The Legal Examiner Affiliate Network The Legal Examiner The Legal Examiner The Legal Examiner search instagram avvo phone envelope checkmark mail-reply spinner error close The Legal Examiner The Legal Examiner The Legal Examiner
Skip to main content

Due largely to drug makers’ aggressive direct-to-consumer advertising campaigns, testosterone replacement therapy (TRT) has become a big business projected to reach profits of $5 billion by 2017.  But, huge profits should not come with a huge price to pay for consumers.

The FDA said that testosterone replacement therapy (TRT) has only been approved for treating men who have hypogonadism, a form of abnormally low testosterone caused by injury or medical illness, yet many advertisements encourage older men to use testosterone replacement therapy if they are experiencing decreased sex drive, weight gain, depression or lack of energy.  While use of testosterone drugs, such as AndroGel has increased dramatically over the past ten years, concerns have emerged in recent months about serious and potentially life-threatening side effects.

In November 2013, a study published in the Journal of the American Medical Association found that testosterone drug side effects were linked to increased risks of heart attacks, strokes, and death among older men with certain pre-existing heart problems.  That research was followed by another study released in January 2014 by the medical journal PLOSOne, which found that men who take such testosterone drugs are 30% more likely to experience a heart attack, stroke, or die suddenly regardless of their prior heart conditions.  The study also reported that about 25% of men who received prescriptions for testosterone boosters were granted them without undergoing blood tests to check their testosterone levels.

The results of these studies raise many questions about why the drug makers did not warn consumers and the medical community after an aborted 2009 study.  Additionally, why did the FDA recently approve Aveed; a drug it previously rejected three times due to safety concerns without requiring a black box warning?  A black box warning, the strongest warning that the FDA requires, signifies that medical studies indicate a drug carries a significant risk of serious or even life-threatening adverse reactions.

As the FDA reviews these recent concerns, it urges health care professionals and patients to report side effects involving prescription testosterone products to the FDA MedWatch program.

It’s clear that drug makers are reaping the rewards of successful marketing of testosterone treatments; they are putting profits over the safety of the consumer.  All drugs have some risks and a physician and patient should balance the benefits versus the risks to decide a course of medical therapy, but when advertisements and product labels don’t mention need-to-know risks, especially those serious and life-threatening, it is pure negligence.

These products should be safe before reaching consumers. Deceitful marketing tactics show the lengths drug companies will go to make billions of dollars without considering the safety of consumers.  Making a mistake is bad business; refusing to face the facts and at least warn consumers about the risks associated with one’s product is shameful. Lawsuit Financial supports all efforts to hold drug companies responsible for producing safe products and warning about dangerous ones.


  1. Gravatar for Jagger Knox
    Jagger Knox

    I agree that the doctors who prescribe TRT without blood work indicating depleted levels is Medical Negligence. I for one, am a Plainttiff's Attorney who is actually on TRT. I am 41 years old and have used it for approx 3 years with zero side effects. I have routine blood work done, and take a reasonable dose to bring me to my 30 year old baseline. How that can cause me to have a heart attack baffles me. It has made my life much, much better and I plan to be on it for the rest of my life. In fact, my 74 year old father who teaches Law at NYU is on it as well and says the same thing. Test is an important part of the male physical, emotional and psychological make-up and without it, I felt weak, slept too much, was uninterested, let too many things go without objecting to avoid confrontation, etc. Believe me, I am NO fan of big Pharma, but it is the unscrupulous Doctors that prescribe too much of it, in cream form (the more dangerous mode of administration), without a diagnosis that should be held liable. But in California, Juries believe Doctors can do no wrong (what a horrible joke that is), so maybe going after ugly pharma is the only way to eliminate this "problem." I hope not. It is a legitimate medication for a legitimate condition that increases the quality of a man's life exponentially.

  2. Gravatar for Connie McClellan
    Connie McClellan

    My husband had 2 stints inserted 10 years ago. About a year ago, he started taking testosterone shots administered by his doctor, In addition, he was taking supplements that he ordered over the internet!!! He died suddenly October 2013 of a presumed heart attack. We didn't do an autopsy and furthermore was cremated, so it can't be proven, but I'm convinced there is relevance between the testosterone and his death. People need to understand...when you get don't have the energy and sex drive that you used to....accept it!!! The drug companies are only real winners in these situations. preying on people who complain of the normal side effects of aging. AND, the doctors are also responsible, by administering these drugs without investigation or regard for possible consequences.

  3. Gravatar for Mark Bello
    Mark Bello

    Important advice for all of us "aging" adults, Connie. Thanks for commenting. I'm sorry for your loss. Regards, Mark

Comments for this article are closed.