potentially fatal cardiovascular events.
As f...
On March 3, the Food and Drug Administration (FDA) finally announced that it was requiring manufacturers of all approved prescription testosterone products to add a warning to the labeling of these drugs about the “possible increased risk” of heart attacks and strokes.[1] This action follows more than a year of reckless foot-dragging by the agency in the face of accumulating evidence linking testosterone use to an increased risk of dangerous, potentially fatal cardiovascular events.
As far back as Feb. 25, 2014, Public Citizen petitioned the FDA to immediately add a black-box warning about these risks to the product labels of all testosterone-containing drugs available in the U.S.[2] At that time, the label for these products had no mention of such risks.
Responding with unusual speed, the FDA rejected our petition on July 16, arguing that there was “insufficient evidence” of a link between testosterone and cardiovascular risks for either a black-box warning or a patient medication guide, which we also had requested.[3]
On July 15, one day before the FDA rejected our petition, Canadian regulators took a strikingly different approach, one that placed the interests of patients and public health above those of pharmaceutical manufacturers: Health Canada warned patients and health care providers about the evidence of increased cardiovascular risks with testosterone replacement therapy.[4] The Canadian agency also announced it was working with manufacturers of testosterone products to update the Canadian product labels regarding these risks.
In a statement issued after the FDA’s recent announcement, Dr. Sidney M. Wolfe, the founding editor of Worst Pills, Best Pills News, stated, “In the seven and a half months since the Canadian action, approximately four million prescriptions [for testosterone drugs] 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.”[5]
The FDA’s long delay in mandating warnings about the cardiovascular risks for testosterone in the face of aggressive direct-to-consumer promotion and widespread overprescribing was inexcusable and represents a betrayal of the FDA’s role as an agency in the U.S. Public Health Service.
References
[1] Food and Drug Administration. FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use. March 3, 2015. http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm. Accessed March 10, 2015.
[2] Wolfe S, Carome M. Petition to the FDA to add a black-box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs presently on the market in the U.S. February 25, 2014. http://www.citizen.org/documents/21841.pdf. Accessed March 10, 2014.
[3] Food and Drug Administration. Letter denying Public Citizen’s petition to add a black-box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs presently on the market in the U.S. July 16, 2014. http://www.citizen.org/documents/2184_FDA%20Denial%20of%20Petition_July%2016,%202014.pdf. Accessed March 23, 2015.
[4] Health Canada. Information update — possible cardiovascular problems associated with testosterone products. July 15, 2014. http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/40587a-eng.php. Accessed March 10, 2015.
[5] Public Citizen. 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. March 3, 2015. http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=5430. Accessed March 10, 2015.
