FDA Warns That Low T Medications May Be Unsafe Because of Heart Attack and Stroke Risks

When men don’t produce enough of testosterone, they can seek medical treatment through drugs that administer a synthetic form of the hormone.  Testosterone replacement therapy can supplement the low levels of testosterone in some men, sometimes referred to as “low T.”  While these drugs help men whose bodies don’t naturally produce enough testosterone, regulators are starting to raise warnings about possible dangerous side effects.  According to the Food and Drug Administration (FDA), research suggests that low T medications may be unsafe because of greater heart attack and stroke risks associated with these drugs.

Several FDA-approved testosterone replacement products are commercially available, such as Androgel, a topical gel that administers the hormone through a gel that men rub on their arms and hands.  Androgel is the top-selling testosterone-replacement drug accounting for more than $1 billion in annual revenue for drugmaker AbbVie.  The FDA approved Androgel in 2000.  But in the years since, new research has come to light suggesting that such testosterone products can be dangerous, even fatal.  Other low T medications include Testim, Axiron, Depo-Testosterone, Androderm and Fortesta.

Earlier this year, the FDA started to show greater scrutiny toward testosterone drugs.  The agency pointed to published studies and input from an advisory committee, which led the agency to conclude “that there is a possible increased cardiovascular risk associated with testosterone use.”  The FDA said that some of the studies reported an increased risk of heart attack, stroke, or death linked to testosterone treatment, though some other studies did not.  The agency then set a requirement that all prescription testosterone products carry warning labels notifying patients of these possible health risks.  Additionally, the FDA called on manufacturers to conduct additional clinical trials to evaluate the heart attack and stroke risks associated with the products.

If you’re on testosterone therapy, here are the symptoms that the FDA says patients should look for:

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

If you or a loved one has experienced a cardiac event such as a heart attack or stroke or a blood clot such as a DVT or PE after using a low T medication, you may be entitled to compensation.  Contact the low T lawyers at the Levensten Law Firm at www.levenstenlawfirm.com, www.androgellawyers.com or 215-545-5600 for a free consultation.