Lawsuit Overview

Important Low Testosterone Medication and Treatment Updates

Recently, several studies have called into question the safety of treatment with topical testosterone products such as AndroGel. On January 31st, 2014, the United States Federal Food and Drug Administration (FDA) issued a safety announcement indicating that the agency "is investigating the risk of stroke, heart-attack, and death in men taking FDA-approved testosterone" treatments.

As of February 2014, five men have initiated lawsuits against the makers of AndroGel, Abbott Laboratories and AbbVie, Inc., alleging adverse cardiac events resulting from the prescribed treatments.

One individual has filed a lawsuit against Auxilium Pharmaceuticals, Inc., the maker of Testim, claiming the maker misled consumers indicating the drug was a safe option for treating low T symptoms.

Potential lawsuits against various makers and manufacturers of low T medications are currently being reviewed and analyzed.

Why Do Men Use Low Testosterone Treatments and Medications?

The hormone testosterone is often associated with healthy male sexual functioning, such as the growth of male sex organs and sex drive. Testosterone also plays a key role in muscle mass and strength, emotional well-being, energy levels, hair growth, and even fat distribution.

This essential hormone can decrease as men age, known medically as Andropause. While Andropause is a natural process as the body ages, the side effects like decreased muscle mass can lead some men to seek treatments to increase their Testosterone levels.

Low Testosterone Symptoms

Low testosterone, also referred to as "low T," can present many symptoms and/or complications. Some of the more common symptoms include:

  • Irritability
  • Depression
  • Fatigue
  • Lack of concentration
  • Hair loss
  • Loss of muscle mass or bone mass
  • Erectile dysfunction
  • Low libido (sex drive)
  • Low semen volume

It's important to note that some low T symptoms can be subtle and undetected without medical intervention. Duke Medicine recommends men aged 30-40 receive a physical exam every other year, men aged 40-50 should get a physical every 1-2 years, and men over the age of 50 should receive annual physicals.

Testosterone Replacement Therapy Options

It's a good idea for men who experience the above mentioned low T symptoms to consult with their doctor. A doctor should be consulted before beginning any low T treatments.

If you suffer from low T, your doctor may find it helpful to prescribe one of the following testosterone replacement therapies or medications:

  • Implants - testosterone can be implanted in pellet form into soft tissue.
    • Testopel
  • Injections - testosterone can be injected into muscles.
    • Depo Testosterone
    • Delatestryl
  • Skin Patches - there are skin patches that can be worn on the arm or upper body.
    • Androderm
  • Gels - clear testosterone gel can be absorbed through the skin.
    • Androgel
    • Axiron
    • Fortesta
    • Bio-T-Gel
    • Testim
  • Mouth Patches - patch or tablet that adheres to the upper gums and delivers testosterone to the blood.
    • Striant

Potential Testosterone Replacement Therapy Benefits

The benefits of any testosterone replacement therapy vary from patient to patient and can include an increase or improvement in:

  • Energy
  • Muscle mass
  • Bone density
  • Sex drive
  • Erections

Heart Attack, Stroke and Death Risks Associated with Low T Therapy

Two studies have separately indicated that using testosterone replacement therapy products can increase a person's risk of heart attack, stroke, or death. The first study, published in late 2013, in the Journal of the American Medical Association (JAMA) indicated that testosterone replacement therapy could increase these risks by as much as 30 percent.

A second study conducted also indicated an increased risk of adverse cardiac events in older men, as well as in younger men who had a pre-existing heart condition. The results indicated a two-fold increase risk of heart attack in men 65 and older within the first 90 days of treatment, and a two to three-fold increase in men under 65 who had a pre-existing heart condition within the first 90 days of treatment.

In addition to the risk of heart attack, stroke and death, there have been other serious health problems linked to treatments of low testosterone, including:

  • Prostate cancer
  • Worsened sleep apnea
  • Hormone imbalance

Testosterone Replacement Therapy Lawsuits

With so many severe side effects associated with the treatment of low testosterone, lawsuits have already been filed against certain makers and manufacturers and there are many more anticipated. Potential lawsuit accusations include negligence in failing to research and determine potential risks as well as negligent direct marketing to consumers, which led otherwise healthy men to seek out low T treatment(s).

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