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Testosterone Therapy Drugs


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March 2015 Update: “FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use”

On March 3, 2015 an FDA Drug Safety Communication about testosterone products was issued requiring drug companies to make a “labeling change to inform of possible increased risk of heart attack and stroke with use”.

From the Safety Announcement part of this March 2015 FDA warning:

The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions….

In addition, based on the available evidence from published studies and expert input from an 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.

Based on our findings, we are requiring labeling changes for all prescription testosterone products to reflect the possible increased risk of heart attacks and strokes associated with testosterone use.

In addition, the FDA is finally requiring the pharmaceutical companies that are responsible for AndroGel, Axiron, Testim, and other testosterone replacement products to conduct a clinical trial to address the drug safety issue of whether their “Low T” drugs can cause an increased risk of heart attack or stroke in some men using these products.


Testosterone Replacement Products Like Testim, Axrion, And AndroGel Linked To Heart Attacks, Strokes, And Deaths

Testosterone replacement therapy (TRT), also called androgen replacement therapy (ART), is medically recommended for men whose body makes too little of this male hormone. For those men who have been tested and diagnosed with this condition, which is called hypogonadism, testosterone drugs like Axiron, AndroGel, and Testim can serve to boost strength and sexual functioning.

But it is estimated the number of middle-aged men in the U.S. getting testosterone treatments has more than tripled over the last decade, with many of them never being tested nor diagnosed.

Moreover, according to medical researchers and the FDA these testosterone replacement therapy drugs have been associated with heart attacks / myocardial infarctions (MI) and ischemic strokes (CVA), as well as deep vein thrombosis (DVT) and pulmonary embolism (PE), with all of these side effect having the potential to cause death.

Some of the prescription testosterone drug products approved by the FDA and available for use to treat low testosterone, or “Low T” syndrome, include:

•  AndroGel
•  Androderm
•  Aveed
•  Axiron
•  Bio-T-Gel
•  Delatestryl
•  Depo-Testosterone
•  Fortesta
•  Striant
•  Testim
•  Testopel


Testosterone Injections Or Shots Such As Depo-Testosterone Might Have Higher Risks Of Heart Attacks, Strokes, And Deaths

New Medical Research Suggests The Safety Of A Testosterone Drug Might Depend On Its Form: Injections / Shots; Creams / Gels; Skin Patches

SUMMARY: According to a large retrospective cohort medical study published online by the JAMA Internal Medicine journal in May 2015, we learn that short-acting testosterone injections or shots — such as the Depo-Testosterone (testosterone cypionate) injection from Pharmacia and Upjohn Company (a division of Pfizer) — are associated with a higher risk of cardiovascular events, hospitalizations, and deaths when compared with gels or patches.

From a May 11, 2015 news report, “Testosterone Shots: Riskier Than Gels or Patches?” — with this sub-headline: “Spike in T levels from bolus injections may explain higher adverse outcome rates” — published online by MedPage Today, we get the following summary information and commentary about this testosterone drugs safety study:

“Different dosage forms lead to different serum testosterone levels over time — injections result in spikes and super-normal levels — possibly accounting for the observed risk of cardiovascular disease,” [J. Bradley Layton, PhD, an epidemiologist at the University of North Carolina Chapel Hill] and colleagues wrote….

The study is well-designed and done by a reputable group, said Bradley Anawalt, MD, an endocrinologist and professor of medicine at the University of Washington Medical Center, in an email to MedPage Today. But it only included short-acting forms of injectable testosterone (testosterone cypionate, enanthate, and propionate) and not the longer-acting testosterone undecanoate which is the most common form used in Europe and which was recently approved in the U.S.

The short-acting forms of injectable testosterone are associated with higher spikes in testosterone levels, said Anawalt, who was not involved with the study.

We will continue to watch for new medical research about testosterone drugs safety especially as regards heart attacks or myocardial infarction (MI), strokes, and cardiovascular deaths which might be caused by so-called “Low-T” testosterone therapy products such as Depo-Testosterone injections or shots.

[Read this article in full at original source]

Earlier articles by attorney Tom Lamb on the Side Effects Blog:


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Related resources:

“Possible cardiovascular problems associated with testosterone products”
Health Canada Information Update issued on July 15, 2014

“FDA adding general warning to testosterone products about potential for venous blood clots”
FDA Drug Information Update issued on June 19, 2014

“FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products”
FDA MedWatch Alert issued on January 31, 2014


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All content by attorney Tom Lamb

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