Testosterone Black Box Warning Needed for AndroGel, Axiron, Testim, Other Treatments

Austin Kirk

By Austin Kirk
Posted March 3, 2014


An increasing number of men throughout the United States are now pursuing AndroGel lawsuits, Axiron lawsuits, Testim lawsuits, AndroDerm lawsuits and other testosterone treatment lawsuits, alleging that the makers of these popular drugs failed to adequately warn about the risk of heart attacks, strokes, blood clots and sudden death.

Amid these mounting claims, a growing number of experts are also indicating that the warnings provided for consumers are inadequate and need to be strengthened.

Testosterone Failure to Warn Lawsuits

Testosterone Failure to Warn Lawsuits Reviewed for Men Nationwide.


Last month, I wrote about how the Endocrine Socieity was urging doctors to make sure that patients are warned about the potential risk of AndroGel heart problems and the importance of carefully monitoring patients during testosterone treatments.

As concerns continue within the medical community, the consumer watchdog group Public Citizen filed a petition last week with the FDA calling for a testosterone black box warning to be added to AndroGel, Axiron, Testim, AndroDerm and other testosterone replacement therapy medications.

Public Citizen has criticized the FDA’s safety announcement last month, where the agency indicated that it was reviewing the link between testosterone and heart risks, but indicated that it had not yet concluded that users face an increased risk of heart attack, stroke or death.

The petition (PDF) asks the FDA to take the following immediate actions:

  • Place a “Black Box” warning on testosterone treatments, indicating that users may face an increased risk of heart attacks and other cardiovascular dangers.
  • Send a “Dear Doctor” letter to specifically warn physicians about the risk.
  • Require an FDA-approved Medication Guide for testosterone treatments, which would be dispensed to patients when their prescriptions are filled, explaining these new heart warnings.
  • Delay the FDA’s decision on whether to approve a new long-lasting testosterone injection that would be marked as Aveed.

These proposed warnings mirror some of the claims raised in the mounting testosterone litigation, which allege that the manufacturers knew or should have known about the heart risks from testosterone side effects, yet failed to provide sufficient warnings to consumers or the medical community.

While withholding this important safety information, manufacturers of AndroGel and other similar products have aggressively marketed their products for use among men suffering from “low T”, resulting in use among thousands of men who have no medical need for testosterone replacement therapy. These men were deprived of the ability to make an informed decision about whether the risks associated with the treatment outweigh the potential benefits.

Public Citizen’s conclusion to the petition highlights the importance of providing these stronger warnings as early as possible, indicating (emphasis added):

[T]he rapidly accumulating evidence from both randomized, placebo controlled trials and from observational studies… make it clear that testosterone treatment increases the risks of cardiovascular disease, including heart attacks. For the FDA to continue to further delay action because, as it said in its January 31 announcement, it ‘has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death,’ is a betrayal of its role in the U.S. Public Health Service.

The FDA announcement did make clear that ‘testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy. … None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.’

But the hyped-up nature of the “low-T” advertising campaigns ensures that many U.S. men who do not meet the FDA-specified criteria of both low testosterone and an associated medical condition due to hypogonadism are taking the products nonetheless. Evidence of the success of these campaigns can be seen in the recent finding that almost 25% of men prescribed testosterone in this country had not previously even had a blood test to determine if their testosterone level was low.

Unless the FDA immediately begins to provide adequately strong black box warnings about the risk of heart attacks and other cardiovascular diseases, the continuing toll of heart attacks in people who are not even candidates for testosterone will continue. At the present rate of prescribing, approximately 13,000 prescriptions for testosterone products are filled each day in this country. Each day of delay of the boxed warning ensures much more exposure, too often for men who cannot benefit from the drug but will only be exposed to its risks.

Testosterone Heart Injury Lawsuits

The testosterone injury lawyers at Saiontz & Kirk, P.A. are providing free consultations and claim evaluations for men and families of individuals who may have suffered a serious or fatal injury after using AndroGel, Axiron, Testim or another testosterone treatment. Lawsuits are being reviewed for individuals who have suffered:

  • Heart Attack
  • Stroke
  • Pulmonary Embolims, Deep Vein Thrombosis (DVT) or Other Blood Clot Injury
  • Wrongful Death

All testosterone injury cases are being handled by our law firm on a contingency fee basis, which means that there are no out of pocket expenses to pursue a lawsuit and we receive no attorney fees or expenses unless a recovery is obtained.


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