Heart Risks with Androgel, Testim, Other Low T Drugs Require Much Closer Look
The need for more testing of testosterone drugs is becoming increasingly clear, in the face of a growing industry and a mounting number of men who are allegedly suffering heart attacks, strokes, blood clots and sudden death while using widely advertised “Low T” drugs.
In a recent report published by the Journal of the American Medical Association (JAMA), a group of prominent medical experts urged the FDA to act on recent recommendations of an independent advisory committee and require manufacturers of testosterone replacement therapy products to finally conduct studies to evaluate the potential testosterone heart risks.
Over the last year, concerns have emerged regarding the widespread over-use of popular medications like Androgel, Testim, Axiron and others, as well as questions about the potential side effects of testosterone drugs and whether users may face an increased risk of serious and potentially life-threatening injury.
Have You or a Loved One Suffered Heart Problems on Androgel or Another Low T Drug?
A series of independent studies were published in late 2013 and early 2014, which suggested that certain men may face serious heart risks from AndroGel and other low T drugs.
In response to the concerns, the FDA convened an Advisory Panel in September, which reviewed the available data and called for use of the drugs to be restricted to men who have a true medical need. The Panel also concluded that the manufacturers of these widely marketed drugs have failed to adequately study the potential testosterone heart risks, and recommended that the FDA require additional testing.
“The emergence of [testosterone replacement therapy] as a multibillion-dollar industry without appropriate supporting data or oversight of its proper usage emphasizes the need for stricter controls as well as reassessment of approval pathways when the usage is not consistent with approved labeling,” wrote Dr. Marc B. Garnick, of Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, in the report.
Testosterone Drug Risks
The article viewpoint expresses concerns over the rapid spread of “low T” drugs and the lack of prior testing of their efficacy or regulation of advertisements. Garnick points out that, over time, use of testosterone has shifted from real cases of hypogonadism causing low testosterone levels, to age-related reduction of testosterone for men seeking to improve energy levels, strength and sex drive as they get older.
“In part, the loophole that allowed [low T drug] usage in aging males was perhaps enabled by the inclusion in the indication of ‘idiopathic’ hypogonadism and applying that term to age-related decline in testosterone,” Garnick notes. “The panel did not hear any convincing data from well-controlled clinical trials that TRT provided clinical benefit and was safe to administer in the aging male population.”
Garnick notes that between 2010 and 2013 the number of patients receiving low-t drug therapy increased from 1,299,846 to 2,291,266 in the U.S. He also points out that a sample of nearly 250,000 men showed that only 72% of those on testosterone drugs had their testosterone levels actually tested first.
He points to aggressive marketing tactics for low T drugs, which may have abused the regulatory system as a potential culprit. Low-T commercials and information programs often name no particular product and are considered Disease Awareness Campaigns, falling under the purview of the Federal Trade Commission, he notes. However, commercials for specific products fall under FDA regulation.
“Claims of efficacy, ascribed to a particular product but not supported by labeling and data are regulated under the Federal Food, Drug, and Cosmetics Act and the FDA can issue warnings to the offending manufacturer,” He wrote. “In practice, manufacturers of TRT products may have exploited this separation of regulatory authority by introducing the low T disease concept followed by carefully scripted portrayals of actual products that address symptoms of low T.”
Low T Drug Lawsuits
Over the course of this year, hundreds of Androgel lawsuits, AndroDerm lawsuits, Testim lawsuits, Axiron lawsuits and other testosterone drug lawsuits have now been filed in courts throughout the U.S.
All of the complaints allege that the manufacturers failed to adequately research the medications or warn about the potential risk that men may suffer a heart attack, stroke, pulmonary embolism, deep vein thrombosis or other serious injury.
Plaintiffs claim that the drug manufacturers placed their desire for profits before consumers safety, by aggressively marketing the use of Low T drugs without ensuring they are safe and effective for the vast majority of men using the products. It appears that a growing number of experts in the medical industry are coming to a similar conclusion.
The testosterone drug lawyers at Saiontz & Kirk, P.A. are continuing to review potential claims for men throughout the United States who may have suffered an injury as a result of the inappropriate use of these medications. To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.