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Testosterone Stroke Warning

WARNING: ANDROGEL INCREASES RISK FOR STROKE

Testosterone replacement therapies including AndroGel can increase a man’s risk for stroke and other cardiovascular incidents double or triple the normal rate, studies reveal. While on the one hand, endocrinology research has solidified the Androgel stroke connection, pharmaceutical companies on the other are only continuing to ramp up their testosterone marketing campaigns. Concerned by the rising numbers of men now taking prescription testosterone in the U.S. and around the world, critics point to aggressive advertising campaigns that imply AndroGel is effective at treating a wide range of ailments and minimize the risk of stroke. The FDA has only approved testosterone products for treating medical problems caused by hypogonadism, a diagnosable medical disorder. An FDA testosterone stroke warning, issued in 2014, indicates the products are under close scrutiny by the FDA due to the risk for stroke.

Filing a testosterone stroke lawsuit may be the best recourse consumers have to push for corporate accountability for the injustices done to men who suffer from stroke while taking AndroGel. This page includes information about testosterone replacement therapy in general, the scientific findings on AndroGel stroke risks, and information about testosterone stroke warning statements.

Testosterone FDA Warning

FDA AndroGel Stroke Warning

Due to increasing evidence that Androgel and other similar products cause stroke, the FDA has issued a Testosterone Stroke Warning. Multiple studies published since 2010 contribute to a body of literature which suggests the risk of stroke outweighs the potential benefits of the substance in most cases. Safety advocates argue that consumers should be warned of the stroke risk in order to make informed choices.

The FDA AndroGel Stroke Warning was issued on January 31, 2014. Referring to several recent studies, the FDA warning contains information about federal regulators’ investigation of the stroke link. The FDA testosterone stroke warning advises that clinicians take extra caution when prescribing the treatment by weighing the potential benefits of the drug with the testosterone stroke danger. The FDA AndroGel stroke warning also requests that patients and doctors file adverse event reports with the agency’s MedWatch program, in order to contribute to the body of evidence regarding the stroke link.

Understanding the Testosterone Stroke Risk

The connection between AndroGel and stroke is related to the production and behavior of red blood cells. When extra testosterone is introduced to the body, red blood cell production is boosted. Red blood cells have a tendency to coagulate or mass together, leading to a thickening of the blood. Stroke and other health conditions such as heart attack are believed to come from this tendency for the blood to become thicker in the presence of extra testosterone.

AndroGel Stroke Risk

Researchers were already leery of hormone replacement before testosterone replacement therapy became widespread. There was an era in which hormone replacement therapy was common for women; some believed estrogen products were a magic solution to the ailments of menopause. However, when increased risk for stroke, heart attack and other severe health conditions became public, the number of women taking estrogen gradually dropped. Some doctors have suggested that as knowledge of the AndroGel stroke risk becomes public, many men will reject hormone replacement therapy.

AndroGel Stroke Research

The first prominent study that connected testosterone therapy and stroke was published in 2010. Conducted at Boston University’s School of Medicine (and later published by the New England Journal of Medicine), this research was newsworthy because, while only a small study, it was discontinued because too many of the subjects were suffering from severe cardiovascular incidents. The study indicated that men taking testosterone products were five times as likely to have heart attacks or another “serious heart event” such as a stroke as men not taking the supplemental hormones.

The FDA warning cited two more recent studies as grounds for warning consumers of the Androgel stroke risk. In 2013, a study conducted with 8,709 men from the Veterans Affairs health service traced the risk for stroke, heart attack and death by using coronary angiography. This heart evaluation method found that taking AndroGel increased a man’s risk for stroke and heart attack by 29%. On average, the subjects of this study were 60 years old; this research offered evidence on the risk for both younger and older men.

The most recent evidence connecting AndroGel to stroke was published in a study from a group of California-based researchers and endocrinologists in January of 2014. Based on earlier research which showed the stroke risk increased almost immediately when a man started taking AndroGel, this study examined men for only the first 90 days of their prescription. Depending on the age of the subject, men taking testosterone had a two- to three-fold increase in risk for cardiovascular incidents like stroke. This report also discussed the commonality of symptoms between hypogonadism and obesity, warning that many men may be taking AndroGel and exposing them to danger who should not be taking hormone supplements. The study was released online by the journal PLoS ONE in January of 2014.

Low T and the Evidence behind the Testosterone Stroke Connection

Testosterone replacement therapy (TRT) is a treatment that has been developed to treat hypogonadism, a medical disorder in which, for various reasons, the male body produces very little or no testosterone. The ordinary decline in testosterone that is a part of the male aging process is not the same as hypogonadism. Andropause is a term used to describe the male aging process beginning in late middle-age. In fact, the normal decline of testosterone is initiated at age 30, when the hormone’s levels typically start falling about 1% each year.

