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Testosterone Stroke Warning

WARNING: TESTIM USERS FACE RISK OF STROKE

Recent research into the effects of testosterone replacement therapies such as Testim on men show an increase in the danger of stroke and other cardiovascular events by two- to three-fold. As scientists confirm the Testim stroke connection by publishing respected studies, pharmaceutical companies are funneling more money than ever before into testosterone marketing campaigns. Alarmed at the dramatic increase in men now taking prescription testosterone in the U.S., drug safety advocates blame pharmaceutical companies’ aggressive advertising campaigns which downplay the dangers of stroke but make sweeping claims about the drug’s efficacy. Thus far, testosterone replacement therapy has FDA approval only for the treatment of hypogonadism, a diagnosable medical disorder. An FDA testosterone stroke warning, issued in 2014, warned clinicians and patients of the potential stroke danger and announced an FDA investigation into the testosterone stroke link.

Filing a testosterone stroke lawsuit is the most effective method individuals have to address the injustice done to men who have suffered from stroke while taking testosterone. Unfortunately, one of the only ways corporations take action to protect consumers is when they are threatened with litigation. This page includes information about testosterone replacement therapy in general, the scientific findings on Testim stroke risks, and an overview of the various testosterone stroke warning statements.

Testosterone Stroke FDA Warning

The Testosterone Stroke Connection

Testosterone replacement therapy (TRT) is medically indicated to treat hypogonadism, a hormonal condition where the male body does not produce enough testosterone. The level of testosterone produced by the body naturally drops as men age; beginning around age 30, testosterone levels typically fall 1% each year throughout andropause. Hypogonadism is not the same as andropause; it is a pronounced shortage of testosterone that can have significant impacts on a man’s health.

Testim and other similar products have only by approved by federal regulators for the treatment of health problems relating to verifiable hypogonadism. In order to know if a patient actually has hypogonadism, his serum testosterone levels must be measured through blood tests. Experts warn that, due to the risk of stroke and other health problems, Testim should only be prescribed for patients suffering from some adverse health condition related to low testosterone. Hypogonadism can be caused by genetics or chemotherapy, and can be traced to an ability to produce testosterone or a problem in the portion of the brain that controls hormone production. Testosterone replacement therapy can be prescribed as a topical gel, transdermal patch, buccal system (applied on the upper gums or inner cheek), or injection. Numerous companies produce similar products, one of which is Testim from Auxilium.

ANDRODERM

Watson Labs

TESTIM

AbbVie

ANDROID 10

Valeant Pharmaceuticals International

ANDROID 25

Valeant Pharmaceuticals International

AXIRON

Eli Lilly and Co.

DELATESTRYL

Endo Pharmaceuticals

DEPO-TESTOSTERONE

Pharmacia and Upjohn

FORTESTA

Endo

STRIANT

Actient Pharms

TESTIM

Auxilium Pharms

TESTOPEL

Actient Pharms

TESTOSTERONE

Teva Pharms, Perrigo Israel

TESTOSTERONE CYPIONATE

Paddock LLC, Sandoz, Mylan Institutional, Watson Labs, Bedford, Hikma Farmaceutica, Sun Pharm Inds Ltd  

TESTOSTERONE ENANTHATE

Paddock, Mylan, Watson, Hikma

TESTRED

Valeant Pharm Intl

VOGELXO

Upsher Smith Labs – tentative FDA approval

The term “Low T”, coined by pharmaceutical marketers, has become a catchall phrase that refers to almost any ailment an aging man may have, and is much more broad than hypogonadism. In fact, many clinicians and researchers warning against the overuse of testosterone blame the concept of “Low T” for men who have unnecessary prescriptions for Testim. Advertising which asserts products similar to Testim can resolve erectile dysfunction, improve mood, boost energy, and improve cognitive thinking skills, among other claims, critics say, has led otherwise healthy men self-diagnose and expose themselves to unnecessary risk for stroke. Federal regulations prohibit pharmaceutical companies from advertising their products for off-label uses. Many men taking Testim don’t know about the testosterone stroke connection, and several families 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 Auxilium and other companies.

FDA Releases Testim Stroke Warning in 2014

The FDA Testosterone Stroke Warning was released in response to new data clarifying the link between cardiovascular problems and drugs such as Testim. A body of research conducted since 2010 indicates the increased danger of stroke outweighs the potential benefits of the testosterone replacement in many cases, particularly where the therapy is being used for non-medical or questionable reasons. Drug safety advocates insist that consumers should be made aware of the heightened stroke risk from testosterone in order to make informed choices.

The FDA Testim Stroke Warning was issued on January 31, 2014. Citing numerous recent endocrinology studies, the FDA warning explains the efforts federal regulators are making to investigate the testosterone stroke link. Federal regulators urge doctors to consider their options carefully when prescribing the treatment, weighing the potential benefits of the drug with the testosterone stroke danger. Furthermore, the FDA Testim stroke warning advises patients and clinicians file adverse event reports with the agency’s MedWatch program, as a means to help regulators and the medical community at large to learn more about testosterone stroke.

Testim Stroke Lawyer

How Testosterone Causes an Increased Risk for Stroke

Scientists and endocrinologists believe that the reason testosterone replacement causes an increase in stroke and heart problems is because of the hormone’s effect on the blood. Specifically, testosterone boosts the production of red blood cells in the body. Red blood cells naturally clump together or coagulate, and when the volume of red blood cells increases, thickening may become more pronounced or pose a more severe risk for stroke, heart attack, and other cardiac problems.

