FDA Adds Heart Attack, Stroke Warnings to Testosterone Drugs

The FDA has issued a communication that it is ordering changes to the labels of testosterone medications.  That order states that these labels need to contain information regarding the potential for men to suffer from testosterone medication side effects.  These testosterone side effects include heightened risks for suffering heart attacks and strokes.  The communication also states that these testosterone medications should only be used by men who have a demonstrated medical need.  This is just the latest step in an ongoing controversy that is surrounding these testosterone replacement therapy medications, or ‘TRT’ drugs as they are known to many people.

A link to the communication released by the FDA can be found here.  The communication sets a clear tone almost immediately by stating that the “benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.”  This has been the crux of the issue regarding TRT medications:  whether or not men should be able to use them simply to enjoy some of the benefits that are being marketed in relation to them.  These benefits include:

  • Increase of lean body mass
  • Decrease of fat mass
  • Improved sexual performance
  • Improved mood and overall self-image
  • Increase in bone density

In a more traditional sense, men who suffered from what is called hypergonadism were prescribed these testosterone medications in order to boost their levels of this hormone.

The Explosion of the Testosterone Medication Market

TRT began to gain in popularity around the turn of the century.  Since then, the number of men who have used these medications has grown exponentially.  The first estimates indicated that approximately 500,000 men in the United States were using these medications.  As of now, millions of men are receiving prescriptions for TRT drugs.  Billions of dollars in revenue are being generated by the manufacturers of these medications.  Examples of popular drugs include:

  • AndroGel
  • Axiron
  • Testim
  • Androderm
  • Depo-Testosterone

There has also been an increase in recent years of younger men using these medications when traditionally they were prescribed to men in their 60’s.

Testosterone Replacement Therapy Side Effects

As more and more people began to use these medications, more and more allegations of testosterone side effects began to arise.  Most troubling among them was the common allegation that men were suffering from heart attacks and strokes when using these drugs.  Even the FDA laid out symptoms in its public warning regarding these medications.  Those symptoms included:

  • Chest pain
  • Shortness of breath or trouble breathing
  • Weakness in one part or one side of the body
  • Slurred speech

Testosterone Replacement Therapy Lawsuits

In response to the harm that was allegedly done to men around the country, a large number of testosterone lawsuits have been filed against the manufacturers of these drugs.  If you or someone you love has suffered as a result of TRT, contact the testosterone side effects lawyers at Parilman & Associates today to schedule a free initial consultation.  You can either email the firm or call 800-800-DRUG.