Consumer Lawyers

Archive for February, 2014|Monthly archive page

Low Testosterone Medications and Gels – Increased Risk of Non-fatal Myocardial Infarction? – See more at:

In FDA Warning on February 12, 2014 at 9:35 pm

My office is investigating these products, so call me if you have questions: Mark Zamora, 404 373 1800

In the fetal and embryonic stages of development, testosterone promotes the development of the penis and scrotum and the formation of the structures involved in sperm production. In the pubescent years (age 9 to 14), testosterone helps in the growth of the testes, body hair, muscles and bones as well as sexual maturation and deepening of the voice. In adulthood, testosterone may play a part in sexual function, libido, loss of scalp hair, as well as accumulation of abdominal fat. Between 9 and 14 years of age, the levels of testosterone rise sharply during puberty, which is characterized by enlargement of the testes, pubic and other body hair, muscle and bone growth, deepening of the voice and often acne. If these occurrences are not evident, doctors suggest a number of tests to determine if the male has a condition called hypogonadism.

As men age, their testosterone 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 testosterone 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

– See more at: