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Low-T Testosterone Heart Risk Lawsuit
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Men who take testosterone drugs are at increased risk of testosterone stroke and testosterone heart attack , according to recent studies. One testosterone drug, Androgel, warns on its label a number of testosterone side effects including high blood pressure, blood clots in the legs, and “serious problems” for people who have heart, kidney or liver disease. Other low-t treatment brand names include Androderm, Axirom, Bio-T-Gel, Delatestryl, Depo-Testosterone, Fortesta, Striant, Testim and Testope. Men who have suffered such side effects are filing testosterone lawsuits.
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The following studies have linked testosterone to testosterone heart risks.
Low-T Testosterone Therapy Risks
October 2014: Men who have low testosterone and Type 2 diabetes face a greater risk of developing atherosclerosis – a condition where plaque builds up in the arteries – than men who have diabetes and normal testosterone levels, according to the Endocrine Society's Journal of Clinical Endocrinology & Metabolism. Authors of the study, titled “Low Testosterone Concentration and Atherosclerotic Disease Markers in Male Patients with Type 2 Diabetes,” recommend that testosterone treatment should be reserved for men with clinical symptoms of hypogonadism and consistently low levels of testosterone. The Society also has called for large-scale, well-controlled trials to assess the long-term cardiovascular risks associated with testosterone therapy.
January 2014: A study titled Testosterone Therapy and Myocardial Infarction (January 2014) published by the Public Library of Science in conjunction with the University of Florida and the National Cancer Institute shows an association between testosterone therapy (TT) and cardiovascular disease. The researchers also noted that testosterone therapy is increasing despite the fact that in older men, and in younger men with pre-existing diagnosed heart disease, the risk of myocardial infarction shortly after they begin testosterone therapy is substantially increased.
The PLOS ONE study reported that increased risk of heart attack among young men with prior heart disease is a “particular public health concern, as about 10 percent of the men in our study under age 65 years with a [testosterone therapy] prescription had a history of heart disease.”
November 2013: The Journal of the American Medical Association also associated cardiovascular risk with testosterone therapy. Researchers said the study warranted cautious testosterone prescribing and additional investigation. (See JAMA video)
While a number of studies have shown that treating low testosterone can improve men's sexual function, bone density, strength and lean muscle mass and at the same time lower cholesterol and insulin resistance, the recent JAMA study indicates that the risks outweigh the benefits. Researchers reported that men who used testosterone were 30 percent more likely to have a heart attack or stroke or to die during a three-year period than men with low hormone levels who didn't take the supplements. The study’s 3,000 participants averaged 60 years of age and most of the men (hormone users and non-users) had other health problems including high blood pressure, unhealthy cholesterol and diabetes.
Testosterone Heart Attack Studies
Further, participants who began the study with clear, unobstructed coronary arteries were just as likely to have a heart attack, stroke, or die as men who entered the study with established coronary artery disease.
Researchers in 2009 discontinued a trial of about 200 frail older men with a high prevalence of heart disease due to a high rate of heart attacks among those taking testosterone. The trial was funded by the National Institutes of Health. According to The Wall Street Journal (Nov 5, 2013) another study sponsored by the Institute is studying the effects of testosterone on walking ability, fatigue, sexual function, verbal memory, hemoglobin and plaque buildup of nearly 800 men aged 65 and older with low testosterone. The results won’t be available for at least a year.
Interestingly, studies funded by pharmaceutical companies have concluded there is no increased risk of adverse cardiovascular events associated with testosterone drugs such as AndroGel.
AndroGel 1% and AndroGel 1.62% are both prescription products used for daily testosterone replacement therapy (TRT). They are manufactured by AbbVie (formerly part of Abbott Labs). The gel is applied to the skin of the shoulders and upper arms.
Androgel Testosterone Black Box Warning
Secondary exposure to testosterone in children and women can occur with the use of testosterone gel in men. Cases of secondary exposure to testosterone have been reported in children. Consequently the FDA placed a black box warning about the risks of AndroGel 1% to children and women in September 2009.
In June, 2014, the U.S. Judicial Panel on Multidistrict Litigation ordered the consolidation of all federal litigation over testosterone replacement therapies in the Northern District of Illinois.
