Medicinal Therapy for Low Testosterone in Men Has Serious Risks That Are Surfacing
By Dean I. Weitzman, Esq. on March 7th, 2014
The advertisements for “low-T” or low testosterone levels in men are appearing every day in television, newspaper, magazine and radio ads, but the still-developing serious health risks of such therapy appear to be the dark side of this recent phenomenon.
The problem is that while the creams and gels tout themselves as treatments for low testosterone levels in men, they also have been linked to escalating levels of heart attacks and strokes, according to a growing number of news sources.
“Older men considering taking testosterone for low libido, fatigue, irritability or muscle loss should be made aware of the heart-related risks of testosterone therapy, according to a statement from the Endocrine Society,” according to a Feb. 20 report from Reuters. “Drug companies tout testosterone as a near panacea for such conditions. But the U.S. Food and Drug Administration (FDA) has approved testosterone products only for hypogonadism, when the testicles do not produce enough testosterone.”
That means that testosterone therapy is not meant for age-related conditions and age-related decline in testosterone levels, the report stated.
Yet testosterone sales have been growing rapidly, from sales in 1988 that totaled between $18 and $20 million to sales of about$2.2 billion in 2013, the report stated.
In a paper on the subject, The Endocrine Society “cautioned against widespread use of testosterone drugs until large-scale trials can be completed,” Reuters reported. “The statement was partly a response to a decision by the FDA to investigate the risk of stroke, heart attack and death in men taking prescription testosterone.”
Patients who have underlying heart disease should be careful about using testosterone until more testing is done, the report said. “In January, findings from a PLOS ONE study of more than 55,000 men suggested those with a history of heart disease roughly double their heart attack risk in the first 90 days on testosterone therapy,” according to Reuters. “Another study looking at male patients from the Veteran Affairs system linked testosterone to an increased risk of death, heart attack or stroke.”
In the meantime, drug companies that sell testosterone treatments are touting it as the elixir for aging and as a cure all for a wide assortment of conditions that affect men as they age, from a low sex drive to depression and fatigue.
“By targeting men worried about weight, muscle tone, energy levels, mood and sexual satisfaction, the campaigns imply that treatment will help them become thinner, more muscular, more energetic, less grumpy and more sexually satisfied,” according to a recent story in The Los Angeles Times. “But there’s a big problem: We really don’t know if diagnosing and treating ‘low T’ does any good. More important, there is some evidence it may cause harm.”
These kinds of testosterone drugs “were initially developed for a narrow use: treating men with a reduced ability to produce testosterone because of such things as trauma, chemotherapy, genetic abnormalities or undescended testicles,” the story reported. “For these men, testosterone replacement provides a clear quality-of-life benefit, permitting normal sexual development or restoring male appearance and sexual function. In the years since the drug was first developed, the FDA has approved a whole medicine cabinet of testosterone products – gels, pills, patches and even an underarm roll-on.”
But questions are now increasing about just who should be receiving testosterone therapy, the report continues. “Drug information approved by the FDA is ambiguous about which conditions testosterone drugs are approved to treat. This matters because pharmaceutical companies can promote drugs only for ‘on-label’ FDA-approved uses. Years ago, the Institute of Medicine, the nation’s premier medical advisory group, described prescribing testosterone for low T as an off-label use. Last month, the FDA seemed to agree. In announcing its new investigation, the agency specifically mentioned that testosterone is approved only to treat hormonal problems caused by medical problems. So why has the FDA tolerated six years of aggressive marketing of the drug to a much wider range of potential patients?”
The Times article was clear in its criticism of such advertising campaigns. “It’s time for the FDA to rein in these kinds of ‘disease awareness’ campaigns and branded advertising, because they are misleading: They imply unproven benefits and ignore possible harms,” the story said.
Testosterone is a hormone, according to a report by WebMD, which puts hair on a man’s chest and is the force behind his sex drive.
As men age, especially after age 30, “most men begin to experience a gradual decline in testosterone,” which can result in a decrease in sex drive, the report stated. Often, however, that can be related to other health issues. “Doctors will want to rule out any such possible explanations for symptoms before blaming them on low testosterone,” the report states. “They will also want to order a specific blood test to determine a man’s testosterone level” to provide more information on the possible causes of the problems.
And that is one of the key issues in the escalating number of serious injuries being suffered by male patients who are using testosterone therapies – not enough testing and monitoring is being done to be sure that the patients are safe while using the hormone.
As a result, some patients are getting too high a testosterone level and they are having heart attacks, strokes and other serious medical problems.
These serious injuries are getting more and more attention in the legal community as well, as low-T cases appear to become the next wave of mass tort cases in courtrooms across the nation, according to a March 4 story in The Legal Intelligencer.
Like all other medical malpractice and personal injury cases, low-T therapy and the perils it can cause for patients reaffirms the need for patients and their families to be ever vigilant about the medical care they receive so they know what is being done for a patient’s care every step of the way. But at the same time, patients and families aren’t doctors and they can’t know every question to ask.
That’s where skilled, expert, compassionate and thorough legal representation is needed by patients and their families who have been harmed by low-T therapies. These kinds of cases are happening today on a regular basis, but they can be fought by legal teams that are prepared to battle for their clients’ rights all along the way to a fair settlement or to a just verdict.
We here at MyPhillyLawyer stand ready to assist you with your legal case if you or a loved one is ever seriously injured in a low-T medical malpractice or related case anywhere in the United States. We represent the families of victims who die in such tragedies as well, to ensure that their families receive every penny of damages that they are eligible to receive.
Call MyPhillyLawyer at 215-227-2727 or toll-free at 1-866-920-0352 anytime and our experienced, compassionate, aggressive team of attorneys and support staff will be there for you and your family every step of the way as we manage your case through the legal system.
When Winning Matters Most, Call MyPhillyLawyer.