The
U.S. Food and Drug Administration last week announced it is requiring
testosterone drug manufacturers to include a wider warning about the increased
risk of blood
clots in the veins.
The FDA previously had warned that such clots could occur in
certain patients who developed an abnormal increase in the number of red blood
cells, a condition called polycythemia, but the agency has recently received
numerous reports of such clots occurring in those who are not afflicted with this
complication. Blood clots in the veins include deep vein thrombosis (DVT) and
pulmonary embolism, a potentially life-threatening event that occurs when a
clot travels to the lungs.
Testosterone products are approved for use in men who have
low levels of the hormone due to medical conditions such as testicular failure,
previous use of chemotherapy, or a problem with the pituitary gland. Men with low
testosterone levels may have symptoms such as low sex drive, depression, fatigue
and muscle weakness.
Earlier this year, the FDA announced that it was
reviewing the latest research to determine whether these “Low T” products posed
an unacceptable increase in the risk of strokes, heart attacks, and death in
men who used them. The new warning is not related to this ongoing
investigation.
Testosterone therapy products have been heavily advertised
on television and other medium. Products on the market or about to be launched
include AbbVie Inc's AndroGel, Endo International Plc's Aveed and Trimel Pharmaceuticals Corp's
Natesto. Therapy is typically given in gel, patch or injection form. It
has been reported that sales of AndroGel exceeded sales of Viagra in 2013.
"Low T" litigation has been consolidated into an MDL in the Northern District of Illinois.
Pittman, Dutton & Hellums, P.C. is currently investigating Low T Therapy claims. If you or a loved one were prescribed testosterone therapy and were injured as a result, please contact Booth Samuels at 1-866-515-8880 or by email at booths@pittmandutton.com.
Pittman, Dutton & Hellums, P.C. is currently investigating Low T Therapy claims. If you or a loved one were prescribed testosterone therapy and were injured as a result, please contact Booth Samuels at 1-866-515-8880 or by email at booths@pittmandutton.com.
