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Testosterone Heart Attack Lawsuit Center

Testim Heart Attack Warning

WARNING: TESTIM USERS FACE RISK OF HEART ATTACK

Recent scientific research has shown that men who take Testim and other similar testosterone replacement drugs have a two to three times higher risk of heart attack than other men. Multiple studies conducted in recent years have added to researchers’ understanding of the testosterone heart attack risk. Doctors and safety experts criticize testosterone drug marketers for making unproven assertions about the product’s benefits while minimizing the testosterone heart attack danger.

Filing a testosterone lawsuit can bring about meaningful compensation for men who have suffered from Testim heart attack, and may also be the best method to demand corporate accountability for the injustices done to men who have suffered heart attacks while taking Testim. This section offers information on testosterone replacement therapy drug benefits and risks, outlines research on the Testim heart attack connection, and provides information about testosterone heart attack warning statements.

FDA Testim Heart Attack Warning

The Testosterone Heart Attack Connection

Testosterone replacement therapy (TRT) has been approved by the FDA as a treatment for hypogonadism, a diagnosable medical condition in which a man’s body produces little or no serum testosterone which can be accompanied by serious health problems. Hypogonadism can be congenital or acquired, and is different from the natural reduction of testosterone that is part of the aging process. Men over the age of 30 have, on average, a 1% loss of testosterone on an annual basis. Gradually diminishing testosterone levels are one aspect of andropause, which is the medical name for the natural aging process in men.

A gradual diminishment in testosterone is a normal part of aging and while it may effect changes it typically does lead to serious health problems. Hypogonadism, in comparison, is considered a medical condition and can result in major health complications. Symptoms of hypogonadism include a lack of muscle and body hair, low libido, and, in some cases, other severe medical complications. This true lack of serum testosterone can be cause by an inability of the testicles to produce testosterone as a result of genetics or chemotherapy, or a problem with the hypothalamus and pituitary portions of the brain that control hormone production. Testim and other similar products have only been tested and approved by the FDA to remedy genuine hypogonadism, a condition that must be diagnosed through blood testing. A significant portion of patients currently taking testosterone did not undergo blood testing as part of the diagnosis process.

Testosterone replacement therapies come in many different forms including topical gel, transdermal patch, buccal system (applied on the upper gums or inner cheek), and injection. The most popular by far is topical gel, including such products as Testim, AndroGel and Axiron. Numerous companies produce hormone replacement products; Testim is produced by Auxiulum Pharmaceuticals and has been on the market since it was approved for treating hypogonadism in 2002.

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

Rather than marketing Testim and similar drugs to treat hypogonadism, pharmaceutical companies have coined the term “Low T” to refer to a wide range of ailments that are a part of the normal male aging process. Critics accuse testosterone marketers of advertising Testim and similar drugs for uses that have never been scientifically proven. Over $100 million was spent on “Low-T Disease Awareness” campaigns in 2012, which encourage men to self-diagnose and request a testosterone prescription. Low-T quizzes ask questions that anyone can fail, such as Do you get tired after dinner? implying that men who feel sleepy in the evening are appropriate for taking testosterone. Advertising for Testim and similar products asserts that testosterone replacement can boost energy and libido, resolve erectile dysfunction (ED), enhance cognitive thinking, increase muscle mass and bone density, accelerate athletic performance, and aid in weight loss, among other claims. Researchers and doctors have pointed out that there is no solid evidence to support these uses of testosterone because no qualifying research has yet been conducted. These marketing campaigns rely on an assumption that more testosterone is good for men, and minimize the potential risks of introducing hormones not produced by the body. Doctors may legally prescribe drugs for any use they deem appropriate, but pharmaceutical marketing is legally required to advertise only for FDA-approved uses.

FDA Testim Heart Attack Warning Issued in 2014

Testosterone boosting products such as Testim have only been FDA-approved for use in treating medical complications caused by genuine hypogonadism. The drugs are used much more broadly, exposing millions of men to the risk of heart attack unnecessarily. The FDA has issued a testosterone heart attack warning, suggesting that the risk of heart attack associated with Testim and similar products outweighs the drug’s proven benefits.

The FDA Testim Heart Attack Warning was issued on January 31, 2014. Citing numerous recent studies, the FDA heart attack warning states that federal regulators have undertaken an investigation of the link between testosterone replacement drugs and heart attack, in addition to other health problems. At this time, the federal agency advises patients to keep taking the drug unless their doctor advises otherwise, but encourages medical practitioners to assess patients’ need for the drug carefully before prescribing. Federal regulators request that doctors and patients file adverse event reports to the MedWatch program in order to collect information about testosterone heart attack.

How Testim Increases a Man’s Risk for Heart Attack

Testim Heart Attack Lawyer Testosterone replacement therapy is through to increase a person’s chance of heart attack because of its effect on red blood cell production. Boosting the number of red blood cells is thought to increase the risk of heart problems. Red blood cells have a tendency to clump together or coagulate, so an abundance of them can thicken the blood. Testim heart attacks and other heart complications are thought to originate from this thickening of the blood.

