FDA, Health Canada Warn Testosterone Therapy Patients to Carefully Weigh Risks and Benefits


Chances are if you watch late-night television, you see periodic advertisements for clinics specializing in “Low T” treatments for men who have lost a step, or are experiencing a diminished libido attributed to middle age. These treatments consist of topical creams and gels containing the hormone testosterone, which when applied to certain parts of the body can boost energy and make men feel rejuvenated. Unfortunately, some men experience serious adverse side effects from Low T therapy, including heart attacks and strokes.

Government Regulators Have Issued Warnings

In July 2014, the Canadian Press reported that Health Canada, an agency similar to the U.S. Food and Drug Administration (FDA) issued a warning to consumers and medical professionals about potential side effects associated with testosterone therapy.

After reviewing data, the agency pointed to a “growing body of evidence” suggesting that topical prescription testosterone products like AndroGel, AndroDerm, and others should not be used by men if their testosterone levels are not shown to be below the normal range. Moreover, Health Canada recommended that men need to advise their physicians of any history of cardiovascular disease, and that they should be closely monitored if they go ahead with therapy. Further, the agency advised that women, and men under 18 should not use these drugs.

In March, 2015, the FDA issued an addendum to its January 31, 2014 Drug Safety Communication stating that labels on topical prescription testosterone products have been updated to include a warning about the possibility of adverse cardiovascular side effects.

The agency acknowledged that “evidence from published studies and expert input [suggest] that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.”

Pharmaceutical Companies Are Facing Lawsuits

As of October, 2015, there are over 2,700 lawsuits pending in a multidistrict litigation (MDL) in the U.S. District Court for the Northern District of Illinois (MDL 2545, in re: Testosterone Replacement Therapy Products Liability Litigation). Plaintiffs allege that drug manufacturers AbbVie, Endo and others failed to warn them of the risks associated with testosterone therapy, and that the drugs are to blame for serious adverse cardiovascular side effects. They are seeking compensation for damages including medical expenses, loss of income, and permanent injuries.

Moreover, plaintiffs allege that Low T was created by the marketing departments of these pharmaceutical manufacturers, misleading men to think that this was a serious condition. Claims also state, according to an April, 2015 article published on Forbes.com, that Low T marketing has encouraged a “greater extreme” of off-label drug marketing never before seen in the drug industry.

Testosterone Therapy May Be Of Little Benefit to Most Men

A recent study published in the Journal of the American Medical Association (JAMA) suggests that older men with low-to-normal testosterone levels are likely receiving little to no benefit from topical testosterone drugs, including no improvements to quality of life or sexual function. Moreover, the study did not provide any credible data as to the safety of these drugs, suggesting that they could have a negative impact on cardiovascular health if a man has other health concerns such as high blood pressure, diabetes, obesity, or an existing heart condition.

In the face of aggressive marketing, there are currently about 2 million men in the U.S. and Canada receiving treatment for Low T, and it has created a serious health concern among medical professionals. Many believe men are doing themselves more harm than good by using these drugs. It is important to weigh the risks and benefits of testosterone therapy, and take into consideration a family history of heart attacks, strokes and other illnesses when making a decision.

Adverse Effects That Might Be Associated With Testosterone Therapy

Like most prescription drugs, topical testosterone therapy is not unaccompanied by risk. If you’ve experienced one or more of the following, the use of these drugs might be to blame:

  • Heart attack
  • Stroke
  • Mini-stroke (transient ischemic attack)
  • Coronary artery disease
  • Death

In an effort to minimize the risk of adverse side effects, it is always best to consult with your doctor and have a thorough physical examination before embarking on treatment with any prescription medication.

What Can I Do If I’ve Experienced Adverse Side Effects?

If you have experienced one of the side effects listed, and believe that it was caused by your use of topical testosterone drugs, the first step is to seek treatment to determine the cause of your illness.

If your doctor feels your illness was a direct result of testosterone therapy, you have legal options if you wish to explore them.

The attorneys at Morgan & Morgan, PA are currently evaluating individual claims on behalf of men who have been injured by testosterone therapy drugs.

If you would like to explore your legal options, please contact us for a free consultation.