Five Androgel lawsuits were filed on February 4, 2014 in Illinois federal court against the manufacturers AbbVie Inc., and Abbott Laboratories, Inc., claiming the manufacturers concealed facts about the serious side effects associated with the drug.
The first of what is expected to be many testosterone therapy treatment lawsuits. (1:14-cv-772), was filed in the US District Court for the Northern District of Illinois Eastern Division by plaintiff Kenneth Aurecchia, who claims he suffered a heart attack due to the drug. He also alleges other physical and emotional damage after taking Androgel for what he believed were symptoms of low testosterone after watching commercials for the product.
A testosterone lawsuit filed September 2014 in federal court in Newark claims Eli Lilly, the maker of Axiron, put users at risk by aggressively marketing its testosterone replacement drug while failing to adequately warn about the risk of heart attack and stroke.
Plaintiff Patrick Miller, age 56, started taking Axiron in September of 2012 and suffered a heart attack about one month later. The Axiron lawsuit says that Miller's doctor would not have prescribed Axiron if he had been warned of the increased risks of heart problems caused by using the drug.
The lawsuit further alleges that Lilly markets Axiron to men by describing "symptoms" of "Low T," such as decreased sexual desire, erectile dysfunction, fatigue and loss of energy, that are caused by a "non-existent and unrecognized medical condition called Low T," Rather, those symptoms naturally occur as a result of the aging process.
Miller's lawsuit accuses Lilly of failure to warn, defective design, defective manufacturing, negligence, breach of implied warranty, breach of express warranty, fraud and negligent misrepresentation. The Axiron testosterone lawsuit seeks compensatory and punitive damages, and more.
More than 5 million prescriptions for testosterone therapy were written in the US in 2011—with sales of almost $2 billion. Treatment can be delivered as a gel (such as Androgel), cream, patch or pill, injection or implant. Along with Androgel, the following brand names designed to treat low-t also qualify for a potential class action lawsuit:
Other Testosterone Treatments
Android: generic name Methyltestosterone, is a man-made form of testosterone. Each capsule contains 10 mg of MethylTESTOSTERone USP.
Androxy generic name Fluoxymesterone, is an androgen. It is taken orally and is frequently misused for its muscle-enhancing effects.
Axiron: A topical solution to treat low-t that is made by Eli Lilly and was approved in 2010. Axiron is applied to the armpits in a manner similar to deodorant.
Bio-T Gel: A once-daily testosterone treatment gel made by GlaxoSmithKline was approved in February 2012, but is rarely prescribed.
Delatestryl: (Testosterone Enanthate, brand names Delatestryl, Tesamone) A testosterone injection treatment or intramuscular agent made by Savient Pharmaceuticals. Approved in 2003, it is injected into the buttock muscle usually every 1 to 4 weeks. Among a list of side effects it warns” Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (such as heart failure, chest pain, heart attack).
Depo-Testosterone: (testosterone cypionate) is an intramuscular agent for low testosterone (low-t) introduced by Pfizer in 2003, and available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate. On its website Pfizer states that Depo-Testosterone has been “used for more than 30 years in the treatment of males with low testosterone”. Sun Pharmaceutical Industries received approval from the FDA in June 2103 for its Abbreviated New Drug Application (ANDA) for generic version of depo-testosterone injection, testosterone cypionate injection USP, 100 mg/ml and 200mg/ml.
DHEA (Dehydroepiandrosterone) is a hormone produced by the body’s adrenal glands. DHEA is banned by the NCAA. Taken in tablet form, it is marketed to increase sexual function and build body mass.
First-Testosterone:(testosterone topical) is sold in cream form and First-Testosterone MC is sold as a gel, which is absorbed by the skin.
Fortesta: A testosterone spray gel that is applied to front and inner thighs daily. Fortesta is made by Endo Pharmaceuticals and approved in December 2010 as a Class III product for topical use for men with low testosterone. Endo warns that “Safety and efficacy of Fortesta Gel in males less than 18 years old have not been established.” Endo also warns that its product “can transfer from your body to others… Women and children should avoid contact with the unwashed or unclothed areas where Fortesta Gel has been applied.”
Methitest:(Methyltestosterone) is an androgen. The 10mg tablet is taken orally, from 1-4 times per day. It is packaged by Global Pharmaceuticals, Division of Impax Laboratories Inc.
