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.