On Tuesday March 3rd, the United States Food and Drug Administration required that manufacturers of testosterone supplements (or, Low-T drugs)  include warnings on packaging for the increased risk for heart attack and stroke linked to these drugs.

In years past, a great many peer-reviewed scientific studies had demonstrated that men using Low-T drugs were at dramatically higher risk for heart attack and stroke.  Finally, this work has led the FDA to require a warning label update.

Further, labels for Low-T drugs are now required to include warnings that the medication is approved only for men with specific medical ailments.  The popularity of Low-T drugs has soared in recent years, and many men never actually have testosterone levels checked before getting a prescription.  In this way, huge numbers of men use Low-T drugs to treat “symptoms” of normal aging, placing themselves at high risk for cardiac event without informed consent.

Reuters reported yesterday that “The number of men being prescribed testosterone jumped more than 75 percent, to 2.3 million, between 2009 and 2013” and “About 70 percent of these patients were between the ages of 40 and 64, the FDA said.”

Importantly, that report noted this FDA ruling about Low-T drugs “restricts companies from marketing or promoting their products for age-related low testosterone.”

Annual sales for Low-T drugs topped $2 billion last year, and AndroGel – a popular testosterone-infused gel by Abbvie and Abbott Laboratories – took in over $900 million in sales.

For more information on Low-T drugs and their link to both heart attack and stroke, click here.

Because many men used these drugs unaware of the risks associated, many Low-T lawsuits are currently being filed.  If you or a loved one used a Low-T drug and suffered an adverse cardiac event, you may be entitled to significant financial compensation.  For a free consultation, contact our team of testosterone lawyers today.  Or, find information on Low-T lawsuits here.

(855) 452-5529

justinian@dangerousdrugs.us

 

Here is the FDA Drug Safety Communication for Low-T:

“[This information is an update to the FDA Drug Safety Communication: FDA Evaluating Risk of Stroke, Heart Attack, and Death with FDA-Approved Testosterone Products issued on January 31, 2014.]

[Posted 03/03/2015]

AUDIENCE: Health Professional, Endocrinology, Urology, Family Practice, Patient

ISSUE: FDA is requiring that the manufacturers of all approved prescription testosterone products change their labeling to clarify the approved uses of these medications. FDA is also requiring these manufacturers to add information to the labeling about a possible increased risk of heart attacks and strokes in patients taking testosterone. FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.

Based on the available evidence from studies and expert input from an FDA Advisory Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not. See the Data Summary section of the FDA Drug Safety Communication for additional details.

BACKGROUND: Testosterone is FDA-approved as replacement therapy only for men who have low testosterone levels due to disorders of the testicles, pituitary gland, orbrain that cause hypogonadism. However, FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established.

RECOMMENDATION: Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. Health care professionals should make patients aware of the possible increased cardiovascular risk when deciding whether to start or continue a patient on testosterone therapy. Patients using testosterone should seek medical attention immediately if symptoms of a heart attack or stroke are present, such as chest pain, shortness of breath or trouble breathing, weakness in one part or one side of the body, or slurred speech.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[03/03/2015 – Drug Safety Communication – FDA]”

Previous MedWatch Alert:

[01/31/2014 – Drug Safety Communication – FDA]

According to a recent article published in Current Opinion in Endocrinology, Diabetes, and Obesity by CM Schooling titled “Testosterone and cardiovascular disease.”,  there is a clear link between use of testosterone supplements such as AndroGel and increased risk for heart attack.

Schooling (2014) writes, “Use of testosterone among men is increasing rapidly. Low serum testosterone is positively associated with cardiovascular disease and its risk factors” and explains that the article aims to review current literature regarding testosterone and adverse cardiac event.

“In a large, well conducted pharmacoepidemiology study specifically testosterone prescription was associated with myocardial infarction.”  (For clarity, “myocardial infarction” means heart attack.)

“A comprehensive meta-analysis of RCTs summarizing 27 trials including 2994 men found increased risk of cardiovascular-related events on testosterone (odds ratio 1.54, 95% confidence interval 1.09-2.18).”  This means that men using testosterone therapy products such as AndroGel are 54% more likely to suffer  “cardiovascular-related events” than non-users.

Because the manufacturers of AndroGel (AbbVie, Inc., Abbott Laboratories, Inc.) have failed time and again to adequately warn users of the risk for heart attack, stroke, and other adverse cardiac events, a number of AndroGel lawsuits are currently being filed.  If you or someone you know used AndroGel and suffered a heart attack or other cardiovascular side effect, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of AndroGel lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our AndroGel Lawsuit Information page is a great place to start if you have any questions about AndroGel.

