Thursday, February 13, 2014

Low Testosterone Medications and Gels – Increased Risk of Non-fatal Myocardial Infarction?

Attorneys in my office are investigating a claimed link between these medications and heart injuries:
404 373 1800

Testosterone: What is itIn the fetal and embryonic stages of development, testosterone promotes the development of the scrotum and the formation of the structures involved in production. 

In adulthood, testosterone may play a part in sexual function, libido, hair loss, and it may play a role in the accumulation of abdominal fat.As men age, their testorone levels may slowly decline. This occurrence has been called “viripause”, “andropause” or “male menopause.”

This menopause may be caused by the testosterone receptors becoming less receptive, while the amount of free testorone in the body decreases. The decrease is due to an increase in a blood protein that binds with the hormone, rendering it useless.

The gradual fall in the testosterone levels (from 30 to 40 percent) is common in men between the ages of 48 and 70. As testosterone levels drop, men may experience a loss in muscle strength and function, increase in body fat, decrease in body density and a decrease in sexual function and drive. Of course, your physician first needs to rule out other medical causes for those changes.

From a study release in January, 2014, there is this discussion point: In older men, and in younger men with pre-existing diagnosed heart disease, the risk of MI following initiation of TT prescription is substantially increased.

From the study:

We examined risk of MI with TT prescription in all subjects. Since previous studies indicated that cardiovascular events appeared early in treatment, we focused on the 90 day interval following the filling of a first prescription. For those who did not refill their prescription, we also assessed the interval of 91–180 days. To examine potential effect modification by pre-existing disease, we estimated the effect of TT prescription by prior history of a heart disease diagnosis (ICD-9: 404, 414–414.07, 420–429). We also examined the RR for PDE5I and compared the RRs in the TT prescription and PDE5I cohorts.


Among men aged 65 years and older, we observed a two-fold increase in the risk of MI in the 90 days after filling an initial TT prescription, the risk declined to baseline in the 91 to 180 days after initial TT prescription, among those who did not refill their prescription. Since we censored follow-up at the first refill, and the supply for most prescriptions was 30 to 90 days, it is likely that there was little use of the medication in the 91 to 180 day post-prescription interval when the risk declined.

What are the products?
Testosterone therapy is most often administered as a gel, patch or injection. The following products treat low testosterone:
  • Androderm (Actavis) – patch applied to the skin
  • AndroGel (AbbVie Inc.) – topical gel applied to the skin
  • Axiron (Lilly USA, LLC) – topical cream applied to underarm
  • Bio-T-Gel (Teva Pharmaceuticals) – topical gel applied to skin
  • Delatestryl (Endo Pharmaceuticals) – injection or solution
  • Depo-Testosterone (Unigen Life Sciences) – injection solution
  • Fortesta (Endo Pharmaceuticals) – topical gel applied to skin
  • Striant (Auxilium Pharmaceuticals) – buccal tablet absorbed through the gums
  • Testim (Auxilium Pharmaceuticals) – topical gel applied to skin
  • Testopel (Auxilium Pharmaceuticals) – subcutaneous pellet

Risks of testosterone therapy

Men undergoing low T therapy with the following signs of health problems had the greatest increased risk of suffering a heart attack or stroke while taking low T treatments.
  • plaque buildup
  • artery blockage
  • high cholesterol
  • diabetes
  • obesity
One doctor has explained: Testosterone increases the production of red blood cells, which can clump together or coagulate, essentially making blood thicker. That may be especially hazardous in men who have narrowed arteries because of aging and disease.

Talk with us if you think that you have a serious heart condition that you worry may be linked to use of any one of these products

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