March 4th, 2015
FDA: Testosterone Therapy May Pose Cardiovascular Risks
Physician's First Watch, CardioExchange Staff
Men who use testosterone products to treat low testosterone may be at increased risk for myocardial infarction, stroke, and death, the FDA cautioned on Tuesday. The agency is requiring a label change to warn of these risks and to clarify the approved uses for such products.
The action — which updates a drug safety communication from January 2014 — is based on studies that demonstrated a potential link between testosterone therapy and cardiovascular risks, and on contributions from an FDA advisory panel.
The FDA emphasized that testosterone products are approved only for treating low testosterone caused by medical conditions such as disorders of the brain, pituitary gland, and testicles. Benefits for age-related low testosterone haven’t been demonstrated.
– See more at: http://www.jwatch.org/fw109934/2015/03/04/fda-testosterone-therapy-may-pose-cardiovascular-risks#sthash.46ZoNISE.dpuf