Striant: (generic: testosterone buccal system), is a tablet containing 30 mg of testosterone that slowly releases testosterone into the mucous membranes of the mouth. Made by Columbia Laboratories Inc. and approved by the FDA in Jun 2003, it was purchased by Auxilium Pharmaceuticals in April 2011.
Teslac:: (generic name Testolactone) blocks the production of the hormone estrogen and is used to treat some types of breast cancer. It is no longer available in the US.
Testim: A widely used gel treatment for testosterone replacement that is applied to the shoulders daily. It was approved in October 2002 and made by Auxilium.
Testopel: Made by Slate Pharamceuticals, a testosterone implant containing approximately 75mg of testosterone is placed under the skin, releasing the hormone over a period of 3 to 6 months after insertion. Testopel was developed in the early 1970s but not approved by the FDA until 2008.
Testopel Pellets: About the width of a dime, pellets are implanted subcutaneously under the skin in an approximately 15-minute procedure. Pellets typically last for 3 to 4 months and up to 6 months per dose.
Testred Methyltestosterone: capsules, along with prescribed as testosterone therapy, is also be used in certain adolescent boys to trigger puberty in those with delayed puberty.
Canadian Brand Names:
Andriol: comes in a soft gelatin capsule marked "ORG DV3" and contains 40 mg of testosterone undecanoate.
Androplex:, the same brand name as Androderm in the US, is a testosterone transdermal patch.
Attorneys are seeing an increase in claims from men using low-T treatments or testosterone therapy. This increase is mainly due to aggressive direct-to-consumer advertising by the manufacturers of testosterone supplements and drugs. Doctors are prescribing testosterone treatment off-label to help men fight their natural decline in testosterone as they age and allegedly build muscle mass, strengthen bone density and improve sex drive. Off-label marketing of testosterone supplements and drugs is illegal.
Testosterone Off-Label Marketing Lawsuit
Testosterone manufacturers such as AbbVie aggressively market its testosterone drug by telling men the following: “If you're bored, stressed or aging normally, you probably have Low T symptoms: grumpiness, less energy, lower libido and "falling asleep after dinner." These “symptoms” are also associated with the natural process of aging.
In 2000 the FDA told AbbVie that “claims and representation that suggest that AndroGel is indicated for men with ‘age-associated’ hypogonadism or ‘andropause’ are misleading.” The agency said that AndroGel was only approved for men with hypogonadism—a condition in which the body doesn't produce enough testosterone.
In 2003 a lawsuit was filed against Solvay Pharmaceuticals Inc. (which was later bought by Abbott Laboratories) alleging False Claims Act violations, The whistleblower suit ( King et al. v. Solvay SA et al., case number 4:06-cv-02662, in the U.S. District Court for the Southern District of Texas) claims that off-label promotion resulted in millions of dollars worth of false claims submitted to government health care plans by pharmacies who filled the prescriptions of the drugs.
Further, in order to boost sales, Solvay allegedly conspired with doctors to prescribe off-label uses of the drugs and paid unlawful kickbacks to doctors who prescribed the drugs in the form of "bogus speaker and research fees, resort weekends, cash payments, or Harley-Davidson goods”.
The lawsuit includes a leaked document by Solvay discussing the need to expand the testosterone market by 36.5 percent, according to a McClatchy Newspapers article. According to the article, Solvay talked about pushing the drug to primary care physicians, described as “easily influenced.” A 2004 memo on AndroGel sales strategies said the sales force was putting extra emphasis on rural areas, since “rural doctors are typically very accessible, give us plenty of time to teach them the right way to diagnose and treat, and they have the patients.”
A further document that was disclosed in a lawsuit against Solvay, then the maker of Androgel, discussed a need to expand the testosterone market by 36.5 percent, according to a McClatchy Newspapers article.
AbbVie, Inc., in response to the study, said that testosterone treatments are approved by the FDA, and the risks are listed. As noted above, the FDA has only approved testosterone drugs to men who have been diagnosed with low testosterone levels.
According to Abbott, AndroGel annual US sales are more than $600 million.
Testosterone therapy studies raise concerns about testosterone supplements that men should discuss with their doctors. Health professionals advise that patients should not discontinue testosterone treatment without first consulting their physician.
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Last updated on Nov-19-14
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