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Statement: Contrasting Actions by Health Canada and the FDA on Testosterone

View the Statement as a PDF.

View the FDA Response to our Petition.

In a response to the Food and Drug Administration’s (FDA’s) denial of a petition to add a black-box warning to the product labels of all testosterone-containing drugs on the market in the U.S., Public Citizen notes that Health Canada took drastically different action in the same week. The Canadian agency issued a health warning to patients and health care providers about the serious cardiovascular risks of testosterone products, but the FDA declined to offer a similar warning, leading to the conclusion that the FDA is more sensitive to pressure from prescribing doctors and drug companies than they are to the nation’s public health needs.