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Law Offices of Thomas J. Lamb

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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Learn more on our Testosterone Products Information Page

Tekturna Should Not Be Used In Combination With Certain Other Blood Pressure Drugs Due To Side Effects Hyperkalemia And Kidney Problems, Says Health Canada

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In Addition, Such Combined Use In Patients With Kidney Disease Or Diabetes Increases Risks Of Having A Stroke As Well As Fainting And Falling

 
SUMMARY: In February 2014 Health Canada issued “New warnings regarding blood pressure drugs” which includes safety information about the drug Tekturna (aliskiren) as regards its use in combination with some other blood pressure medications.

We have written in more detail about the increased risks of serious side effects associated with Tekturna in this 2012 article: “Tekturna And Other Aliskiren Related Blood Pressure Medications Can Cause Renal Failure, Kidney Complications, And Strokes”.

Of course, we will continue to monitor the safety issues involving Tekturna, and report significant developments here.

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Learn more on our Tekturna Information Page

Multaq: Increased Risks Of Side Effects, Including Death, Outweigh Any Benefits Say Researchers Who Reviewed Clinical Data

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In Addition, They Are Highly Critical Of Relationship The Sanofi Aventis Drug Company Had With Those Doctors Who Developed Prescribing Guidelines

 
SUMMARY: The importance and significance of a February 2014 JAMA Internal Medicine article about Multaq is presented well by this report, “Dronedarone and Clinical Guidelines: A Dark Chapter That Must Be Reread”, that was published on the Medscape website.

From that Medscape piece by reporter John Mandrola:

The story of how a marginally effective and perhaps even hazardous drug made it to first-line status of major guideline documents is a hard image to revisit. Also difficult to look back at were the lavish steakhouse dinners, the webinars, the “sponsored” programs, and then the result: legions of general cardiologists and primary-care doctors prescribing [Multaq (dronedarone)] en masse. With [Multaq (dronedarone)], for a time at least, hype trounced science…. [emphasis added]

We know, now, since being approved by the FDA in 2009 and soon becoming an often-prescribed atrial fibrillation drug, Multaq has been associated with increased risks of serious side effects, including liver failure, interstitial lung disease (ILD), stroke, and sudden cardiac death.

[Read this article in full at original source]

Learn more on our Multaq Information Page

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