In recent years, several important studies have shown that testosterone therapy is associated with an increased risk for heart attack, stroke, and even death, especially in older men.  Mainly, these studies have proposed, but not detailed, the biochemical mechanism by which increases in testosterone levels may pose these such risks, and this was not their aim.  Those studies, including the Vigen et al. (2013) report in Journal of the American Medical Association, the Finkel et al. (2014) report in PLoS One, and the  Xu et al. (2013) report in BMC Medicine, work to frame further research: we must first know that testosterone is linked to adverse cardiac events before we may determine how.

Scientists and doctors have found that testosterone therapy increases hemoglobin and hematocrit levels in the blood.  Hemoglobin is an iron-containing molecule in red blood cells that carries oxygen throughout the body, and hematocrit is the percent (by volume) of red blood cells in the blood.

Erythrocytosis, an elevation in red blood cell count, constitutes a serious clinical problem, and if a case becomes one of polycythaemia (highly elevated red blood cell count), can lead to thrombosis (blood clot) which in turn may cause heart attack or stroke. 

In 2013, Guo et al. published results of a study that aimed to determine how testosterone stimulates the production of red blood cells (“erythropoiesis”).  To do this, the team studied the process in mice, and concluded “testosterone inhibits hepcidin transcription through its interaction with BMP/Smad signaling” and that “Testosterone administration is associated with increased iron incorporation into red blood cells.”  To be clear, hepcidin is a hormone that regulates iron levels in the blood.  Without (as much) hepcidin, iron levels in the blood rise; more testosterone leads to more hemoglobin.

In 2014, Bachman et al. confirmed these results using human subjects and a double-blind, randomized placebo-controlled trial in which patients were given either testosterone gel or a placebo drug.  Results showed 7% increase in hemoglobin and 10% increased hematocrit levels among patients in the testosterone therapy group.  Unfortunately, the study stopped prematurely due to an increased rate of adverse cardiovascular events among study patients.

Further, a number of studies have demonstrated that a high hematocrit level is an independent risk factor for stroke.  The normal hematocrit level is between 40.7-50.3% for males.  The study found by following the above hyperlink determined that men whose hematocrit level is above 51% face a risk for stroke increased by more than 2.5 times.  With the Bachman 2014 study finding an increase in hematocrit levels of 10%, normal men using testosterone therapy may easily fall well above the normal range and face excess risk.  Another study showed that men with hematocrit levels above 46% faced a 1.5-fold increased risk for blood clot.  One proposed reason for this is that elevated hematocrit levels increase blood viscosity, thus raising the risk for thrombosis and stroke.

Another study, dubbed “The Framingham Study” linked high hematocrit levels with an increased risk for cardiovascular disease, myocardial infarction, angina pectoris, stroke, and Ischemic cardiomyopathy.

Testosterone Therapy Lawsuits

Due to the fact that the manufacturers of testosterone therapy products, such as AndroGel, have time and again failed to warn users of the risk for adverse cardiac events, stroke, and death, a number of AndroGel testosterone therapy lawsuits have been filed.  If you or a loved one used AndroGel and suffered one of the above-listed side effects, you may be entitled to significant financial compensation.

For a free, no-obligation case consultation, contact our team of AndroGel lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our AndroGel Lawsuit Information page is a great place to start if you have any questions about AndroGel.

 

In 2010, a study was published in The New England Journal of Medicine titled “Adverse events associated with testosterone administration.” by S. Basaria and a team of researchers, aiming to further clarify adverse events associated with testosterone therapy.  Currently, testosterone therapy is provided in the treatment of “Low-T” and other ailments, many in the medical field believe that testosterone is overprescribed.  Further, studies have shown that testosterone is associated with an increased risk for cardiac arrest, stroke, and death, especially in older men.

Studying a group of men older than 65 with low testosterone, Basaria administered either a placebo topical “testosterone” gel or real testosterone topical gel such as Androgel to this cohort, and closely observed the group for six months.

At the end of the observation period, 209 men remained in the study.  The research team writes “During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events”, findings consistent with the results of other studies on the association between adverse cardiac events and testosterone therapy, but from an admittedly small sample size.

As such, the team writes “In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy.”

