The U.S. Food and Drug Administration (FDA) has issued a warning about testosterone replacement therapies and drugs.
In January 2014, the FDA conducted an investigation into the correlation between strokes, heart attacks, and deaths among men taking testosterone replacement medications. Some of the medications under investigation included Testim, Fortesta, and AndroGel. At the time, the FDA warned the public that these medications should only be used for those in genuine need of testosterone replacement, and that they were not permitted for those suffering from age-related testosterone issues.
As of 2017, the FDA has approved class-wide label changes for prescription testosterone products. The latest addition discusses the risks of abuse and dependency on these testosterone replacement therapies.
In general, the FDA warning is meant more for the physicians prescribing than the patients taking the therapies. However, the FDA does warn that these drugs could lead to addiction and abuse. Therefore, physicians must adequately monitor their patients to ensure that they do not become addicted or start to abuse their therapies.
Under the 1990 Anabolic Steroids Control Act, testosterone is classified as a controlled substance. When testosterone is taken at higher levels – usually those higher than prescribed – teens and adults alike could abuse the substance. Bodybuilders and athletes have been known to abuse testosterone therapies. Doing so, however, can result in serious side-effects, including:
The new warning issued by the FDA tells prescribers that their patients could abuse the drugs with serious consequences. Prescription testosterone therapy is FDA-approved, but only for men with low testosterone because of a medical condition.
Sometimes, men have low testosterone because of genetic conditions, infection, damage to the testicles, or as a result of chemotherapy.
The FDA has known about the potential risks of abuse and addiction for testosterone replacement therapies for some time. Some question why the FDA would issue this warning years after the initial discovery.
Some believe the release of the warning is because there has been a rise in the number of patients using testosterone therapy compared to several years ago. Also, manufacturers of these drugs are aggressively advertising them to men, highlighting them as a cure-all for testosterone issues. In fact, most consumers have heard the phrase “Low T” in an advertisement. Most of these prescription advertisements encourage men to speak to their physician about their low testosterone, and to seek treatment.
Between 2009 and 2013, the number of men taking prescription testosterone therapy increased by 75 percent, according to the FDA’s own numbers. Some prescribers are issuing testosterone therapy now without performing the necessary testing to ensure that the patients are appropriate candidates. In fact, a 2014 study in the Journal of Clinical Endocrinology and Metabolism found that 40.2 percent of men on testosterone replacement did not have an actual testosterone test within 180 days before starting their therapy. Also, 50 percent of male patients on the drugs only received a single test to assess candidacy. Typically, a physician will order more than one testosterone test to adequately determine the patient’s levels and to see if he is a fit for the treatment.
Testosterone addiction is nothing new. In fact, athletes and bodybuilders use anabolic steroids, which have compounds that mimic male testosterone, to gain muscle mass quicker and boost energy levels. This is why the Olympic Committee banned the use of all steroids in 1975, according to Science Magazine. Then, in 1991, the United States Drug Enforcement Agency (DEA) labeled them as a controlled substance.
Testosterone is now in the same category as heroin and cocaine. Those who quit the use of testosterone could suffer from withdrawal symptoms, such as depression and anxiety.
While the percentage of adults who are addicted to testosterone is not known, there is a high potential for testosterone users to become addicted. The issue of addiction is the withdrawal. Depressive symptoms are the most dangerous withdrawal symptom, and these symptoms have been known to last a year or more in some patients after stopping testosterone treatments. Of course, there is no telling at what point a patient risks becoming addicted – or the specific amount of testosterone therapy medications required to cause addiction – at this time.
There is a big loophole in FDA regulations, which allows manufacturers of pharmaceuticals to market and urge customers to talk to their physicians about “possible signs” of a condition. In this case, they are urging men to talk to their physicians about the potential signs of low testosterone.
These advertisements will cite symptoms that anyone could experience, including those without low testosterone. For example, one commercial discusses being tired or having no energy as a symptom. While this is a symptom of low-T, it is also a symptom for numerous other conditions.
One of the biggest reasons why men become addicted to testosterone is that when they start the therapy, they start to feel great. They have energy, their sex-drive returns, and their mood improves. While on the therapy, however, their body stops producing testosterone on its own. So, coming off the therapy is devastating to the body’s systems.
Beyond addiction, there are several other risks to testosterone therapy. Some of these risks include:
In this case, it could be both. If a patient were to become addicted to his testosterone treatment, the manufacturer could be liable for encouraging men to take the prescriptions for everyday problems. The physician could be liable for not monitoring the patient, or for prescribing unnecessary medications that led to addiction. However, in most patients’ cases, it would be the physician who holds most of the liability.
A man replacing low testosterone levels with testosterone therapy will notice that the treatment is highly effective. In fact, within a few days of taking it, a man will notice his symptoms of “low testosterone” are gone. Unfortunately, the risk of addiction sets in when the man starts to feel an improvement. If he were to stop taking the testosterone, he will notice that he no longer feels great, which could give rise to several medical complications.
For a patient’s testosterone addiction to qualify as medical malpractice, one must first understand this practice of law.
A physician’s actions (or lack thereof) are typically to blame in malpractice cases, but like all injury cases, it comes down to negligence. Not all unfavorable outcomes are malpractice, and not all cases of testosterone addiction would be considered malpractice. Instead, the physician’s negligence must play a role in the patient’s addiction.
To prove that your physician was negligent in your testosterone addiction, your medical malpractice lawyer will request all medical records relating to the testosterone therapy. He or she will then consult with a medical expert who will review those records. Typically, a qualified physician with a similar background to your treating physician is the expert who will review your records.
After reviewing the medical records, the expert witness and your medical malpractice attorney will look for signs of negligence. There are several instances where this may occur:
If you suspect your testosterone addiction is due to physician negligence, or if you suffered a side-effect that you were not properly warned of, you may have a claim for malpractice. It is important that you consult with a malpractice lawyer who can review your medical records and determine if physician negligence was a factor. A medical negligence attorney also has access to the resources necessary to prove your case. Malpractice claims are especially difficult, and they often rely heavily on expert testimony and medical records.
The malpractice team at Berkowitz and Hanna, LLC is here to help. Addiction is very serious, and it carries long-term consequences and costs, and could impact you for the rest of your life. Let our attorneys ensure that you receive the compensation and treatments you need to recover.
Contact Berkowitz and Hanna LLC today to schedule a no-obligation case evaluation.
Berkowitz Hanna