AndroGel and other similar products are approved by the FDA only to treat men who suffer from medical conditions resulting from true hypogonadism. Blood tests are required in order to determine if a patient has the disorder, and experts warn that AndroGel and other similar products should only be prescribed for those who are experiencing a medical condition resulting from the testosterone deficit, because of the risk of stroke. Hypogonadism can be caused by genetics or chemotherapy, and may be related to a problem in the testicles or a problem in the portion of the brain that controls hormone production. Testosterone products are available in a variety of forms including topical gel, transdermal patch, buccal system (applied on the upper gums or inner cheek), and injection. Numerous companies produce similar products, the most popular of which is AndroGel by AbbVie.


  • ANDRODERM
  • ANDROGEL
  • ANDROID 10
  • ANDROID 25
  • AXIRON
  • DELATESTRYL
  • DEPO-TESTOSTERONE
  • FORTESTA
  • STRIANT
  • TESTIM
  • TESTOPEL
  • TESTOSTERONE
  • TESTOSTERONE CYPIONATE
  • TESTOSTERONE ENANTHATE
  • TESTRED
  • VOGELXO

The term “Low T”, which has been popularized by pharmaceutical companies such as AbbVie, has become a general term that encompasses a wide range of complaints beyond those characterized by true hypogonadism. In fact, the advertising campaigns that have presented the trendy term “Low T” are blamed by many experts for a huge surge in seemingly unnecessary prescriptions for AndroGel. Claiming hormone replacement can resolve erectile dysfunction, improve mood, boost energy, and improve cognitive thinking skills, among other claims, these marketing campaigns have led many men to self-diagnose and request hormone therapy. Advertising for off-label uses of drugs is a violation of federal regulations. Many men taking AndroGel are unaware of the stroke risk, and several have already filed lawsuits. Due to a lack of research on the topic, no one knows if testosterone products really can achieve the claims made by AbbVie and other companies.

Testosterone Advertising Campaigns Gloss Over Stroke Danger; Prescribers and Profits Multiply

Testosterone Stroke WarningWhile researchers have been busy conducting studies and evaluating research to learn more about the AndroGel stroke risk, AbbVie and other pharmaceutical companies have launched unprecedented marketing campaigns they’ve coined “Disease Awareness” efforts. In 2011, $14.3 million was spent on testosterone marking. In comparison, more than seven times that amount, or $107.3 million, was spent in 2012. AbbVie’s website “IsItLowT.com” and other similar marketing tools have been developed to rebrand hypogonadism with the trendy name “Low T”. Featuring dumbed-down quizzes that anyone could fail, and utilizing the star power of retired professional athletes, critics say these marketing campaigns have turned hormone replacement into a catch-all remedy that returns youth and vigor. This incredible surge in advertising suggests manufacturers saw a huge profit opportunity in testosterone. The number of prescriptions issued has tripled since 2001. In 2012, 3 million prescriptions were written for AndroGel alone. The sales of testosterone replacement drugs amassed $2 billion on profits during 2012, and are projected to climb to $5 billion by 2017.

It has been proposed that the testosterone stroke connection has been overlooked or drowned out intentionally by pharmaceutical companies. A comprehensive meta-analysis published by BMC Medicine in April of 2013 examined 169 papers on the topic of testosterone stroke risks. The researchers assert that studies funded by drug companies had a lower rate of stroke than research funded without industry funding:

Overall and particularly in trials not funded by the pharmaceutical industry, exogenous testosterone increased the risk of cardiovascular-related events.

A handful of AndroGel stroke lawsuits have already been filed in which patients claim they were not warned of the connection between testosterone and stroke. It is anticipated that AndroGel stroke lawsuits will increase in volume as the stroke risk is more widely known by doctors and consumers.

More Testosterone Stroke Warnings

The FDA warning is not the only warning that has been released. Consumer Reports has also warned men that the benefits of taking testosterone may be outweighed by the stroke risk. Dr. John Santa, quoted in the Consumer Reports warning, believes many men are using AndroGel unnecessarily and that most men don’t need hormone replacement therapy. Referring to dangers that include stroke and other cardiovascular events, Consumer Reports reminds consumers that testosterone therapy is not necessarily effective. In particular, this stroke warning notes that testosterone therapy has not been approved for or shown to resolve erectile dysfunction (ED). The American Urological Society has included testosterone therapy on its list of overused or dangerous treatments, echoing the warning that hormone replacement therapy is not useful for treating erectile dysfunction and is accompanied by too many severe risks such as stroke.

Testosterone Stroke Warning

AndroGel Stroke Lawyers Help Men and their Families

Our attorneys handling testosterone lawsuits for men who have suffered from stroke, and the family members of persons who have suffered from AndroGel stroke, are expert at representing the interests of individuals against multinational pharmaceutical corporations. They will leave no stone unturned as they prepare your case for trial, and fight to the end to assure you get the compensation you deserve. If you or a loved one suffered from stroke while taking AndroGel, a member of our testosterone lawyer team will be happy to provide you with a free AndroGel claim evaluation.

Testosterone Stroke Lawsuits

Males who have suffered from one or more strokes or other cardiovascular problems while taking testosterone may be eligible to file an AndroGel lawsuit. Our firm provides legal representation for testosterone stroke lawsuits on a contingency basis, meaning that there is no fee for our legal services unless we win compensation on your behalf.