FDA Unwilling to Include Black Box Warnings on Testosterone Replacement Therapy Drugs

The US Food and Drug Administration denied a citizen petition Wednesday from advocacy group Public Citizen demanding the agency to notify consumers of possible cardiovascular risks stemming from use of popular testosterone replacement therapy drugs. Public Citizen's petition, submitted in February, called for a "black box warning" on testosterone drugs' labels emphasizing an elevated risk of cardiovascular disease as a result of taking them. Unfortunately, the FDA decided not to issue a black box warning, citing numerous inadequacies in the studies including insufficient sample sizes and varied ranges of study discontinuation rates.

Public citizen sharply criticized the FDA's decision to reject the petition, while highlighting the recent issuance by Health Canada, the country's equivalent of the FDA. Health Canada's recent proclamation differs strikingly with the FDA's decision, emphasizing a high alert for the cardiovascular risks associated with testosterone products. Morelli Law Firm agrees with Health Canada that these safety risks should be emphasized to properly warn consumers and their physicians.

Consumers who have not received adequate information about the risks of testosterone replacement therapy drugs may have suffered serious injuries as a result. If you or a loved one has suffered a heart attack, stroke, or blood clot following testosterone use, contact Morelli Law Firm immediately.

Categories: Testosterone Lawsuit, News
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