However, the manufacturers of AndroGel (AbbVie, Inc., Abbott Laboratories, Inc.), a popular topical testosterone gel, have failed time and again to warn users of this risk.  As a result, a number of AndroGel testosterone lawsuits are currently being filed.  If you or a loved one used AndroGel and suffered an adverse cardiac event, stroke, or death as a result, you may be entitled to significant financial compensation.

For a free, no-obligation case consultation, contact our team of AndroGel lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our AndroGel Lawsuit Information page is a great place to start if you have any questions about AndroGel.

In the April, 2013 edition of BMC Medicine, L. Xu et al. published the results of a study titled “Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials.”.  This study sought to assess the relative safety of testosterone therapy with respect to adverse cardiac events.  The research team writes “Testosterone therapy is increasingly promoted” and notes “No randomized placebo-controlled trial has been implemented to assess the effect of testosterone therapy on cardiovascular events, although very high levels of androgens are thought to promote cardiovascular disease.”

To perform this meta-analysis, Xu et al. (2013) reviewed previously-published randomized controlled studies involving testosterone administration and used statistics to normalize the results.  “Of 1,882 studies identified 27 trials were eligible including 2,994, mainly older, men who experienced 180 cardiovascular-related events.”  Overall, results showed that “Testosterone therapy increased the risk of a cardiovascular-related event” by 54%.

Importantly, this study also revealed that “In trials not funded by the pharmaceutical industry the risk of a cardiovascular-related event on testosterone therapy was greater (OR 2.06, 95% CI 1.34 to 3.17) than in pharmaceutical industry funded trials (OR 0.89, 95% CI 0.50 to 1.60).”

This means that studies funded by the pharmaceutical industry found testosterone therapy to have no connection with adverse cardiac events, while independent studies found testosterone therapy more than doubles the risk for adverse cardiac events.

Due to the fact that the manufacturers of testosterone therapy products such as AndroGel, a popular topical testosterone gel, have failed time and again to warn users of the risk for cardiac arrest, stroke, and death associated with AndroGel, a number of AndroGel lawsuits have been filed.  If you or a loved one used AndroGel and suffered one of these side effects, you may be entitled to significant financial compensation for your injury.  For a free, no-obligation case consultation, contact our team of AndroGel lawyers at the information provided below.  We have the experience, resources, and skills required to win the compensation you deserve.

Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our AndroGel Lawsuit Information page is a great place to start if you have any questions about AndroGel.

In 2013, a team of medical researchers led by R. Vigen from The University of Texas at Southwestern Medical Center in Dallas published a report titled “Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels.” in JAMA that aimed to evaluate the connection between testosterone therapy and increased risk for heart attack, stroke, and death.

The authors write “Rates of testosterone therapy are increasing and the effects of testosterone therapy on cardiovascular outcomes and mortality are unknown” and “A recent randomized clinical trial of testosterone therapy in men with a high prevalence of cardiovascular diseases was stopped prematurely due to adverse cardiovascular events raising concerns about testosterone therapy safety.”  As such, the aim of this study was to “assess the association between testosterone therapy and all-cause mortality, myocardial infarction (MI), or stroke among male veterans and to determine whether this association is modified by underlying coronary artery disease.”

Studying a total of 8,709 men with low testosterone, of which 1,223 patients used testosterone therapy and 7,486 did not, the team found that 27.5% of men using testosterone therapy suffered serious adverse cardiac events, compared to only 19.9% of unmedicated men in that same period.  As such, Vigen et al. (2013) concluded that “the use of testosterone therapy was associated with increased risk of adverse outcomes” and state “These findings may inform the discussion about the potential risks of testosterone therapy.”

Due to the fact that the manufacturers of Androgel, a topical testosterone therapy drug, failed time and again to adequately warn men of the risk for heart attack and stroke associated with Androgel, a number of Androgel lawsuits have been filed.

If you or a loved one used Androgel and suffered heart attack, stroke, or death, you may be entitled to significant financial compensation from the manufacturer.  For a free, no-obligation case consultation, contact our team of Androgel lawyers at the information provided below.  We have the compassion, experience, and resources required to win the compensation you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

In 2014, a paper was published in the medical journal PLoS One by WD Finkle et al. titled “Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men.” studied the risk for heart attack suffered by users of testosterone therapy.

The authors state “An association between testosterone therapy (TT) and cardiovascular disease has been reported and TT use is increasing rapidly” and explain their study, writing “We conducted a cohort study of the risk of acute non-fatal myocardial infarction (MI) following an initial TT prescription (N = 55,593) in a large health-care database. We compared the incidence rate of MI in the 90 days following the initial prescription (post-prescription interval) with the rate in the one year prior to the initial prescription (pre-prescription interval) (post/pre).”