The fact that testosterone replacement therapy causes medical problems is no surprise to endocrinologists; hormone replacement in general is known to be risky. At one point, estrogen replacement therapy became a popular remedy for women during menopause. The overprescribing of estrogen replacement therapy for women was eventually curtailed when research showed that estrogen replacement is associated with a higher risk of heart attack, breast cancer and stroke. Clinicians now use estrogen sparingly and only in extreme cases for which it is indicated and the benefits outweigh the risks. Some critics of men’s hormone replacement drugs like Testim predict that testosterone will follow a similar course as word of the testosterone heart attack risk spreads.

Testim Heart Attack Research

The first clear connection between testosterone and heart attacks was revealed in 2010, when researchers at Boston University’s School of Medicine chose to end a small study prematurely because so many study subjects were having heart attacks from taking Testim. The study, which can be found in the New England Journal of Medicine, indicated that men taking testosterone products were five times as likely to have heart attacks or another “serious heart event” as men not taking the supplemental hormone.

The FDA testosterone heart attack warning referred to two recent studies which confirm a link between testosterone products like Testim and heart attack. Research conducted through the Veterans Affairs health service examined 8,709 men through a type of heart imaging called coronary angiography and determined that taking supplemental testosterone increases the risk of heart attack, stroke and death by 29%. Subjects in this study ranged in age broadly, with an average age of 60 years old. This study was published by JAMA (the Journal of the American Medical Association) in November of 2013.

A second study cited in the FDA Testim warning included 56,000 subjects also ranging broadly in age. These men were examined for their initial 90 days taking testosterone replacement products. This study concluded that men face a two- to three-fold increase in their risk for heart attack immediately after starting a prescription for Testim; the level of risk generally grows as a man ages, but can also be connected to other factors. Noting that the symptoms of hypogonadism and obesity are similar, researchers suggested that many obese men are being prescribed testosterone who do not need the drug – and thus are being exposed to the risk of heart attack unnecessarily. This testosterone heart attack study was funded by the National Institutes of Health, conducted by a group of endocrinologists and endocrine research experts in California, and published by PLoS ONE in January of 2014.

Testim Advertising Minimizes Testosterone Heart Attack Risk and Prescriptions Increase

As Testim heart attack evidence has surfaced, Auxilium and other pharmaceutical companies selling similar testosterone products have poured significant resources into Low-T advertising, spending $107.3 million in advertising in 2012 (compared to $14.3 million in 2011) to promote testosterone replacement for men. This surge in advertising suggests manufacturers of testosterone drugs like Testim perceived a window of opportunity to profit from testosterone replacement drugs. Three times as many men were taking testosterone in 2013 as were taking the drug in 2001. In 2012, 3 million prescriptions were written for AndroGel, the most popular of these drugs. Drug companies pulled in $2 billion in profits during 2012, and if the current trend continues, testosterone drug sales will reach $5 billion by 2017.

Some critics argue that the testosterone heart attack risk has been downplayed or concealed intentionally by pharmaceutical companies. A large meta-analysis published by BMC Medicine in April of 2013 examined 169 papers on testosterone heart attacks. This review found that researched backed by pharmaceutical companies was less likely to correlate testosterone and heart attack than research funded by other sources:

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

Some testosterone lawsuits have already been filed on behalf of men who suffered from heart attacks while taking testosterone. Testim heart attack lawsuits allege that Auxilium failed to adequately warn consumers of the heart attack risk associated with hormone replacement. Pharmaceutical companies that sell testosterone replacement drugs anticipate a growing number of testoterone heart attack lawsuits now that the testosterone heart attack risk has been acknowledged by the FDA.

Numerous Agencies Issue Testosterone Heart Attack Warnings

Consumer Reports has issued a warning on the link between heart attack and testosterone therapy. Dr. John Santa, quoted in the Consumer Reports testosterone heart attack warning, believes many men are using Testim and similar drugs without a medical need, but may be unaware of the potential side effects of the drug. Citing side effects that include heart attack and other serious heart problems, Consumer Reports reminds consumers that testosterone therapy has only been proven to remedy hypogonadism and has not been proven for treating many other symptoms for which it is prescribed. In particular, this Testim heart attack warning notes the treatment has not been approved for or shown to resolve erectile dysfunction (ED), and warns that men taking Testim or similar drugs for ED may be exposing themselves to heart attack risks unnecessarily. The American Urological Society listed testosterone therapy among the most common overused and misused treatments, stating that Testim is not a proven treatment for erectile dysfunction and noting that male hormone treatment can cause a range of serious health problems like heart attack.

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 heart attack warning.

Testim Heart Attack Lawyer Group Helps Men and their Families

Our testosterone attorneys handling Testim heart attack lawsuits on behalf of men and their family members who suffered from a heart attack while taking Testim are pharmaceutical safety litigation experts. When a family is harmed or loses a loved one as a result of injustice, our testosterone lawyers believe justice and corporate accountability must be pursued. They will work tirelessly on your behalf to assure you get the compensation you deserve. If you or your father, spouse, or other loved one suffered from a heart attack and while taking testosterone, a Testim heart attack attorney can help by answering your questions and giving you a sense of your legal options.

Testosterone Heart Attack Lawsuits

Men who suffered one or more heart attacks while taking Testim may have grounds for a Testim heart attack lawsuit. We provide legal representation for testosterone heart attack lawsuits on a contingency basis: our testosterone attorneys charge no fee unless we win compensation on your behalf.