More men are taking testosterone replacement drugs like Testim than ever before, and the phenomenon is very recent. Prior to the rise of testosterone replacement therapy, estrogen replacement enjoyed popularity. However, estrogen replacement was largely phased out, except for certain specific uses, simply because of its associated risk of heart problems and stroke. It comes as no surprise that testosterone replacement therapy also has its dangers. Some doctors have suggested that as knowledge of the Testim stroke risk becomes public, many men will reject hormone replacement therapy.

Testim Stroke Research

A study published in the New England Journal of Medicine in 2010 is looked to as the first major proof that Testim and other testosterone replacement therapies the risk for stroke in male patients. Researchers at the Boston University School of Medicine opted to end their research prematurely due to early results that showed an unacceptable risk for cardiovascular problems for patients taking testosterone. The conclusion of this research 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 addressing Testim stroke risks was prompted by two more recent, published in 2013 and 2014. In 2013, researchers tracked 8,709 men through the Veterans Affairs health service with coronary angiography to measure incidents of stroke, heart attack, and death. This scientific study concluded that men using Testim were exposed to a 29% increase in their risk for cardiovascular events including stroke and heart attack. While the average age for this group was 60, this research offered evidence on the risk for both younger and older men.

Federal regulators also referenced a 2014 testosterone stroke study conducted by California-based endocrinology experts. Researchers investigated the immediate effects of testosterone replacement therapy by monitoring men in the first ninety days they were taking the drug. The risk of stroke increases almost immediately, because drugs like Testim immediately increase the body’s testosterone levels. The drug must be used each day to maintain higher hormone levels at a constant rate. This study determined that age played a role in the level of risk men face from taking testosterone, with all men facing a two- to three-fold increase in risk for cardiovascular incidents like stroke while using Testim. This report also discussed the commonality of symptoms between hypogonadism and obesity, warning that many men who don’t actually require Testim may be exposing themselves to a risk of having a stroke. The outcomes of this research can be found in the January 2014 edition of PLoS ONE.

Undermining Testosterone’s Dangers, Advertising Boosts Prescriptions for Testim

Testosterone Stroke Warning

In the past two years, as the Testim stroke risk has become increasingly apparent through major scientific studies, drug makers have been ratcheting up their promotion of testosterone replacement therapy. Auxilum, the maker of Testim, and other pharmaceutical companies spent a total of $107.3 million on “Disease Awareness” campaigns for Low T during 2012 – seven times the amount spent the previous year. Marketers have employed the trendy name “Low T” to refer to a range of complaints related to aging. 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. The great expenditure pharmaceutical companies made suddenly in 2012 to advertise drugs like Testim may show testosterone producers were aware the drug had a limited profit window. The number of prescriptions issued has tripled since 2001; three million American men used the leading testosterone gel in 2012. The sales of testosterone replacement drugs amassed $2 billion on profits during 2012, and are projected to climb to $5 billion by 2017.

Some critics argue pharmaceutical companies have intentionally concealed or ignored the testosterone stroke link. In 2013, a group of researchers culled all the previous studies of testosterone stroke danger. Ultimately comparing the results of 169 papers on the stroke risk from Testim and other drugs, researchers concluded that studies funded by drug companies were less likely to find a testosterone stroke connection than those that were not funded by the industry. The following conclusion was published in BMC Medicine in April of 2013:

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

A group of individuals have already filed Testim stroke lawsuits. Testosterone stroke lawsuits have been filed by men and the families of men who suffered stroke while taking Testim, and allege that patients were not adequately warned of the known link between testosterone and stroke. Testim stroke lawsuits will likely grown in number as knowledge of the stroke risk becomes widespread.

National Agencies Issue Testosterone Stroke Warnings

Federal regulator were not the first or only group to issue a Testim stroke warning. The American Urological Society has issued a warning that Testim and other similar drugs are potential dangerous. Testosterone replacement therapy has been added to that organization’s list of overused and potentially harmful products. One major concern of both the American Urological Society and Consumer Reports, who have also issued a testosterone stroke warning, is that drugs like Testim are not effective at treating erectile dysfunction (ED). Taking Testim for ED needlessly exposes a man to the risk of stroke, and has not been proven to resolve the initial problem. Both Consumer Reports and the American Urological Society say the testosterone stroke risk often outweighs the benefits of Testim in many cases.

The public safety advocacy group Public Citizen filed a petition with the FDA in February of 2014, calling for a Black Box warning on Testim and other testosterone drugs to caution patients about the cardiovascular dangers of Testim. The drug’s label currently does not require a stroke warning.

Testim Stroke Lawyers Help Men and their Families

Testosterone Stroke Lawyer

Our attorneys handling testosterone lawsuits for men who have suffered from stroke, and the family members of persons who have suffered from Testim stroke, bring expertise to the task of standing up to the forces of billion dollar corporate enterprises. Leaving no stone unturned as they thoroughly prepare your case for trial, our Testim stroke attorneys are committed to fighting to the end to assure you get the compensation you deserve. If you or a loved one suffered from stroke while taking Testim, a member of our testosterone lawyer team will be happy to provide you with a free Testim claim evaluation.

Testosterone Stroke Lawsuits

Men and the family members of men who have suffered from one or more strokes or other cardiovascular problems while taking testosterone may have legal grounds to file a Testim 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.