Overall, the risk for heart attack was 36% greater in men who used testosterone therapy.  In men over 65 years old, the risk for heart attack was 219% higher than for nonusers.  Men who used testosterone therapy under 55 years of age were found to be relatively safe, but men who were over 75 faced a risk for heart attack elevated by 343% compared to same-age nonusers.  In general, higher risk for heart attack in men under 65 was confined to those with history of heart disease.

Due to the fact that many men have used testosterone therapy such as Androgel unaware of the risk for heart attack associated with these products, a number of Androgel lawsuits have been filed.  If you or a loved one used Androgel and suffered heart attack or stroke, you too may be entitled to significant financial compensation from the manufacturer.  For a free, no-obligation case consultation, contact our team of Androgel lawyers at the information provided below.  We have the experience, resources, and skills required to win the compensation you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

The alpha-male. It’s a term traditionally used to describe an individual male mammal that is considered to hold the highest social standing in his community. Typically, an animal rises to alpha-male status by exhibiting signs of masculinity, confidence, and aggression to his peers. In acknowledgement of the alpha’s strength and leadership role, other members of the species often act subservient to the alpha, allowing him first dibs on all aspects of life, including food, sleeping places, and even mates.

Last year, the National Geographic channel ran a three-part series entitled, Going Ape, which showed that human males fight to be top-dog in much the same way mammals do in the animal kingdom. See http://natgeotv.com.au/tv/ape-man/episodes.aspx?series=1. The series suggested that men innately try to exhibit signs of masculinity, confidence, and aggression to their peers on a daily basis with the purpose of rising to alpha-male status. Instinctively, the high social standing seems to promise first pick in all of life’s essentials—careers, homes, and mates—to all who achieve it, and is thus vital.

Due to men being as sensitive as they are with regard to reaching, or else maintaining, alpha status, it is no shock that many men would take a diagnosis of low testosterone very seriously. What is shocking, however, is that there are companies who would prey on this anxiety.

Recent lawsuits have been filed involving a prescription drug called, AndroGel, which is manufactured, sold, distributed and promoted by AbbVie Inc. (hereinafter “AbbVie”) and Abbott Laboratories, Inc. (hereinafter, “Abbott”) as a testosterone replacement therapy. Defendants misrepresented that AndroGel is a safe and effective treatment for hypogonadism or “low testosterone,” when in fact the drug causes life threatening events, including strokes and heart-attacks.

The fatal problem began when defendant companies, AbbVie and Abbott, coordinated a massive, aggressive advertising campaign designed to convince men that they suffered from low testosterone—whether they actually did or not. As you can imagine, this sent a massive scare throughout the male universe. After all, it is testosterone that makes men…well, men. A lack of it could mean no-shot at even a beta status, let alone an alpha one.

A recent lawsuit was filed by Mr. Kelly in Illinois against the defendant companies. Mr. Kelly is only one of thousands of men who may have been harmed by AndroGel. His claims against the defendant companies include negligence, failure to warn, breach of implied warranty, breach of express warranty, fraud, and misrepresentation. The complaint states:

“Defendants orchestrated a national disease awareness media blitz that purported to educate male consumers about the signs of low testosterone. The marketing campaign consisted of television advertisements, promotional literature placed in healthcare providers’ offices and distributed to potential AndroGel users, and online media including the unbranded website “IsItLowT.com.” The television advertisements suggest that various symptoms often associated with other conditions may be caused by low testosterone and encourage men to discuss testosterone replacement therapy with their doctors if they experienced any of the “symptoms” of low testosterone. These “symptoms” include listlessness, increased body fat, and moodiness—all general symptoms that are often a result of aging, weight gain, or lifestyle, rather than low testosterone.”

As a result of the massive advertising campaign, hordes of men—most of whom had never been diagnosed with any kind of testosterone deficiency in their lives—flooded in to see their doctors, expressing concern that they suffered from low testosterone.

Tragically, doctors, too, had been bombarded by the defendants’ campaign. Since the FDA had approved AndroGel, the defendant companies convinced primary care physicians that low testosterone levels were widely under-diagnosed, and that conditions associated with normal aging could be caused by low testosterone levels. As a result, thousands of men were indeed prescribed the drug.

