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AndroGel Heart Attack Warning

WARNING: HEART ATTACK CAUSED BY ANDROGEL AND OTHER TESTOSTERONE THERAPIES

AndroGel and other similar testosterone replacement products have been linked to a two- to three-fold increase in the risk of heart attack for men. Numerous studies published in recent years have contributed to researchers’ understanding of the testosterone heart attack risk. Advertising for drugs such as AndroGel is criticized for making false claims about the product’s efficacy while glossing over the dangers of heart attack.

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

FDA AndroGel Heart Attack Warning

FDA AndroGel Warning for Heart Attack

The FDA has only approved the use of testosterone products for medical complications caused by genuine hypogonadism. Today, many clinicians and researchers warn against the broad use of AndroGel because of the risk of heart attack. The FDA has issued a testosterone heart attack warning, suggesting that the risk of heart attack associated with AndroGel and similar products outweighs the drug’s proven benefits.

The FDA AndroGel 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. While the FDA testosterone warning recommends that patients continue taking the drug until consulting with their care providers, doctors are cautioned to weigh the pros and cons of the drug before prescribing it. Additionally, the FDA AndroGel warning encourages clinicians and patients to make reports to the FDA’s MedWatch program to contribute to the body of knowledge on testosterone heart attack and death risks.

Understanding the Science behind the AndroGel Heart Attack Risk

The heart attack risk is traced to the fact that testosterone supplementation increases red blood cell production. Red blood cells can clump together or coagulate, so an abundance of them can thicken the blood. AndroGel heart attacks and other cardiovascular problems are thought to originate from this thickening of the blood.

Hormone replacement therapies have a history of causing medical complications. For a time, estrogen replacement therapy was thought to resolve a range of symptoms of menopause in women, and a rash of prescribing took place. The overprescribing of estrogen replacement therapy was reined in by findings that hormone replacement in women increases the risk of heart attack, breast cancer and stroke. Today, estrogen is used sparingly and only in extreme cases. Experts speculate that as the testosterone heart attack risk becomes public knowledge, the number of prescribers will nosedive.

AndroGel Heart Attack Research

Research specifically indicating a link between testosterone and heart attacks first emerged in 2010, when a small study conducted at Boston University’s School of Medicine (and later published by the New England Journal of Medicine) was forced to end early due to exceptionally high heart attack rates for subjects taking Testim 1%. The findings from that research suggested 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.

AndroGel Heart Attack RiskThe two notable AndroGel heart attack studies that directly resulted in the FDA warning are very recent. Research conducted through the Veterans Affairs health service examined 8,709 men through a type of heart imaging called coronary angiography and found that taking supplemental testosterone increases the risk of heart attack, stroke and death by 29%. The average age of men involved in this study was 60 years old. This study was published by JAMA (the Journal of the American Medical Association) in November of 2013.

The second study cited in the FDA AndroGel warning examined 56,000 middle aged and older men for their first 90 days taking testosterone replacement products. This study concluded that men taking AndroGel face a two- to three-fold risk for heart attack, depending on their age, immediately after starting the prescription. Citing a tendency for hypogonadism and obesity to present with identical symptoms, researchers suggested that many men are being prescribed with testosterone drugs unnecessarily, meaning that many men are facing the risk of heart attack unnecessarily. This most recent AndroGel heart attack research 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.

Low T and the Testosterone Heart Attack Connection

Testosterone replacement therapy (TRT) is a hormone replacement method for men suffering from hypogonadism, a medical condition in which a man’s body produces little or no serum testosterone. Hypogonadism can be congenital or acquired; in fact, a decline in testosterone is a natural part of aging. Men over the age of 30 have, on average, a 1% loss of testosterone on an annual basis. The natural decline of testosterone is one aspect of andropause, a term that refers to the male aging process.

While small declines in testosterone are normal and typically don’t cause severe medical conditions, hypogonadism is an endocrine disorder characterized by a lack of muscle and body hair, low libido, and sometimes more severe medical complications. Hypogonadism can be caused by varying medical conditions, including 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. AndroGel and other similar products are approved to treat genuine hypogonadism only, which must be diagnosed through blood testing.

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 hormone replacement 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

Drug companies have adopted the name “Low T” to refer to hypogonadism; Low T has become a catch-all phrase for a range of ailments facing aging men. Critics assert that aggressive advertising campaigns launched by AbbVie and other companies, misleadingly labeled as “Disease Awareness” campaigns feature broad and general questionnaires that anyone can fail, resulting in a huge number of men self-diagnosing for Low T. These advertising campaigns suggest that products like AndroGel can be used to increase energy, boost libido, resolve erectile dysfunction (ED), improve cognitive thinking, build muscle mass and bone density, enhance athletic performance, and shed extra weight, among other claims. Due to a lack of research on the topic, no one knows if testosterone products really can achieve each of these claims.

AndroGel Marketing Downplays Testosterone Heart Attack Risk; Prescriptions Swell

Testosterone Heart AttackDespite the emergence of AndroGel heart attack evidence in recent years, AbbVie and other producers of testosterone products have $107.3 million in advertising in 2012 (compared to $14.3 million in 2011) to promote hormone replacement therapies to aging men suggesting it will help them feel youthful. This surge in advertising suggests manufacturers of AndroGel and similar products saw a huge profit opportunity in testosterone. The number of prescriptions issued for testosterone 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.

Some evidence suggests the testosterone heart attack risk has been covered up or ignored on purpose within the pharmaceutical industry. A large meta-analysis published by BMC Medicine in April of 2013 examined 169 papers on the topic. This review found that studies funded by pharmaceutical companies were less likely to detect a heart attack connection than those without a conflict of interest:

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

Some men who have suffered from heart attacks have already filed testosterone lawsuits, alleging that AbbVie failed to adequately warn consumers of the heart attack risk. Testosterone heart attack lawsuits are expected to grow in number as the heart attack risk becomes public knowledge.

Consumer Reports Testosterone Heart Attack Warning

Consumer Reports warns men of the dangers of testosterone. Dr. John Santa, quoted in the Consumer Reports testosterone heart attack warning, believes many men are using AndroGel and other comparable products unnecessarily and that most men don’t need hormone replacement therapy. Citing side effects that include heart attack and other cardiovascular events, Consumer Reports reminds consumers that testosterone therapy is not necessarily effective. In particular, this AndroGel heart attack warning notes the treatment 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 AndroGel is not useful for treating erectile dysfunction, and noting that male hormone treatment is accompanied by too many severe risks such as heart attack.

AndroGel Heart Attack Lawyers Help Men and their Families

Our attorneys handling testosterone heart attack lawsuits on behalf of men and their family members who suffered from a heart attack while taking AndroGel or another comparable product are drug safety litigation experts. 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 took testosterone, an AndroGel 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 and have taken AndroGel may have grounds for an AndroGel heart attack lawsuit. We provide legal representation for testosterone heart attack lawsuits on contingency basis, meaning that we charge no fee unless we win compensation on your behalf.