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Law Offices of Thomas J. Lamb

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

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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 testsoterone 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.

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Testosterone Drugs FDA Meeting In September 2014 Reveals That The Safety Of Products Like Axiron, AndroGel, And Testim Is Uncertain Or Unknown At Present Time

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Key Advisory Panel Member Concedes It Is Medically Plausible That Testosterone Replacement Therapy Can Be Associated With Heart Attacks / Strokes Side Effects

 
SUMMARY: In mid-September 2014 members of two FDA advisory panels in a joint meeting considered the issue of whether the popular testosterone products Axiron, AndroGel, and Testim, as well as other so-called “Low-T” drugs, are safe.

We have to wait to see what regulatory action the FDA will take, if any, concerning the possible increased risks of heart attacks and strokes that some link to these testosterone replacement therapy drugs.

The outcome of their discussions was essentially that for most current users of Axiron, AndroGel, Testim, and other “Low-T” drugs we do not know and cannot know if they cause such cardiovascular side effects because no safety study has been done, yet.

[Read this article in full at original source]

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Testosterone Replacement Therapy Drugs
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AndroGel / Axiron / Testim: Heart Attacks, Strokes, And Other Cardiovascular Problems Will Be Subject Of FDA Advisory Panel Meeting In September 2014

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Health Canada Orders Label Change For Testosterone Drugs In July 2014: Must Warn About Increased Risks Of Side Effects Including Blood Clots, DVTs, PEs

 
SUMMARY: We will start with the FDA, which on July 17, 2014 issued this “September 17, 2014 Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement”:

Agenda: The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use.

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

[Read this article in full at original source]

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Testosterone Replacement Therapy Drugs
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Summer 2014 Update: Testosterone “Low-T” Drugs: New FDA Safety Warnings; Recent Medical Journal Article About Heart Risks Of Injectable TRT Product

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All Testosterone Therapy Drugs Need To Warn About Blood Clots Side Effects Like DVT And PE; Older Depo-Testosterone Product May Be Safer Than New Gels Such As AndroGel And Testim

 
SUMMARY: We will start with two recent FDA developments:

1. Testosterone: Drug Information Update- FDA adding general warning to testosterone products about potential for venous blood clots [Issued 6/19/14]

2. Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between January – March 2014 [Page / List Updated 6/16/14]

Now we shift to the medical journals and, in particular, an article published online July 2, 2014 by the Annals of Pharmacotherapy, “Risk of Myocardial Infarction in Older Men Receiving Testosterone Therapy”.

We will continue to monitor this still emerging drug safety issue concerning Depo-Testosterone, Testim, AndroGel, Axiron, and other testosterone products — also called TRT and/or “Low-T” drugs.

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The Benefits And Risks Of Popular Testosterone Replacement Therapy For Older Men Are Not Fully Known

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This Uncertainty About Drug Safety Of AndroGel, Axiron, Testim, And The Like Is Causing Concern Among Doctors

 
SUMMARY: The lead investigator on the Testosterone Trial in Older Men clinical study (known as the T Trial) that was sponsored by the US National Institutes of Health, Dr. Peter J. Snyder, of the University of Pennsylvania, has already warned that this T Trial, designed to enroll fewer than 800 men, will only be large enough to detect the benefits of testosterone drugs, but not any of the risks.

This continuing uncertainty about the possible cardiovascular side effects, e.g., heart attacks and strokes, caused by AndroGel, Axiron, Testim, and other testosterone replacement drugs — “uncertainty” because there has never been an appropriate clinical study to assess the drug risks — is increasingly a drug safety issue being discussed among doctors.

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Testosterone Drugs Litigation April 2014 Update: Legal & Medical Developments: AndroGel Federal Court MDL Motion Is Filed, And A “Low-T” Medical Study Is Criticized

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Increasing Number Of AndroGel / Axiron / Testim Lawsuits Allege Heart Attacks And Strokes, With Highest Side Effects Risks Being For Older Men Or Those With Cardiac Conditions

 
SUMMARY: First, it comes as no surprise to legal observers that a so-called “MDL motion” to consolidate the federal court drug injury lawsuits alleging heart attacks and strokes being caused by the testosterone replacement therapy product AndroGel, with the Defendants being Abbott Laboratories and AbbVie Inc.

Moving from the legal side to the medical side, in a March 2014 letter a previously unknown / new group of doctors, the Androgen Study Group (ASG), has requested the retraction of an article about testosterone drugs side effects which was published by the Journal of the American Medical Association (JAMA) in November 2013.   See our earlier report about this JAMA article:  “Increasingly Popular Testosterone Replacement Therapy Drugs Are Linked To Myocardial Infarctions Or Heart Attacks, Strokes, And Deaths.”

Be assured that we will continue to monitor both the medical and legal aspects of this still relatively new litigation involving AndroGel, Axiron, Testim, and other testosterone replacement products.

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For Testosterone Therapy Drugs Like AndroGel / Axiron / Testim: Add “Black-Box” Warning To Label: Public Citizen’s Petition To FDA

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Earlier In February 2014 The Endocrine Society Of Medical Doctors Urged Caution In The Prescribing Of These Products To Certain Middle-Aged And Older Men

 
SUMMARY: In late February 2014 the consumer advocacy group filed a Petition with the FDA requesting that a “Black-Box” warning about the increased risks of heart attacks, strokes, and other cardiovascular dangers, including cardiac deaths, be added immediately to the drug labels of testosterone replacement therapy (TRT) products such as AndroGel, Axiron, and Testim.

Less than three weeks before this FDA Petition was filed by Public Citizen as regards the safety profile of these commonly called “Low-T” testosterone drugs, the Endocrine Society, a leading group of medical doctors, expressed their concern about recent studies pointing to increased risks for cardiovascular events after the start of new testosterone therapy.

We are currently investigating possible drug injury and death legal claims against the pharmceutical companies responsible for AndroGel, Axiron, and Testim.

[Read this article in full at original source]

Learn more on our Testosterone Products Information Page

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Law Offices of Thomas J. Lamb, P.A.
1908 Eastwood Road, Suite 225
Wilmington, North Carolina 28403
910-256-2971 | 800-426-9535
TJL@LambLawOffice.com