Tragically, what the consumers received were not safe drugs, but rather a product which causes life-threatening problems, including strokes and heart attacks.

Our firm is currently taking on new cases involving AndroGel. If you have been hurt by this dangerous product, or if you have lost a loved one due to his use of AndroGel, please don’t hesitate to call us. Additionally, if you are a physician who prescribed AndroGel to a client because you relied on the defendant companies’ promises with regard to AndroGel’s safety, we would be happy to speak with you.

As lawsuits concerning the testosterone therapy drug AndroGel have recently been filed, a great deal of information has come to light concerning the marketing of that product.

Here is an excerpt from one of the current AndroGel lawsuits:

“In 2000, when the FDA approved AndroGel, the company announced that the market was ‘four to five million American men.’ By 2003, the number increased to ‘up to 20 million men.’ However, a study published in the Journal of the American Medical Association (‘JAMA’) in August 2013 entitled ‘Trends in Androgen Prescribing in the United States, 2001-2011’ indicated that many men who get testosterone prescriptions have no evidence of hypogonadism. For example, one third of men prescribed testosterone had a diagnosis of fatigue, and one quarter of men did not even have their testosterone levels tested before they received a testosterone prescription.”

Does it really seem likely that the prevalence of hypogonadism would quadruple in three years, or does this simply look like a case of improper marketing?  It is interesting to note that when then-manufacturer of AndroGel, Unimed Pharmaceuticals, Inc., first sought AndroGel approval by the FDA in 1999, “hypogonadism was estimated to affect approximately ‘one million American men.’”  A twenty-fold increase in disease prevalence is staggering, and would represent an epidemic if it were real.  Thankfully, it isn’t.

However, the good news that hypogonadism isn’t so prevalent may likely be eclipsed by the prevalence of AndroGel use and the accompanying negative side effects — which include a dramatically-increased risk for heart attack and stroke.

WARNING: Research shows AndroGel (AbbVie, Inc., Abbott Laboratories, Inc.) is overprescribed and can lead to “serious medical problems, including life threatening cardiac events, strokes, and thrombolytic events.”

AndroGel is a topically-applied gel containing testosterone at concentrations of either 1% or 1.62% used by patients suffering from hypogonadism, or “low-testosterone”.  While this condition does persist in American society today, “Low-T” isn’t nearly as prevalent as the aforementioned companies have led many to believe through what has become an award-winning marketing campaign.

As of February 7th 2014, the United States District Court for the Northern Division of Illinois (Eastern Division) began handling a lawsuit against the manufacturers of AndroGel, in which it is alleged that these companies “participated in, authorized, and directed the production and promotion of [AndroGel] when they knew, or with the exercise of reasonable care should have known, of the hazards and dangerous propensities of [AndroGel] and thereby actively participated in the tortious conduct which resulted in the injuries suffered by [our client].”

It is also noted that the client mentioned above could not have come to know the dangers posed by AndroGel sooner due to the fact that AbbVie and Abbott Laboratories “misrepresented and continue to misrepresent to the public and to the medical profession that the drug AndroGel is safe and free from serious side effects,” stating that these companies “have fraudulently concealed facts and information that could have led [our client] to discover a potential cause of [the side effects experienced].”

This is one of three similar such lawsuits filed that day, all raising the same concerns regarding AndroGel safety and marketing.  To elucidate those concerns, this lawsuit cites several scientific studies.  First, the team cites a 2010 New England Journal of Medicine Study titled “Adverse Events Associated with Testosterone Administration” that was stopped because too many men experienced negative side effects.  Next, the team cites a 2013 Journal of the American Medical Association study titled “Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men with Low Testosterone Levels,” “which indicated that testosterone therapy raised the risk of death, heart attack and stroke by about 30%.”

Another study released January 29th of this year was cited, titled “Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men” determining testosterone therapy doubled the risk for heart attack in men over 65 and younger than 65 who had a history of heart disease.

Though AndroGel commercials describe some of the possible negative side effects of the product, particularly those that can follow by secondary contact (handling the clothes of a person who had applied AndroGel), the risk for heart attack and stroke is absent from their warnings.

As more information becomes available regarding AndroGel lawsuits and the danger of AndroGel, we will be sure to pass the knowledge on to you.  If you or a loved one used AndroGel, you too may be eligible for significant financial compensation as this AndroGel lawsuit proceeds.  For more information, or a free, no-obligation case consultation, contact our team of AndroGel lawyers at the information provided below.  We have the compassion, experience, and resources to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us