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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:
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.
Earlier articles by attorney Tom Lamb on the Side Effects Blog:
- 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
- AndroGel / Axiron / Testim: Heart Attacks, Strokes, And Other Cardiovascular Problems Will Be Subject Of FDA Advisory Panel Meeting In September 2014
- Summer 2014 Update: Testosterone “Low-T” Drugs: New FDA Safety Warnings; Recent Medical Journal Article About Heart Risks Of Injectable TRT Products
- The Benefits And Risks Of Popular Testosterone Replacement Therapy For Older Men Are Not Fully Known
- Testosterone Drugs Litigation April 2014 Update: Legal & Medical Developments: AndroGel Federal Court MDL Motion Is Filed, And A “Low-T” Medical Study Is Criticized
- For Testosterone Therapy Drugs Like AndroGel / Axiron / Testim: Add “Black-Box” Warning To Label: Public Citizen’s Petition To FDA
- More Evidence Supporting A Link Between Testosterone Therapy And Higher Risk Of Cardiovascular-Related Events Such As Myocardial Infarctions Or Heart Attacks
- The Growing Use Of Testosterone Creams, Gels, Injections, And Patches Raises Increased Concerns About Risks Of Cardiac Side Effects
- Increasingly Popular Testosterone Replacement Therapy Drugs Are Linked To Myocardial Infarctions Or Heart Attacks, Strokes, And Deaths
We encourage you to submit a Drug Injury Law Case Review – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible drug injury case. Either way, you will get Mr. Lamb’s impressions — not an intake person, a paralegal, nor some other lawyer — about your case based on his many years of experience.
“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
All content by attorney Tom Lamb