FDA Calls for Testosterone Label Changes Amidst Questions about Cardiovascular Risk
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Testosterone products approved by the U.S. Food and Drug Administration (FDA) will now need to clarify approved uses and provide information on possible cardiovascular risks.
The agency announced these changes on March 3, 2015.
The labeling changes are prompted by two concerns.
First, the FDA has approved testosterone therapy only for treatment of hypogonadism - low testosterone due to medical conditions.
Testosterone has not been approved for age-related testosterone declines. The FDA says more research is needed in this area. New labeling should make this clear.
Second, manufacturers of testosterone must now conduct further research on potential cardiovascular risks associated with testosterone therapy and note these possible risks on package labels.
This change is the result of recent research suggesting an increased risk of heart attack and stroke in certain patients.
However, such risks are a matter of debate among professionals and the research methods of these studies have been questioned.
In January, members of the Androgen Study Group published a review of dozens of studies on testosterone and cardiovascular risk. The report appeared in Mayo Clinic Proceedings.
The members noted that four studies found increased risk. But many more showed "a beneficial effect of normal [testosterone] levels on [cardiovascular] risks and mortality."
The authors added, "In summary, there is no convincing evidence of increased [cardiovascular] risks with [testosterone] therapy. On the contrary, there appears to be a strong beneficial relationship between normal [testosterone] and [cardiovascular] health that has not yet been widely appreciated."
For more information on both the FDA rules and the literature review, please click here.
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