Testosterone Case Evaluation

Testosterone is a hormone that promotes the growth of the male reproductive system, contributes to proper sexual function, boosts libido, prevents loss of scalp hair and can reduces the accumulation of abdominal fat

Testosterone therapy or low T treatment is often prescribed to men in order to counteract the age-related decline in the hormone. It helps improve sex drive, bone density and muscle mass. But the benefits and risks of the long-term use of testosterone therapy are not well known

Testosterone therapy is most often administered as a gel, patch or injection. The following products treat low testosterone:

  • Androgel
  • Androderm
  • Axirom
  • Bio-T-Gel
  • Delatestryl
  • Depo-Testosterone
  • Fortesta
  • Striant
  • Testim
  • Testopel


The U.S. Food and Drug Administration (FDA) is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. It has been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. FDA is providing this alert while it continue to evaluate the information from these studies and other available data.


  • Testosterone treatments for men could cause an increased risk of stroke, heart attack or even death.
  • Men with signs of heart problems were more likely to suffer a stroke, heart attack or die compared to healthy men.

Evaluation Criteria

1.       Whether the patient was prescribed Testosterone?

2.       Reason for prescription? Is the patient really in need of testosterone?

3.       Did the patient have any preexisting heart conditions?

4.       Were there any allergies or contraindications for the Testosterone drug?

5.       Dosage and Intake details

Critical Review of

Physician Drug Prescription Details

Pharmacy Dispensing Details

Pharmacy Refill Details

Details of Pharmacy Dispensing Details are taken as Confirmatory

6.       Did the patient develop heart attack, stroke or death after Testosterone intake?

7.       When and where was it diagnosed?

8.       Treatment/management

9.       Follow-up visits for management

10.   Outcome/prognosis

11.   Any medical/surgical history, social history (smoking) that could have had an effect on the injury



Testosterone treatments may increase risks for heart attacks, strokes and death in older men with low hormone levels and other health problems.

Use of the medication has been linked to certain risks, including heart problems, sleep apnea, high red blood cell production, skin reactions, breast enlargement and lower sperm production.

Pre existing heart problems:

Risk for developing complication is higher if the patients have pre existing heart conditions. Studies showed a 30 percent increased risk of heart attack, stroke or death among men with existent heart problems.

Men who did low T therapy with the following signs of health problems had the greatest increased risk of stroke, heart attack or death, according to the study. Heart problems that could potentially elevate the risk of men undergoing testosterone treatments included the following:

  • plaque buildup
  • artery blockage
  • high cholesterol
  • diabetes
  • obesity

Nearly 26 percent of men using testosterone had one of the bad outcomes within three years of the heart test, compared with 20 percent of nonusers. It’s unclear how the hormone might increase heart risks but possibilities include evidence that testosterone might make blood substances called platelets stick together, which could lead to blood clots

Study authors recommended that physicians should prescribe low testosterone treatments with more caution.

Missing Record Communication:

Identify and report on missing medical records/pharmacy bills

Apart from identifying critical missing records that are important for the case, provide a detailed outline on what records are needed, why we need them, how did we get a clue that these records are missing and whether the records missing are confirmatory/probable. This will also help in following up and retrieving the records.

Missing Records are presented in the following format



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