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FDA rejects petition for black box warning on T meds


The FDA has rejected Public Citizen’s petition to have a black box warning placed on the labels of testosterone-containing drugs available in the United States.

The FDA has rejected Public Citizen’s petition to have a black box warning placed on the labels of testosterone-containing drugs available in the United States.

The decision was criticized by Public Citizen, which pointed out what it deemed a discrepancy between the FDA’s denial of the warning and a recent “information update” from Canada’s department of national public health regarding possible cardiovascular problems associated with testosterone products.

Related - New study: No increased risk of MI with testosterone

Public Citizen, which describes itself as an advocacy group that “champions citizen interests before Congress, the executive branch agencies, and the courts,” petitioned the FDA on Feb. 25, 2014 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.” In its July 16 response, the FDA wrote, “At this time, there is insufficient evidence of a causal link between testosterone therapy and adverse cardiovascular outcomes to support the regulatory actions requited in your petition.”

The FDA also criticized the four studies-including the JAMA and PLOS One studies that prompted the FDA’s investigation into the safety of testosterone-cited by Public Citizen as evidence of testosterone’s risks, saying the studies “have significant limitations that weaken their evidentiary value for confirming a causal relationship between testosterone and cardiovascular outcomes.”

The FDA added that it is continuing to evaluate the safety of testosterone, and is awaiting the results of the Testosterone Trial, the data from which the FDA believes “will yield important information regarding the safety of testosterone with regard to cardiovascular risks.”

The issue of cardiovascular risks of testosterone will be raised at a Sept. 17 joint meeting of the Bone, Reproductive, and Urologic Drugs Advisory Committee and Risk Management Advisory Committee. Specifically, according to the FDA’s website, “The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use.”

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In a statement, Sidney Wolfe, MD, of Public Citizen’s Health Research Group, wrote that in light of Health Canada’s announcement and the FDA’s denial, “The inescapable conclusion is that Health Canada is more urgently concerned with the health of Canadians and the FDA is more willing to further delay any important safety warning about heart attacks and strokes, partially in deference to the doctors and drug companies who are so enthusiastic about dispensing and selling these products.

“Our statement in the February petition that FDA was reckless then for stating that it ‘has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death’ is further buttressed by the recent reckless announcement today, contrasting sharply with that of Canada,” Dr. Wolfe said.

“The agency needs new, more public health-oriented leadership,” he added.

The Health Canada statement explained that the department, upon completing a safety review on testosterone products, found “a growing body of evidence… for serious and possible life-threatening heart and blood vessel problems such as heart attack, stroke, blood clot in the lungs or legs; and increased or irregular heart rate with the use of testosterone replacement products.”

Health Canada added that it is working with manufacturers to update Canadian product labels regarding this risk.

Look for comprehensive coverage of the ongoing testosterone controversy in the August issue of Urology Times.

More on Testosterone

Positive data on T products follow blood clot warning

FDA approves another testosterone replacement gel

TRT shows benefit, no harm in post-RP patients

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