Low-T Testosterone Heart Risk Lawsuit

From the Journal of the American Medical Association.

Men who take testosterone drugs are at increased risk of testosterone stroke and testosterone heart attack , according to a recent study. 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.
Attorneys are seeing an increase in claims from men while using low-T treatments or testosterone therapy in the wake of this study, published in the Journal of the American Medical Association (November 2013), which has linked the hormone to serious side effects, including testosterone death.

Testosterone therapy, which is only approved by the FDA to treat men with a diagnosis of low testosterone levels, has increased to 432 million prescriptions, including refills sold in 2013, from 208 million in 2008. During the period 2000 to 2011, annual prescriptions for testosterone increased more than five-fold. In 2011, the total number of prescriptions numbered 5.3 million equaling a market of $1.6 billion.

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.

Prior to this study, doctors were unaware of the risks involved. Dr Michael Ho, a cardiologist at the VA Eastern Colorado Health Care System and senior author of the study, said they “didn’t know much about the cardiovascular risk” and advises men to ask themselves if the risks outweigh the benefits. Other doctors are asking for additional safety testing to ensure that patients are aware of the risks that they are taking.

Testosterone Heart Attack Studies

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.

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 Testosterone Black Box Warning

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.

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.

Androgel Lawsuit

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.

Other Testosterone Treatments

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:

AndroDerm: A testosterone patch or transdermal film now made by Actavis, Inc. (formerly Watson Pharmaceuticals), Androderm is a transdermal system that delivers testosterone supplementation through skin in the back, abdomen, thighs, or arms. The product is available in two strengths that deliver 2 or 4 mg of testosterone to the user per day. Androderm was approved by the FDA in 1995.

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.

Foresta: A testosterone spray gel that is applied to front and inner thighs daily. Foresta 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 Foresta 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 Foresta Gel has been applied.”

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.

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.

Manufacturers of the above testosterone treatments have been accused of placing profits before the safety and health of consumers by:

Failing to adequately research the risk of stroke or heart attack from testosterone therapy, especially among men with cardiovascular disease, high cholesterol, blocked arteries, diabetes, obesity and other prior heart problems.

Recklessly marketing testosterone treatments in direct-to-consumer advertisements that encourage otherwise health men to seek prescription medications for “Low T” if they are experiencing any number of general symptoms, such as lack of energy, weight gain, decreased sex drive and other natural issues experienced by men as they age.

Testosterone Off-Label Marketing

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 Side Effects

Other testosterone drugs are also associated with more heart attacks, blood clots and anemia, worsening heart failure, and increased prostate cancer risk. The following drugs also treat low testosterone:

Androderm
Axirom
Bio-T-Gel
Delatestryl
Depo-Testosterone
Fortesta
Striant
Testim
Testope

Researchers say the 2013 JAMA study raises definite concerns about testosterone supplements that men should discuss with their doctors. Users of testosterone replacement drugs with concerns should contact their doctors. Patients should not discontinue testosterone treatment without first consulting their physician.

May 1, 2014.

Editor: Although the publication date of an article may not be current the information is still valid.