Testosterone Warnings Update: Cardiovascular Risk Information Added to Label

Austin Kirk

By Austin Kirk
Posted March 3, 2015


Following a continuing stream of evidence establishing a link between side effects of testosterone drugs and cardiovascular problems, the FDA announced this week that new label warnings will be required for popular drugs like Androgel, Axiron, Testim and other “low T” treatments.

The lawyers at Saiontz & Kirk, P.A. represent men throughout the U.S. who are currently pursuing a testosterone drug lawsuit, alleging that manufacturers of the drugs failed to adequately warn about the risk of users suffering a:

  • Heart Attack
  • Stroke
  • Blood Clots
  • Other Cardiovascular Injury

Today, the FDA issued a drug safety communication that may provide additional support for these claims.

Testosterone Heart Attack, Stroke Warnings

The FDA announced that new testosterone warnings will be provided to ensure that men considering use of the drugs will now be aware of the possible increased risk of heart attacks and strokes.

Drug manufacturers are also being ordered to clearly indicate the limited reasons that men should use testosterone therapy, which are only approved for men suffering from hypogonadism or another medical condition that has caused confirmed drops in testosterone levels.

Benicar Injury Lawyers

Have Your or a Loved One Suffered Cardiovascular Problems on Testosterone?


These new warnings clearly contradict the marketing strategy used by the drug makers over the past decade, which have pushed use of “low T” drugs for men suffering any variety of symptoms typically associated with the natural aging process, such as decreased energy levels, reduced strength and a lack of sex drive.

The FDA warns men taking the drugs that they should seek immediate medical attention if they begin experiencing symptoms of a heart attack or stroke on testosterone, including:

  • Chest Pains
  • Trouble Breathing
  • Weakness in One Side Of the Body Or One Part of the Body
  • Slurred Speech

These new warnings come following a year-long safety review first announced by the FDA in late January 2014, which was sparked by a number of studies that suggested certain men may face an increased risk of heart attacks, strokes or sudden death while using testosterone replacement therapy.

In response to the concerns, the FDA convened advisory panel meetings last year, which determined that the current evidence is unclear on the heart risks associated with the drugs. However, the committee also urged the agency to require more restrictive labeling that indicates testosterone drug use should be limited to men with hypogonadism that has been verified by laboratory testing and that the drugs should not be used as a “lifestyle” drug or for men who are experiencing the natural lowering of testosterone due to aging.

However, the FDA’s statement indicates that the agency is going much further, while acknowledging the advisory committee’s findings:

“Based on our findings, we are requiring labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use. health care professionals should make patients aware of this possible risk when deciding whether to start or continue a patient on testosterone therapy. We are also requiring manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products.”

Testosterone Cardiovascular Lawsuits

As the testosterone heart attack litigation continues to move forward through the court system, the lawyers at Saiontz & Kirk, P.A. are continuing to review potential Androgel lawsuits, Testim lawsuitsAxiron lawsuits and other low T drug lawsuits for men throughout the U.S.

All cases are being pursued by our attorneys under a contingency fee agreement, which means that there are no out-of-pocket expenses to hire our law firm. We only receive attorney fees or reimbursed expenses if we are successful obtaining a financial recovery in your case.

To review whether you, a friend or family member may be entitled to pursue a claim for testosterone cardiovascular problems, request a free consultation and case evaluation.

No Comments • Add Your Comments

Add Your Comments

  • Have Your Comments Reviewed by a Lawyer

    Provide contact information below and additional private comments if you want an attorney to contact you to review a potential case.

    The information below will not be published to this page.

  • NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

  • This field is for validation purposes and should be left unchanged.